1 SMF 2023

AMBEE PHARMACEUTICALS LTD.
184/1 TEJGAON INDUSTRIAL AREA, DHAKA-1208
Document No. Effective Date Review Date

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SMF/R/06 January 1,2023 December 31 ,2024
SITE MASTER FILE

FOR
AMBEE PHARMACEUTICALS LTE.

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Name Designation Signature Date

Md.Shamsuzzoha Asst. Production Manager
Quadria
Prepared By Mahabub Hasan Asst. Production Manager
Md Abdus Sobhan Senior Production Officer
Md.Al Mujahidee Asst. Quality Assurance
Manager
Approved By Abdur Razzak Asst. Quality Control
Manager
Somraj Debnath Asst. Manager Engineer
Reviewed By S.P. Barua Heat of Operation
TABLE OF CONTENT
Sl.No Particulars

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A Introduction
B Purpose
C Scope
D Referances
1.0 GENERAL INFORMATION
1.1 General Information of the Manufacturer
Chapter-1 1.1.1.1 Brief Description of the Manufacturer
1.1.1.2 Name and address of the Manufacturer
1.1.1.3 Name and street address of the site, buildings and production units located on
the site
1.1.2 24-hours contact information including incase of Product defects
1.2 Authorised Pharmaceuticals Manufacturing Activities of the site
1.3 Any Other Manufacturing Activities Carried out on the Site
Chapter-2 2.0 QUALITY MANAGEMENT SYSTEM
2.1 The Quality Management System of the Manufacturer
2.1.1 Brief description of the Quality Management Systems run by the company and
reference of the Standards used
2.2 Release Procedure of Finished Products
2.3 Management of Supplier And Contractor
2.4 Quality Risk Management
2.5 Product Quality Reviews
Chapter-3 3.0 PERSONNEL
3.1 Trainning Scheme
3.2 Health Requirement of All Personnel Working in Factory
3.3 Personnel Hygiene Requirement Including Clothing
Chapter-4 4.0 PREMISES AND EQUIPMENT
4.1 Premises
4.1.1.1 Short description of Plant: Size of the Site and list of
Building and short description of the Manufacturing area.
4.1.1.2 Nature of Construction and Finishes
4.1.2 Brief Description Of Heating, Ventilation And Air Conditioning (HVAC)
System.
4.1.3 Brief Description Of Effluent Treatment Plant (ETP)
4.1.4 Brief Description Of Water Systems
4.1.5 Brief description of other relevant utilities such as steam, compressed air,
Nitrogen etc.
4.2 Equipments
4.3 Qualification, Validation And Calibration
Chapter-5 5.0 DOCUMENTATION
5.1 Preparation,Revision and Distribution of Documentation
5.1.1 Preparation
5.1.2 Revision
5.1.3 Distribution
5.1.4 Storage

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5.2 Other Documentation Related to Product Quality

5.3 Document Review Committee
Chapter-6 6.0 PRODUCTION
6.1 Type of Products
6.2 Process Validation
6.2.1 Brief Description of General Policy for Process Validation
6.2.2 Policy For Reprocessing or Reworking
Chapter-7 7.0 MATERIAL MANAGEMENT AND WAREHOUSING
7.1 Arrangement for the handling of starting materials, packaging materials, bulk
and finished products including sampling, quarantine, release and storage.
7.2 Arrangement For The Handling Of Rejected Materials And Products
Chapter-8 8.0 QUALITY CONTROL
8.1 Description Of The QC Activities Carried Out On The Site In Terms Of
Physical, Chemical And Microbiological And Biological Testing.
8.1.1 In Brief Description Of The Activities Of QA/QC
8.1.2 Facilities Lies In Qc Laboratory Are:
8.1.3 Head Of QA/QC And Concerned Qualified Personnel Are Conscious About
Analysis And Testing In The Field Of:
8.2 Physical, Chemical, Microbiological And Biological Scope Of Testing In The
Field Of:
8.3 Release Of Finished Products
8.4 Short Description Of Quality Assurance
8.5 Other Activities
Chapter-9 9.0 DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND
RECALL
9.1 Distribution (To The Part Under The Responsibility Of The Manufacturer)
9.1.1 Types And Location (Regional Economic Area) Of The Companies To Which
The Product Are Shipped From The Site
9.1.2 Description Of The System Used To Verify That Each Customer/Recipient Is
Legally Entitled To Receive Medicinal Product From The Manufacturer.
9.1.3 Brief Description Of The System To Ensure Appropriate Environmental

Conditions During Transit E.G. Temperature Monitoring Control.
9.1.4 Arrangement For Product Distribution And Method By Which Product
Traceability Is Maintained.
9.1.5 Measures Taken To Prevent Manufacturer’s Product Tending Into The Illegal
Supply Chain.
9.2 Complaint, Product Defects And Recalls
9.2.1 Brief Description Of The System For Handling Complaint, Product Defects
And Recalls
9.2.2 Product Defects
9.2.3 Recall Product
Chapter-10 10.0 SELF INSPECTION

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10.1 Short Description of the Self Inspection System

10.2 Criteria Used for Selection of the Area to be Covered During Planned
Inspection and Practical Arrangement.
10.2.1 Self-Inspection Team
10.3 Arrangement and Follow up Activities
APPENDICES
APPENDIX-1 Manufacturing License

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APPENDIX-2 GMP Certificate

APPENDIX-3 ISO Certificate
APPENDIX-4 List of Products
APPENDIX-5 List of Export Products
APPENDIX-6 Map of Factory Location in Local Area
APPENDIX-7 Photograph of Factory Front View
APPENDIX-8 Factory Organogram
APPENDIX-9 List of Qualified Personnel
APPENDIX-10 Management list of Factory
APPENDIX-11 List of Trainers
APPENDIX-12 List of Key Personnel
APPENDIX-13 List of Self-Inspection Team
APPENDIX-14 List of Process Validation Team
APPENDIX-15 List of Equipment Qualification Team
APPENDIX-16 List of Document Review Committee
APPENDIX-17 Site Layout Plan
APPENDIX-18 Schematic Diagram of HVAC System
APPENDIX-19 Hydraulic Diagram of Purified Water Plant
APPENDIX-20 Diagram of Effluent Treatment Plant (ETP)
APPENDIX-21 List of Machineries and Equipments
CHAPTER 1

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A INTRODUCTION:
A Site Master File is a document prepared by AMBEE PHARMACEUTICALS containing specific and
factual GMP information about quality management policy and activities of the Site, the Production and/or
control of Pharmaceutical Manufacturing Operations carried out at the named site and closely integrated
operation at adjacent nearby buildings.
A Site Master File (SMF) is a document that requests the license holder or applicant to provide, that describes
the structure of the Organization involved, the site, the manufacturing activities carried out, the facility and
premises employed and also details of the quality management system in place.
An SMF contains adequate information as far as possible of the Organization behavior for the Quality Product
preparation. Though regular review we can ensure that this SMF is up to date representatives of current
activities.
B PURPOSE:
The purpose of SMF is to provide the update concept of the activities of the Manufacturer to the
regulatory authority that under the guidance of WHO’s GMP regulations are in progress and in
practice for safe and Quality Product preparation.
C SCOPE:
The Scope of SMF is to apply for maintaining all kinds of manufacturing operations such as
production, packaging, labeling, testing and product control system of all types of medicinal
products preparation in right truck.
D REFERENCES
World Health Organization WHO’S Technical Report Series No.961, 2011, Good Manufacturing
Practice (GMP) for Pharmaceutical Product: Main Principle
 Remington’s Pharmaceutical Sciences 16th Edition
 Prepare UR SMF According to TRS 961
 The Theory and practice of Industrial Pharmacy second Edition
By: Leon Lachman Ph.D Herbart A.Liberman Ph.D
Joseph I.Kanig Ph.D
 Drug Formulations Manual
By: D.P.S Kohli
1.0 GENERAL INFORMATION


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1.1 GENERAL INFORMATION OF THE MANUFACTURER:
1.1.1.1 Brief Description of the manufacturer:
The Company was established in 1976.The Company was run under the Chairmanship of Mr. Aziz
Mohammad Bhai along with 6 other directors. It is a public Limited Company having the number of
share holders around 2662.
1.1.1.2 Name and address of the Manufacturer: AMBEE Pharmaceuticals Ltd.

184/1, Tejgaon Industrial Area, Dhaka-1208
1.1.1.3 Name & street address of the Site, buildings and production units located on the site.
 Name and Street address: Adjacent to Bublee Masjid,Akij Group Ltd. A Site layout plan showing.
(Enclosed please find in Appendix-7)
 A map of Local area showing location of the site. Enclosed please find in Appendix-6
Buildings: Ambee Pharmaceuticals is of three(3) storied Buildings with all utilities facilities
are:
Production Building:
 Production area-16,000Sq.ft
 AC Facilities -120 Ton (Both ground, 1st floor& 2 nd floor)
 Other than PDB alternative Source of Electricity-Self 500 KVA
 Boiler (Steam Generator)-2 Ton Boiler
 Effluent Treatment Plant (ETP) -1000 Liter per Hour
 Water Facilities-Self deep Tubewell.
 We have Non –Penicillin Injectable Product preparation area dedicated
in 1st floor under HVAC System & Microbiology Department also HVAC System
Production unit:
 We are one of the leading National Pharmaceutical Company Producing life saving drugs
of Tablets, Capsules, Syrup, Suspension and Injectable items.
 Ground floor –Solid&Liquid preparation,Blister stripping and Packing of all product
including all types coatings and IPQC room (See Appendix-17)
 1st floor- Injectable,Capsules,Cream,Ointment and Gel preparation & Packing.
(See Appendix-17)
 2 floor- Assigned for office space,Q.C Laboratory,QA,PD& Microbiology Dept.
nd

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1.1.2 24-hours contact information including incase of Product defects
 Md.Mizanur Rahman-Mobile # 01888814440

General Manager [email protected]
[email protected]
URL-www.ambeepharma.com
 Md.Shabir Hossain- Mobile # 01888814804

Manager Indoor Marketing. [email protected]
[email protected]
URL-www.ambeepharma.com
 Identification number of the site: Post Code -1208
Global-www.ambeepharma.com
1.2 AUTHORISED PHARMACEUTICALS MANUFACTURING ACTIVITIES OF THE SITE:
 Copy of the valid manufacturing authorization issued by the relevant component authority.
Enclosed please find in Appendix-1
 Brief description of manufacturer, import, export, distribution and other activities as

authorized by the relevant authority.
 Manufacturer: Medicine of different dosage form are manufacturing by the AMBEE

Pharmaceuticals under the guideline of WHO’s-GMP regulations.
 AMBEE Pharmaceuticals have authorized License for:(Enclosed please find in Appendix-4)

124- Biological Products.
383- Non-Biological Products.
 AMBEE Pharmaceuticals have GMP Certificate. Enclosed please find in Appendix-2
 AMBEE Pharmaceuticals have ISO Certificate. Enclosed please find in Appendix-3
Materials are imported from different countries:

Import: Not applicable for Medicine, only Raw Materials are imported.
Export: AMBEE Pharmaceuticals authorized to export selective product to Myanmar only.
Enclosed please find in Appendix-5
Distribution: AMBEE Pharmaceuticals have an active and well equipped distribution unit to
provide all our Finished Products even to remote area of Bangladesh as is required.
1.3 ANY OTHER MANUFACTURING ACTIVITIES CARRIED OUT ON THE SITE:

 Not applicable.

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CHAPTER 2
2.0 QUALITY MANAGEMENT SYSTEM:
2.1 THE QUALITY MANAGEMENT SYSTEM OF THE MANUFACTURER :

2.1.1 Brief description of the Quality Management Systems run by the company and reference of the Standards
used:
Our aim is to achieve business excellences through Quality by satisfying customer expectations.
To achieve this objective we follow all National Regulatory requirements & WHO’s good manufacturing
practice (GMP) regulation for Pharmaceutical Operation.
AMBEE Pharmaceuticals ltd. have adequate qualified and experienced including all level trained personnel
to work as team with full dedication and commitment towards quality up grading to maintain Quality
Management System as adopted.
Executive Management is always providing all the necessary resources required for the effective
implementation of Company’s adopted/designed Quality Management System. The Management Review
Meeting are used as the forum to highlight the resource requirement. The source of such requirements are
achieve through critical analysis of:
 Customer Complain (if any)

 Corrective and Preventive Action Plan based on complaint.
 Internal Quality Audit
Including maintenance feedback, training etc.when & where applicable.

The quality System is documented and maintained using Procedures,SOP,Quality Plan,In-Process
Control System etc.The documented results are recorded on forms,format and registers, Log sheet
and reports so that Quality Management System justified consistently.
2.2 RELEASE PROCEDURE OF FINISHED PRODUCTS:

Release of finished product is the last activity in the manufacturing and packing operation at the Factory.
Following points are kept in quarantine until they are released for sale.
 Finished products are kept in quarantine until they are released for sale.
 In-Process Control System are maintained to justify the quality at packaging operation.
 Also, sample of the product taken at certain intervals during packaging operation for QC’s test
and retention purpose.
 Document & record are maintained for a complete audit by QA.
 Through review of all inspection and test including In-Process Control in accordance with quality
plan and documented procedures and that the results meets all pre-determined specification to
complete the evidence of conformance of the finished product for Marketing.Only then QC
release the product for sale.

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 Then Functional Head of Packing Section transfer the product to finished goods store and
accordingly In- charge dispatched the products to National Distribution Centre (NDC) against
their invoice or requirement note.
2.3 MANAGEMENT OF SUPPLIER AND CONTRACTOR:
The organization shall evaluate and select supplier based on their ability to supply product in accordance
with the organization requirement, quality and timing.
The organization shall establish and implement the inspection or verification at supplier’s premises to
justify their activities & environment necessary for ensuring that purchased product meets specified
requirement with all safety measures.
From Classific study suppliers should prepare,review and approve prior to supply any material’s
purchasing documents based on updated specification.
Similarly subcontractor may be established based on:
 Product quality history

 Delivery dependability
 Quality System maintaining Capability.
2.4 QUALITY RISK MANAGEMENT
The organization shall keep vigilance at every step of operation of a product from incoming to end
finished product to overcome all risk level at any stage of operation by:
 Double checking System and

 In-Process Control (IPC) System.
with individual qualified person from related section and documented each step with
Proper record of each operation in BMR and in specific format (Control Document), QC’s
supervision is continuing as In-Process Control System.
If any variation is observed in any operation,then through root cause analyzes, the responsible
authority shall take necessary safety measures immediately.
All activities of AMBEE Pharmaceuticals are guided/originated based on WHO’s-GMP
regulations to justify the risk level to zero defects.

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2.5 PRODUCT QUALITY REVIEWS
Quality Control’s inspection & test facilities are introduced or in action plan from incoming materials
quarantine, dispensing, processing, blistering or any other packing and finally finished goods transferred
to finished Goods Store.
To justify the quality in product(s), as per GMP regulation we archived retention sample for shelf life
study. To review product quality/life QC is carrying routine job of inspection & test on physical, chemical
and stability to identify and justify the rate of deterioration is within acceptable range or not which certify
the product quality as declared for its life time.
CHAPTER 3

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3.0 PERSONNEL
There should be sufficient personnel at all levels with the ability,training,experience and,
where necessary the professional/technical qualifications appropriate to the tasks
assigned to them.
 Please refer to Appendix -8 for Organizational Chart showing the arrangement for quality
management including production & quality control positions.
 Please refer to Appendix-9 for quality management professional personnel including

qualification,expericnces and key responsibilities.
 Please refer to Appendix-12 for number of employees engaged in the quality

management,production,quality control,store and others respectively.
3.1 TRAINING SCHEME: (See Appendix 11)
Ambee Pharmaceuticals Ltd.have yearly training calendar/ plan to build up all employees
through training in the light of GMP to maintain quality management system at any stage of
operation.In this respect all personnel of Production, Quality Control,
Maintenance,Store,Service,Cleaning in word whose duties take them into manufacturing areas or
which bear upon manufacturing activities should receive appropriate training. In service training
are also provided.Trinees acceptance are evaluated following written test & verbal test.
3.2 HEALTH REQUIREMENT OF ALL PERSONNEL WORKING IN FACTORY:
High Standard of hygiene and cleanliness are maintained at emergency and also organization
have yearly medical Checkup programme.A person if seriously ill may be allowed to re-join after
treatment, rest and total fitness.
3.3 PERSONNEL HYGIENE REQUIREMENT INCLUDING CLOTHING:
Suitable wash room and changing areas are available in the Factory for all employees. As safety
measures they are provided official dress/cloth to wear,gloves,shoes,dusk mask, head gear to suit
the operation under GMP guidelines
CHAPTER 4

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4.0 PREMISES AND EQUIPMENT:
4.1 PREMISES:
4.1.1.1 Short description of Plant: Size of the Site and list of buildings and short description of
the Manufacturing area:
AMBEE Pharmaceuticals is preparing both Sterile & Non Sterile products in one pharma
building. Size of production area is 16000sq.ft,which has constructed and maintained with the object of
protecting against the entrance and harboring of vermin,birds,pests and pets.
Premises are designed to have sufficient space to suit the operation with an efficient flow of
work, pipe work, light fittings, ventilation and effective air control facilities including suitable
designed HVAC and AHU system, ETP, air filtration to a sufficient level to prevent
contamination or cross contamination as well as control of temperature and where necessary
humidity appropriate to the product characteristics.
Premises for the packaging of products and storage are specially designed with fittings to avoid
mix-up or cross-contamination, pass boxes are using where applicable for materials flow. We
have separate waste materials dumping area outside the factory.
 Please refer to attached drawing of the plant in Appendix-19

 Layout plan and flow chart are being enclosed in Appendix-17
4.1.1.2 Nature of Construction and Finishes


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Area Nature of Construction

Floor Wall Ceiling Window Door
Tablet Concrete Brick wall with Plastic wood Glass window Glass Door
Floor with enamel paint with Plastic
epoxy paint frame
Capsule Concrete Brick wall with Plastic wood Glass window Glass Door
Floor with enamel paint with Plastic
epoxy paint frame
Injection Concrete Brick wall with Plastic wood …………… Sanduce panel
Floor with enamel paint with Plastic Door
epoxy paint frame
Dispensing Concrete Brick wall with Concrete ceiling …………….. Metal Door
Floor with enamel paint with view
epoxy paint panel
Packaging Concrete Brick wall with Concrete ceiling ……………… Metal Door
Floor with enamel paint with view
epoxy paint panel
Liquid Concrete Brick wall with Concrete ceiling Glass window Glass Door
Floor with enamel paint
epoxy paint
4.1.2 BRIEF DESCRIPTION OF HEATING, VENTILATION AND AIR CONDITIONING (HVAC)

SYSTEM. (See Appendix 18)
The Air Handling Unit(AHU) is the main component of HVAC system to provide the intended
quality of air to the designed production area & corridor are or where applicable.
The production area is effectively ventilated with suitable designed AC& HVAC system. Air
supply to the sterile or desired area is filtered to minimize the potential contamination by viable or
non-viable particulate matter. HEPA filters are used at terminal point of blower and at Laminar
Flows hood to filter the air. The system is provided with Air Handling Unit with returned or re-
circulated air, having percentage of fresh air added. Recirculation of air system reduced the risk to
zero level of contamination.
Thus to ensure the cooling as per HVAC system the Air-conditioning Unit will act to cool down
the temperature to a desired level so that it can assure provide the intended room
temperature,humidity,air flow air pressure and air cleanliness.
The HVAC system in the sterile products manufacturing shoule address minimum Temperature
230 ± 20c,Relative humidity 45% ± 5% and Air velocity normally required in between 80-120 feet
per minute.
Classification of Clean area:
 Clean room- 10,000 class where air changes rate is more than 20
 Manufacturing of sterile product :
Room under 100 class is A-Grade
Room plus 100 class is B-Grade

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Recommended air velocity for vertical & horizontal laminar flows are 0.3 meter /second and
0.45 meters /second respectively. Heap filtered are monitored periodically by the test of:
 Air velocity
 Pressure drops across HEPA filters
 Checking integrity using cold Dop (Dicoctyl Phthalate) and
 Air Direction.
Hepa filter needs to change if velocity drops below the acceptable criteria. Frequency of test may
be quarterly.
Also the integrity of HEPA filters are checked by scanning the filter surface using particle
Counter or a cold Dop (Dioctyl Phthalate). Filters are changed based on following Observation:
 Air sampled at the filter surfaces if exceeds 100 particle per cubic feet per minute or 0.003%
penetration of DOP smoke.
 Damage to the filter media if above 5% of total area.
 Leakage is observed at the seal in between filter media and frame.
 The velocity of air is changes in the room if less than 20 per hour.
 A pressure differential is greater than 2 inches water gauge.
4.1.3 BRIEF DESCRIPTION OF EFFLUENT TREATMENT PLANT (ETP)
The pharmaceutical industry generates lots of waste water during the production or formulation
of medicines. So it is very important to convert the waste water into good water. So Effluent
treatment plant technology is used to removes such waste water. Water purification technology
uses to remove solids from liquids.
STAGES INVOLVE IN EFFLUENT TREATMENT PLANT (ETP)

 Screening Chamber
 Oil & Grease Trap
 Equalization Tank
 Flush Mixer Tank
 Flocculation Tank
 Primary Clarifier
 PH Controller
 Aeration/ Biological Treatment
 Secondary Clarifier
 Sludge Tank
 Sludge Drying bed
 Carbon Filter
 Micron Filter
COLLECTION OF WASTE WATER:


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The collection tank collects the effluent water from the screening chamber, stores and then pumps it to the
equalization tank.
SCREENING CHAMBER:
The screen shall be fitted 45 to 60 degrees to the vertical is desired. The screen shall be at the right angle to the
direction of flow. Screen used to remove large size particle size, cloth and plastics screen size used of 10 mm.
OIL & GREASE TRAP:
It is necessary to remove oil or grease that comes through lubrication, boiler, cooling tower, blowdown of the
boiler. T-Pipe and gutter are used to avoid floating grease or oil. Then it is necessary to remove from the top of the
water and collected it in the waste drum. Then it should be sent to further disposal and treatment.
EQUALIZATION TANK:
The effluents do not have similar concentrations at all the time; the pH will vary time to time.
Effluents are stored from 8 to 12 hours in the equalization tank resulting in a homogenous subsequent
treatment system. Continuous mixing also eliminates settling of solids within the mixing of effluents and
helping in neutralization. It eliminates shock loading on the equalization tank. Then reduces SS, TSS
FLOCCULATION TANK:
A flocculation tank is used in the Effluent treatment plant to dissolves the colloidal solid. These are solid, and
their size is in between less than suspended solid and greater than dissolved solids
PH CONTROLLER:
To adjust the pH in the treatment process to make wastewater pH neutral.

For acidic wastes (low pH): NaOH, Na2CO3, CaCO3or Ca(OH)2.
For alkali wastes (high pH): H2SO4, HCl.
AERATION /BIOLOGICAL TREATMENT:
Aeration is provided to the tank with an aerator or agitator. This technique is important for trickling filters,
oxidation pond, aerated lagoons, activated sludge, bio-disc, bio bulb, etc.
SECONDARY CLARIFIER:
Once the completion of aeration, micro-organism has utilized the biological oxygen demand as food and is grown
and multiplied A problem arises if the Biomass remains mixed in liquor, these access layers are removed from the
tank to the alternative sludge bed to dry the sludge and use as soil for land feeling. Maintained 20-30% Sludge to
water.
SLUDGE TANK & SLUDGE DRYING BED:


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Primary and secondary sludge is dried on the drying beds. Sludge settled in clarifier is removed in these beds and
dried and used for landfill.
CARBON FILTER & MICRON FILTER:
Activated Carbon Filters for the use in tertiary treated water for removing of color and odor. Our carbon filters are
designed to work on high flow rates, thus reducing the in line pressure loss.Micron Filter is used to filter the
particles below 30-50 micron.Filtration units generally operate most effectively and economically on applications
having contamination levels of less than 50 ppm
 Please refer to Appendix - 20 Diagram of Effluent Treatment Plant (ETP)
4.1.4 BRIEF DESCRIPTION OF WATER SYSTEMS
Water production storage and distribution system are efficiently designed and maintained to ensure the
reliable production of water of an appropriate quality that prevents and free from microbial or physical
contamination.
Water source are monitored regularly for quality and for chemical microbiological or for endotoxin
contamination.
Drinking water: Drinking water is unmodified except for limited treatment of the water derived from a
natural or stored source. At AMBEE Pharmaceuticals the source of water is its own Deep Tube
well .The water is treated to render it safe for human consumption. The treatment includes softening,
removal of specification, particle reduction and antimicrobial treatment. Necessary tests are carried at
least from three (3) different points.
Purified water: Source of Raw water is Deep tube well which contains all water soluble
minerals .AMBEE Pharmaceuticals maintain a DM plant to remove mineral salt from raw water by ion-
exchange process. After demineralization the water passes through the fine RO filter so that the
processed water meet all the specification of Pharmaceutical Grade Purified water as is recommended by
WHO and leader Pharmacopoeia of the world.
Water for Injection : Collect freshly Prepared DM water to clean surge water feed tank of multicolumn
to feed back operation as per SOP to get safe WFI .First few liters to be discarded, then advice Q.C
department using format IN-PROCESS TEST QC/3/003 to collect sample for test the qualifying
parameters of WFI. On getting approval from QC continue WFI preparation and send through safe &
clean pipe to clean reserve tank of injectable process area. Temperature of WFI may have ± 80°c, allow
to down sufficiently for processing.
FACILITIES REQUIREMENT FOR WATER PREPARATION:


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Water type Capacity Construction Materials Specification of filters in the System

(Produced) of Vessel & Pipe Work
Purified Water 500L/hour S.S. Grade 316 Cartridge filter 0.1&0.2 micron
Membrane Type: Thin film composite.
Maximum Operating Pressure: 600 psi
Water For 500/hour S.S. Grade 316
Injection
(WFI)
SPECIFICATION OF WATER PRODUCED:
SR.NO PARAMETERS PURIFIED WATER WATER FOR INJECTION

1 Appearance Clear & Colorless Liquid Clear & Colorless Liquid
2 PH 5.0 ̴7.0 5.0 ̴7.0
3 Oxidizable Substances To Comply BP To Comply BP
4 Chlorides To Comply BP To Comply BP
5 Sulfate To Comply BP To Comply BP
6 Calcium & Magnesium To Comply BP To Comply BP
7 Nitrates Maximum 0.2 ppm Maximum 0.2 ppm
8 Heavy Metal Maximum 0.1 ppm Maximum 0.1 ppm
9 Conductivity Not more than 1.3 µs/cm² Not more than 1.3 µs/cm² at 20°c
10 Residue on Maximum 0.001% Maximum 0.001%
Evaporation
11 Microbial Not more than 100 (a) Bacteria: 10CFU/ml
Contamination microorganism-nism/ml (b) Fungi: Nil
12 Bacterial Endotoxins ---------- Less than 0.25 EU/ml
N.B. Schematic drawing of the system. Please refer to Appendix –19
4.1.5 Brief description of other relevant utilities such as steam, compressed air, Nitrogen etc.
To facilitate the manufacturing on the site the other activities in operation are:
● AC facilities (Both ground & 1st floor and 2 nd Floor) -120 Ton capacity
● PDB is the main supplier of electricity but alternative source is stand by for emergency
self 500 KVA
● Steam Generator, Organization have - 2 Ton Boiler
● Source of water Facilities -Self deep tube well
● HVAC System: Operation for Injectable product preparation area.
● Compressed Air: Organization has sufficient 10 Bar Air compressors to supply compressed air to
feed back the production unit including coating, blister stripping and when &
where applicable.

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● Nitrogen gas: Nitrogen gas is using as product protecting utilities in Injectable product
processing and filling operation. Supplier of Nitrogen gas in cylinder is LINDE
Bangladesh Ltd.
● Natural Gas: Supplier Titas gas Bangladesh Ltd for sealing filled ampoule only.
AMBEE Pharmaceuticals have well equipped maintenance work shop and a group of skilled work
personnel are working for any sorts of repairing or servicing to keep production running
4.2 EQUIPMENTS
Basic concept that the equipment should be designed located and maintained to suit the processes and
products for which it is to be used. The factory of AMBEE Pharmaceuticals is equipped with adequate
numbers of most updated production and laboratory machinery and equipment made of stainless steel,
Grade 316 and installed in the suitable places with all safety measures for easy operation.
Please refer to Appendix 8 for list of production and Laboratory equipment in separate Sheet.
All machinery and equipment are designed in such that it can be easily and conveniently cleanable both
in and outside as per SOP to ensure cleanliness. Prior to each use cleanliness must be checked.
As per GMP regulation equipment should be maintained and located at a distance sufficient from other
equipment to avoid embarrassing and confusing situation.
AMBEE Pharmaceuticals is taking the advantage of computer science using Enterprise Resource Plan
(ERP) in regular Inventory Control System, communication and data preservation and so many.
4.3 QUALIFICATION, VALIDATION AND CALIBRATION
 For each activity, whether qualification or validation, an approved protocol is used, stating how
the work shall be conducted. Methods to be followed, data to be generated & acceptance criteria
are to be stated. Installation Qualification (IQ), Operational Qualification (OQ) and Performance
Qualification (PQ) are conducted. The Qualified systems are monitored as per the respective
procedure.
 The need for revalidation is determined by an annual review by Quality Assurance. It covers
manufacturing/analytical data, changes made to equipment, facilities & processes and responses
to the changes in regulations.
 Initial Process Validation batches are produced to establish any necessary change in processing
(e.g. from planetary mixer to high speed mixer-granulator). A report is prepared on the basis of
process validation findings which were taken care during preparation of PV protocol.
 After completion of successful process validation, PV batches are released.
 Engineering Department is responsible for all calibration activities on site. Comprehensive
records are maintained for all instruments enquiring calibration. Instruments have stickers
attached stating when they were calibrated and what‟s the next date of calibration. Instruments
used to perform calibration are certified on an annual basis and are traceable to national standards.

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Most of the reference instruments are certified externally by the suppliers due to the absence of
such facilities in Bangladesh.
 The list of equipment qualification team is shown in APPENDIX-1

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CHAPTER 5
5.0 DOCUMENTATION
5.1 Preparation, Revision and Distribution of Document:

5.1.1 Preparation
Any Document specific to a department will be prepared by the respective department. Other quality
documents will be generated by QA Department.
5.1.2 Revision
All documents such as Standard Operating Procedures, Batch Production and Control Records,
Master Formulas, Standard Test Procedures, Specifications etc. are reviewed and approved by the
QA department before use. Any changes to be made in these controlled documents have to be
justified and approved by QA Department.
A Change Control Procedure is followed for any change in manufacturing procedures/practices,
change in vendors, equipment etc. are implemented after approval by the Quality Assurance
Department. Issuance and withdrawal of SOPs is controlled by the Quality Assurance Department.
SOPs are reviewed after two years, and if no change is required same is revalidated for next two
years. In case of change, SOP with next revision number is issued and old SOP is withdrawn and is
stamped as “Obsolete”.
Quality Assurance Department carries out the distribution of the documents. Exceptions are
specified and Analytical Test Procedure, which remain with Quality Control Department.
Each copy is numbered and controlled. Superseded documents are withdrawn. Batch documents are
computer-generated/ photo copies of the master copy.
5.1.3 Distribution
User department sends a written request for issuing the Batch Manufacturing Record to Quality
Assurance Department.
The QA department shall photocopy required number of documents from the master/ original copy.
On first page “ISSUED BY” column is placed and signed and dated by the QA Manager or his
nominee.
The particulars are entered in the issuance register and the documents are handed over to user
department.

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5.1.4 Storage
The QA Manager is responsible for revision and distribution of documents. The master documents
are stored in QA Department.
After the completion of manufacturing, Batch Manufacturing Record, Testing Records are submitted
to the QA department for review. The documents are stored in the QA Department.
The batch documents are kept for at least one year after the expiry of the product. The testing records
of raw materials are retained for 5 years. All documentation is retained as hard copy only. No
electronic or microfilmed copies are used.
5.2 Other documentation related to product quality:-
 Product specification and test procedures
 Raw material specification and test procedures
 Master production and control records
 Batch Manufacturing Records
 Standard Operating Procedures
 Equipment usage records
 Area and equipment cleaning records
 Training documents
 Inventory, issuance records
 Calibration records
 Preventive maintenance records
 Validation protocols (DQ, IQ, OQ, PQ, PV etc.)
 Distribution record
5.3 Document Review Committee (See Appendix 16)
The purpose of this committee is to identify the requirement of documents and to review
the documents.
Document Review Committee is comprised of members of Interacting Department and Head
of Quality Assurance plays a role as a leader.
The document Review Committee is performed the following activities:
Head of Quality Assurance:

 To determine whether the documentation falls under the scope of the committee.
 To communicate with the committee members.
 To provide the timeframe.
 To keep the committee review record updated.
Document Review Committee Members:

 To review the documents.
 To ensure quality assurance for regulatory compliance.
 To ensure clear positioning of major messages.
 To do a final edit for accuracy, cross-references and consistency.

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CHAPTER 6
6.0 PRODUCTION
6.1 TYPE OF PRODUCTS:
 In short about quality products:
In AMBEE Pharmaceuticals quality products are manufacturing consistently. The quality of product
is strongly related to and influenced by its design, test, and produce dosage forms that provided to
the customer is with quality, purity, uniformity of content , stability, safety and physiological
availability.
To facilitate the quality in product we follow World Health Organization’s GMP guideline which is
governing various phases of personnel, equipment, building, control records and production
procedure under proper planning & control. Also strict environmental condition including
Temperature, Humidity and cleanliness are maintained as specified in Batch Manufacturing record
(BMR) of individual product.
All type of production equipments are available in AMBEE Pharmaceuticals for the preparation of
different dosage forms, namely:- Please refer to Appendix-21.
 Solid dosage form

 Liquid dosage form
 Semi-solid dosage form (Cream, ointment & gel)
 Encapsulation
 Injectable Products
 Penicillin & cephalosporin (Program deal under contractual manufacturing)
 List of dosage forms of human products which are manufacturing on the site, Please refer to Appendix 4.
 For Veterinary Products: Not applicable.
 For investigational medicinal products: Market Research team is working for new molecule
investigation.
 For toxic and hazardous substances handled (e.g. With high pharmacological activity or with sensitizing
properties)
All toxic and hazardous sensitizing materials handled carefully and stored in safe room under
conditioned as is designed and recommended by the WHO’s guideline. Also as safety measures Liquid
form materials or organic solvent are stored out side the product operational premises under close
system and dispense carefully in need.

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Sensitizing dosage forms like capsules and dry powder for suspension have separate manufacturing area
and facilities using different machinery and equipment under control Quality Management System.
Starting from storage, changing clothes dispensing, processing, packaging, sanitation etc. are performed
separately. Air Handling Unit (AHU) are used. Pipe work, Valves and vent filters are properly designed
to facilitate to validation cleaning and decontamination .Premises are provided with sufficient space for
the operation to be carried allowing an efficient flow of work and effective communication and
supervision.
 Product types manufactured in a dedicated facility or on a campaign basis, if applicable:-Not Applicable
 PAT applications, if applicable: general statement of the relevant technology and associated
computerized system.
- Not applicable, only ERP system is applied to feed back the Inventory control and production.
6.2 PROCESS VALIDATION. (List of Process Validation Team, See Appendix-14)
6.2.1 BRIEF DESCRIPTION OF GENERAL POLICY FOR PROCESS VALIDATION:
 Process validation is documented assurance that the system under investigation satisfies its intended
purpose ie. ensuring and providing documentary evidence that proceses are capable to produce
consistently finished product of the required quality.
 Objective:
The process validation guideline is intended to assist the manufacturer in understanding quality
management system (QMS) and to ensure that the process applied for product preparation is constantly
produces product meeting its predetermined requirement.
 Scope:
Guideline is intended to perform product preparation using validated clean equipment and area.
Manufacturer of the three(3) consecutive finished products will study and evaluate the data justify the
validation of the process. In word specific recommendation for verification of design output and design
validation is included in the document covering design control.
 Procedure :
Manufacture three (3) consecutive batch of any product using same procedure and equipment and
maintaining same environmental condition. QC test must be carried according to design control or
compendium requirement. Keep all record and data in process sheet or relevant format to review and
justify the process validation.

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 Prepare process Validation report:
These include for each validation run; date study initiated, date completed, observation made, problems
encountered, completeness of information collected. It is thus conducted in the context of a system
including design and development control, quality assurance, process control and corrective and
preventive action plan.
6.2.2 POLICY FOR REPROCESSING OR REWORKING:
If needed any product may be reprocessed with the approval of Head of QA/QC if it is justified through
review that the product after reprocessing will meet all its criteria. Then BMR and all other related
documents may be prepared or revised for reprocessing. After reprocessing QC will conduct sampling &
test, on satisfactory results QC may released the product for sale.

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CHAPTER 7
7.0 MATERIAL MANAGEMENT AND WAREHOUSING:
7.1 Arrangement for the handling of starting materials, packaging materials, bulk and finished
products including sampling, quarantine, release and storage.
The main objective of the Pharmaceuticals manufacturing operation is to produce quality product at the
end using active and inactive materials and various packaging materials. Handling of starting materials
from incoming to end finished products are summarized as:
 All incoming materials are received as per invoice /challan and store in quarantine area for inspection
and sampling for test and conformance with established specification and are released by Head of
QA/QC In-charge for use.
Initially representative of QC labeled the container with yellow coloured UNDER TEST tag and on
approval a green coloured PASSED tag affixed on container.
 All approved materials (RM & PM) to be used in manufacturing /processing and packing are to be stored
in the designated area, Must be handled and dispensed in a safe and orderly manner following the
principle of first in first out (FIFO) system of GMP regulation with adequate precautions in every step to
prevent deterioration, mix-up, spillage or breakage and cross-contamination that affect drugs or drug
products.
 In AMBEE Pharmaceuticals special environmental condition are maintaining for certain materials and
products.
Starting from the receipt of raw materials till bulk goods are ready for packing into their primary
and finished packs all stage checking and maintaining environmental condition as are cleanliness
of equipment and working area as per SOP, room temperature, humidity, pressure difference,
class of air etc. and these are recorded in prescribed format.
 Packed finished products are stored in designated quarantine area until QC Department through review
and test release the product for sale. Then using Transfer Note functional head transfer the product to
Finished Goods Store.
 All stage works should be done according to relevant SOP BMR and documented record should be
maintained in designed format or in In-Process control Sheet to justify the activity at requirement.

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 As safety measures ,major precaution are taken to protect materials (RM&PM)from infestation of :
- Rats, mice and other vermin
- Flies, cockroaches, water bugs and other insects.
7.2 ARRANGEMENT FOR THE HANDLING OF REJECTED MATERIALS AND PRODUCTS
When at any stage ,the materials or products have been tested against a set of predefined
specification and found the results not meeting specification then it must be called REJECTED
and Stored in the isolated and segregated area with a red coloured REJECTED Label on the
product or materials and finished products to be destroyed for the following reason:
 Date expired raw materials, not suitable for further use.

 Out dated and obsolete primary or printed packing materials.
 Date expired finished products returned from market or depots to the Factory.
 Damage products returned from markets which are not refurbisable.
 Recovered materials from production or any processing which are not suitable for rework.
 Date expired retention shelf-life sample.
Materials or products which have been rejected, recalled or returned must be labeled with red
coloured REJECTED Tag for easy identification and traceability, date and product information
status slip and with authorization/authenticated signature of QA/QC Departmental Officer .Then
placed or stored the defective materials/products in a safe and segregated area to avoid confusion
or mix-up with other materials or products until destruction work is completed.
 We are also taking the advantage of SOFTWARE services for Data Base Inventory Management
of materials and products.

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CHAPTER 8
8.0 QUALITY CONTROL :
8.1 Description of the QC activities carried out on the site in terms of Physical, Chemical and
Microbiological and Biological Testing.
8.1.1 In brief description of the activities of QA/QC

Quality Control is a part of GMP concerned. The major responsibilities of QC include: Set up
specification, inspection, sampling and analysis of Raw Materials and processing intermediates
and of all final products manufactured and approved for commercial sale.
Also, responsible for documentation and record of each action plan and release procedures which
ensure that the necessary and relevant test are carried out and any materials or product is not
released for use if it does not meet its predetermined specification.
AMBEE Pharmaceuticals have a independent Quality Control Department with adequate facilities
and trained personnel having qualification M.Pharm, M.Sc in
Chemistry/Bio-Chemistry/Microbiology. Test facilities covering relevant SOP, approved
procedure for sampling, inspection and analysis of starting materials and packaging materials.
Also,intermediate,bulk and finished products including environmental condition as per GMP
regulation are maintaining under In-Process Control System to avoid mix-up, contamination,
labeling mistake etc, to built quality in products consistently.
8.1.2 FACILITIES IN QC LABORATORY ARE:
In AMBEE Pharmaceuticals the QC Laboratory has the facilities:

 Chemical Testing Laboratory Supported with chemicals, necessary glass equipment and reagents stores.
 Instrumental analytical Laboratory with all required instrument like HPLC, AAS, Spectrophotometer,
KF Titrator,FTIR etc.
 Microbiological Laboratory with required culture media, organism, and incubators etc, along with
specially designed Laboratory for sterility testing, microbiological assays and limit test etc.
Please refer to Appendix-16 for List of Microbiological Laboratory equipment.
 Provision for retained sample, stability test sample etc.
 Proper documentation and record keeping system.
 Various books like Pharmacopoeias, Analytical Chemistry, Microbiology etc and so many other books
related to materials.
Please refer to Appendix-15 for List of Laboratory equipment.
Please refer to Appendix-17 for List of Product Development Department equipment.

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8.1.3 HEAD OF QA/QC AND CONCERNED QUALIFIED PERSONNEL ARE CONSCIOUS

ABOUT ANALYSIS AND TESTING IN THE FIELD OF:
 Active and inactive ingredients (Raw Materials)

 Primary, Secondary and other packaging materials.
 Weighing materials at dispensing and issue of packing materials.
 In-Process Control System.
 Finished bulk and packed products.
 All in-coming materials are placed in Quarantine area after inspection and sampling a yellow
coloured QUARANTINE Label affixed on each container.
 Approved materials are labeled with a green coloured PASSED Label where disqualified materials
are label with red coloured REJECTED Label and kept in separated segregated area for next step
action plan.
8.2 PHYSICAL, CHEMICAL, MICROBIOLOGICAL AND BIOLOGICAL SCOPE OF TESTING

IN THE FIELD OF:
 Physical and Chemical test are summarized as :

Test recommended for appearance, color, ordor, identity, optical rotation, specific gravity, pH,
solubility, viscosity, average weight or volume per unit, weight or volume variation, content
uniformity, moisture content and assay for active ingredient(s), impurities or degradation products.
 Biological and Microbiological Tests:

Microbiological assays and tests for safety, toxicity, pyrogenicity, sterilicity, histamine, antiseptic
activity etc. are normally carried out in the well equipped Microbiological Laboratory of AMBEE
Pharmaceuticals.
8.3 RELEASE OF FINISHED PRODUCTS
Head of QA/QC has the authority to release the product after reviewing the document and records to
assure the correct compliance of:
 Manufacturing and packaging order

 QA/QC records including In-Process Control records.
 The actual yield obtained.
8.4 SHORT DESCRIPTION OF QUALITY ASSURANCE

 QA is the sum total of the organized arrangement with the main purpose to ensure that the characteristics
of the finished dosage form conform to appropriate standards of identity,purity,potency,quality,safety
and efficacy.

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 And the products of any dosage form are consistently produced and controlled as per Specification and
pre set up standard under Good Manufacturing Practice (GMP) regulation.
 Several types of activities done by Quality Assurance to achieve objective and to build quality in
Products. It is thus concerned with both Manufacturing and Quality Control Procedures.
8.5 OTHER ACTIVITIES
 In AMBEE Pharmaceuticals expansion plan of Quality Assurance and Quality Control including Product
Development section under construction in the second floor of the existing Factory building.
 CONTRACT MANUFACTURE AND ANALYSIS

AMBEE Pharmaceuticals Ltd is in advance about manufacturing Penicillin & Cephalosporin products on
contact basis under the regulation of toll manufacturing with APEX Pharmaceuticals Ltd.

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CHAPTER 9
9.0 DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALL
9.1 DISTRIBUTION (TO THE PART UNDER THE RESPONSIBILITY OF THE

MANUFACTURER)
9.1.1 TYPES AND LOCATION (REGIONAL ECONOMIC AREA) OF THE COMPANIES TO WHICH
THE PRODUCT ARE SHIPPED FROM THE SITE
After completed the packing the products are kept in quarantine area. Through inspection and
review QA/QC released the product(s) considering the following points:
 Completed Batch Packing Records.

 Verification of the In-Process Control records.
 Test report of finished product analysis.
 In case of sterile product necessary test and environmental condition report.
Based on RELEASED FOR SALE the product(s) transferred from quarantine area through Transfer
Note to Finished Goods Store. Store Personnel are maintaining record in ledger and in computer
ERP System. In AMBEE Pharmaceuticals as per invoice the finished products are transferred to
their National Distribution Cell (NDC)
In every step documentation and records are maintaining as is recommended.
9.1.2 DESCRIPTION OF THE SYSTEM USED TO VERIFY THAT EACH CUSTOMER/RECIPIENT

IS LEGALLY ENTITLED TO RECEIVE MEDICINAL PRODUCT FROM THE
MANUFACTURER.
AMBEE Pharmaceuticals Ltd. Organizes quite a good number of Depot Office to supply the
finished products for the customer satisfaction to the retail shop keeper having medicinal
product sale authorization or legally entitled to receive medicinal product to sale.
9.1.3 BRIEF DESCRIPTION OF THE SYSTEM TO ENSURE APPROPRIATE ENVIRONMENTAL

CONDITIONS DURING TRANSIT E.G. TEMPERATURE MONITORING CONTROL.
To ensure quality product environmental conditions are maintained to meet the processing
requirement e.g. temperature, relative humidity, pressure difference, class of air etc, to achieve
quality product and steps of operation are recorded in prescribed format.
AMBEE Pharmaceuticals Ltd authorized persons are very careful in product transportation both
inside and outside the factory with necessary safety measures to ensure that

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 The identification product is not lost.

 No confusion arises between a consignment which is suitable for use and other consignment of the same
product which are not
 Precaution to avoid product contamination with one another.
 Adequate precautions are taken against spillage or breakage.
 During transportation or storage precautions are taken so that the product and its pack are not
unacceptable due to degree of heat, cold, light, moisture or other adverse influence not to attack by
micro-organism or pests.
9.1.4 ARRANGEMENT FOR PRODUCT DISTRIBUTION AND METHOD BY WHICH PRODUCT

TRACEABILITY IS MAINTAINED.
Following invoice finished goods are transferred from Factory to NDC.Similarly the products are
transferred from NDC to Depot Office as per their invoice. Then Depot Office are prepare a
delivery schedule for retail shop keeper to reach the product to customer or user end and executed
schedule in time.
9.1.5 MEASURES TAKEN TO PREVENT MANUFACTURER’S PRODUCT TENDING INTO THE

ILLEGAL SUPPLY CHAIN.
Not applicable, through NDC & Depot Office the products are supplied to only authorize license
holder retail shop keeper for distribution to customer.
In every step documentation and records are maintaining as is recommended.
9.2 COMPLAINT, PRODUCT DEFECTS AND RECALLS
9.2.1 BRIEF DESCRIPTION OF THE SYSTEM FOR HANDLING COMPLAINT, PRODUCT

DEFECTS AND RECALLS
A complaint may originate from consumer, physician, chemist, retailer, hospital institution or
whole seller/warehouse.
Complaint classified to facilitate investigation in following categories:

 Product quality complaint
 Packing Complaints
 Medical Complaint
If any complaint arises from user end or any corner then through sales unit of area Depot Office
the Complain as per AMBEE Pharmaceuticals System should forwarded to indore Marketing and
Export (IM & E) Division for review and next step action plan. Functional Head or Manager IM
& E circulate the complain using Correctives and Preventive Action Plan (CPA)to the relevant
authority and called a meeting to review and select a investigation committee for root cause

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analysis to find out the immediate corrective action and safety measures through preventive action
plan to stop such complain in future. Committee members are Head of QA/QC, Production, R&
D, Manager IM& E and any appropriate functional head. Subject to nature of compliant the
investigator investigate the complaint by referring to the Batch Manufacturing record (BMR),
SOP, Machine Log sheet /register, Retention sample,Reconcillation of materials, Storage
condition used and then prepare the product complain report and approved by Head QA/QC.
In case of medical complaint, If Head of QA/QC, Regulatory and Medical Advisor feel that the
product will put the public to risk, they may be advised to recall the product immediately.
In each step necessary document and records to be maintained for future reference.
9.2.2 PRODUCT DEFECTS
If The complain is minor defect in product and arises from one or limited area then with the
consultation of investigation team the complaint may be minimized by replacement of the product
with a good one from other lot just to keep continuation of business. In case of severe/major
complaint or defects in product or damage the relevant authority of the investigation team may be
recommended to recall the product from the market immediately.
9.2.3 RECALL PRODUCT
The complaint product need to recall from the market based on following situation:
 Identified sub-standard after distribution

 Reported adverse effect
 Instructed by regulatory authority
 Wrong/defective packaging
Based on investigation committee report of Recall Products the Factory will appoint a person as
Recall Coordinators from the senior management staff. Under his guidance all recall activities to
be initiated with document and records of distribution to facilitate the effective recall.
 The documents will have the following information
1. Name of the Product, Strength, Pack-size, batch number, Mfg date and Exp date.
2. The total number of units released for sale
3. The date of distribution and quantity.
 The Recall Coordinator will set a time frame for recall the product from all sources.
 Accountability should be maintained after Recall date is over and will submit a report to Head of
Operation and Head of QA

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 The Recalled Product will be stored in the Factory in a secured area with NON CONFORMING label
until the disposition decision is taken and action takes place.
 The recovered samples as well as retention sample tested.
 All document and records relevant to product recalled will be reviewed and for disposition or destruction
a report should be prepared and submit to Managing Director for approval.
 On getting approval Head of QA and Head of Operation will prepare a team with one member each from
Administration Department, Accounts, Senior level Officer of Production, QA or QC for destruction the
recalled product in short time.
 Document & records of every action plan will be maintained.


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CHAPTER 10
10.0 SELF INSPECTION
10.1 SHORT DESCRIPTION OF THE SELF INSPECTION SYSTEM
Self inspection is the key activity of Quality Assurance. Check list is the instrument to verify the
complaince to GMP, to evaluate the procedures and to assess the physical state of the premises,
machinery & equipment and other parameters in a systemic manner.
A proper check list covering all aspects of pharmaceutical manufacturing activities in performing
the job systematically and efficiently.
10.2 CRITERIA USED FOR SELECTION OF THE AREA TO BE COVERED DURING PLANNED
INSPECTION AND PRACTICAL ARRANGEMENT.
The self-inspection list is developed to ensure GMP in the premises as per WHO’S requirement
which cover the following areas:
 Personnel
 Premises and Personnel facilities
 Maintenance of building & equipment
 Storage of starting materials and finished products
 Production and In-Process control system & records
 Quality Control system
 Documentation
 Sanitation and hygiene
 Validation and revalidation programs
 Calibration of Machinery & equipment
 Recall procedures
 Label Control for traceability & identification
 Review of Previous self inspection report and corrective action plan
10.2.1 SELF –INSPECTION TEAM (List of Self-Inspection Team, See Appendix-13)
A self-inspection team are to be formed with the qualified member from different discipline
such as QA, QC, Production, Engineering (Maintenance), Warehousing etc with sufficient
knowledge of GMP regulation.

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10.3 ARRANGEMENT AND FOLLOW UP ACTIVITIES
Self-inspection plan should be implemented once in a year or when required at short interval.
Conduct the self-inspection as per following check list and prepare a report after completion of
the inspection
The report Consist of:

 Observation made by the team member (audit team)
 Evaluation and conclusion draw
 Recommendation for corrective action
The inspection report should be submitted to Head of Operation or General Manager of the
Factory to review with management for corrective action on the deficiencies found at inspection.
Follow up inspection activities shall be verified and record the implementation and effectiveness
of the corrective action taken.

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AMBEE PHARMACEUTICALS LTD.

184/1 TEJGAON INDUSTRIAL AREA, DHAKA-1208

Document No. Effective Date Review Date

SITE MASTER FILE

Document No. Effective Date Review Date

Name Designation Signature Date

Prepared By Mahabub Hasan Asst. Production Manager

Md Abdus Sobhan Senior Production Officer

Md.Al Mujahidee Asst. Quality Assurance

Approved By Abdur Razzak Asst. Quality Control

Somraj Debnath Asst. Manager Engineer

Reviewed By S.P. Barua Heat of Operation

Document No. Effective Date Review Date

Document No. Effective Date Review Date

5.2 Other Documentation Related to Product Quality

9.1.3 Brief Description Of The System To Ensure Appropriate Environmental

Document No. Effective Date Review Date

10.1 Short Description of the Self Inspection System

Document No. Effective Date Review Date

APPENDIX-2 GMP Certificate

Document No. Effective Date Review Date

1.0 GENERAL INFORMATION

Document No. Effective Date Review Date

1.1 GENERAL INFORMATION OF THE MANUFACTURER:

1.1.1.1 Brief Description of the manufacturer:

1.1.1.2 Name and address of the Manufacturer: AMBEE Pharmaceuticals Ltd.

Document No. Effective Date Review Date

1.1.2 24-hours contact information including incase of Product defects

 Md.Mizanur Rahman-Mobile # 01888814440

 Md.Shabir Hossain- Mobile # 01888814804

1.2 AUTHORISED PHARMACEUTICALS MANUFACTURING ACTIVITIES OF THE SITE:

 Brief description of manufacturer, import, export, distribution and other activities as

 Manufacturer: Medicine of different dosage form are manufacturing by the AMBEE

 AMBEE Pharmaceuticals have authorized License for:(Enclosed please find in Appendix-4)

Materials are imported from different countries:

1.3 ANY OTHER MANUFACTURING ACTIVITIES CARRIED OUT ON THE SITE:

Document No. Effective Date Review Date

2.1 THE QUALITY MANAGEMENT SYSTEM OF THE MANUFACTURER :

 Customer Complain (if any)

Including maintenance feedback, training etc.when & where applicable.

2.2 RELEASE PROCEDURE OF FINISHED PRODUCTS:

Document No. Effective Date Review Date

2.3 MANAGEMENT OF SUPPLIER AND CONTRACTOR:

Similarly subcontractor may be established based on:

 Product quality history

2.4 QUALITY RISK MANAGEMENT

 Double checking System and

Document No. Effective Date Review Date

2.5 PRODUCT QUALITY REVIEWS

Document No. Effective Date Review Date

 Please refer to Appendix-9 for quality management professional personnel including

 Please refer to Appendix-12 for number of employees engaged in the quality

3.1 TRAINING SCHEME: (See Appendix 11)

3.2 HEALTH REQUIREMENT OF ALL PERSONNEL WORKING IN FACTORY:

3.3 PERSONNEL HYGIENE REQUIREMENT INCLUDING CLOTHING:

Document No. Effective Date Review Date

4.0 PREMISES AND EQUIPMENT:

 Please refer to attached drawing of the plant in Appendix-19

4.1.1.2 Nature of Construction and Finishes

Document No. Effective Date Review Date

Area Nature of Construction

4.1.2 BRIEF DESCRIPTION OF HEATING, VENTILATION AND AIR CONDITIONING (HVAC)