GOOD DOCUMENTATION PRACTICE

One of the way to be excellent…

By : Hardik Mistry, Exe.
Q.A.

QUALITY SQUARE INDUSTRY

Good documentation constitutes an essential part
of the Quality Assurance system.

Schedule M : Good Manufacturing practices, 12 : Documentation and records

EU GMP – Chapter 4: Documentation
 Contents
 What is Good Documentation Practice (GDP) ?
 Purpose of Good Documentation Practices ?
 Standards of the GDP
 Types of the Documents
 Typical elements of the Document
 Common Documentation Errors
 How to acquire good documentation practice ?
 Benefits of the GDP
General philosophy of any Quality System

Say What you do?

Do what you say ?
Prove what you say and do
 What is Documentation ?
To Document each Activity you perform

No, Documentation is a Process, Which comprises of Following :

- Recording of Data
- Approval of Documents
- Issuance and Disposal of Documents
- Retrievability of Documents
- Presentation of Documents
- Review of Documents
 Good Documentation practice
GDP

"Right-first-time“ approach for the document is GDP

(to ensure identity, authenticity and accuracy of records.)

If your Document says “What actions took place in the development

or manufacturing of product so that anyone, including auditor or
inspector has documented evidence that you did exactly what you
said ” that is GDP.
 Regulatory Requirements

 FDA Q7A Good Manufacturing Practice Guidance for Active

Pharmaceutical Ingredients, Section VI. Documentation and Records

 ICH Good Manufacturing Practice Guide for API Q7, Section 6

Documentation and Records

 21CFR58 : Good laboratory practice, Subpart J.

 ISO 9001- 2008, Clause 4.2 : Documentation requirements

 Guide to GMP for Medicinal Products Part 1, Chapter 4 Documentation:

PIC/S PE 009-8 (Part I)
 The purpose of documentation

 Proof of fact
 Record
 Regulatory requirement
 Quality maintenance and improvement (Better risk management
and robust quality systems)
 Control the processes (Resource optimization )
 “Your documentation is an advertisement for your work”
 End User requirements
 To improve performance
 Enables important messages to be communicated clearly and
accurately.
 Why Documentation ?

Cost for Good

Documentation

Cost for Poor/No

Documentation
 Documentation life cycle
 Document creation & Approval: -
The process owner or the authorized person should write as per the
specific format and template and circulate the document after getting
approval of QA.

 Document use & Data collection: -

Responsibility of all technicians, engineers, scientists, operating persons
who are trained and authorized to collect and record data.

 Data Verification: -
Responsibility of supervisors, managers and all individuals trained &
authorized to review data.

 Record Review & Product disposition / Approval: -

Responsibility of QA or those trained & authorized to review records
 Cont….

 Record Archiving:-
Records are Accessible, Retrievable, Secure is the responsibility of QA &
relevant departments

 Record Destruction: -
As per SOPs that directs the destruction of documents
Who Participates in Creating the Documents?

Everyone involved in the process or procedure

 Managers
 Team Leads
 Staff doing the work or impacted by the work
 Include ALL departments and divisions impacted
 Consultants may assist
 WHEN ?

 During implementation, all

 New Process or documentation is created and
Procedure tested by all impacted
departments
 During implementation, all
 Change to an existing documentation is reviewed,
Process or Procedure updated, and tested by all
impacted departments
 Annually, review all documentation
to ensure it is accurate. Use as
 Periodic Review part of continuous process
improvement cycle to evaluate need
for change
 Where documentation ?

 Documentation during Project Design,

 Documentation during Construction Phase,

 Documentation during Commissioning and start-up,

 Documentation during Qualification and Validations

 Documentation during Commercial Production,

 Documentation during Testing and Release,

 Documentation for Regulatory submissions.

 Documentation beyond…………
 GDP standards

Document creation
 Contemporaneous with the event they describe
 When electronically produced, the documentation must be
checked for accuracy
 Free from errors
 For some types of data, the documentation must be in a format
that permits trend evaluation

Document approval
 Approved, signed, and dated by appropriate authorized
personnel.
 Document Signatures
 All documentation used to provide evidence that standards are
being followed must be signed and dated by authorized person as
it adds value to the document.
 Means of Signature
 For the approval
 Authorized person involved in it
 No signature pads, scanned signatures, or duplicated original
signatures shall be used to replace a handwritten signature by
the person signing.
 Documents shall be signed in permanent ink.
 Signatures shall be kept throughout the life of the document.
 The local date shall be used to date documents.
 Handwritten entries

 Adequate space is provided for expected handwritten entries

 Handwritten entries are in indelible ink
 Critical entries must be independently checked
(SPV, or second person verified)
 No spaces for handwritten entries are left blank - if unused, they
are crossed out or "N/A" (or similar text) entered
 Ditto marks or continuation lines are not acceptable
 A stamp in lieu of a handwritten signature is not acceptable
 Document maintenance

 Regularly reviewed and kept current

 Record for the creating, issuing and modification should be
there
 Retained and available for appropriate duration & in appropriate
condition
 Electronic document management systems are validated
 Electronic records are backed up
 Document modification

 Handwritten modifications are signed and dated

 Where appropriate, the reason for alteration must be noted
("E.E." is a common abbreviated reason, indicating "Entry Error")
 Controls exist to prevent the inadvertent use of superseded
documents
 Electronic versions can only be modified by authorized personnel
and controlled by password or other means
 A history must be maintained of changes and deletions to
electronic versions as well as paper documents.
 Uncontrolled changes can have a substantial impact on a
company‟s ability to demonstrate compliance to their specific
standards.

Reference : Document Creation and Change Request form. HQR - 423 -01.
 Corrections/Additions
1. In Record
 Single line through the information that needs to be corrected.

 All corrections or additions shall be signed and dated.

 Should not to scribble out the original data, use white out or
write over data .
2. In Document
 Only personnel who have already been approved to write or make
changes to document can correct or add to documents.

 Non-typographical error corrections or additions indicating a

change in data or acceptance status require a comment. And
routed through full document Change control.
 Typographical error change or additions do not require approval.

Reference : Document Creation and Change Request form. HQR - 423 -01.
 Document review
 Responsibility of supervisors, managers and all individuals trained
& authorized to review documents and data at specific time
interval.
 An approved list of designees, originators, and reviewers shall be
maintained.

Designees
 If a designee is to be used, then that person signs his/her name,
adds the words “signing for,” and adds the original printed name
of the approver.
 Designees must have the knowledge, skills, and abilities to
perform the assigned authorship, verification, or approval
activity.
Document retention time and responsible person
Review of the quality related documents
 Types of the Documents

 Commitment Documents :
Relationship between industry and the regulatory authorities
Exa : NDA, SMF

 Directive Documents :
Relationship between the Management and Employees
Exa : Specifications, STPs, SOPs, MFRs etc.

 Record Documents :
Relationship between the Employees and the Work they perform
Exa : Protocols, BMRs, Log Books, Calibration Records etc.
 Copy of the Documents
Clear, legible
Errors should not introduced during copying
No any copy is allowed unless if it is stamped particularly
 Master Copy
Original copy of the document
 Controlled Copy
The copy of the document from master copy and used in regulated
environment signed and stamped by qualified person.
 Uncontrolled copy
The copy of the document from master copy, made for information
purpose only.
 Superseded copy
Old version of the copy which is replaced by the latest version of the
document
 Obsolete copy
Copy of the document which is to be discontinued
 GMP DOCUMENTS
Specifications Standards
 Tests on identity, content, purity and quality
for starting and packaging materials Pharmacopoeias, reference standards, and
 Specifications for intermediate, finished, and other reference materials should be available
bulk products. in the quality control laboratory.
 Specifications for water, solvents and
reagents (e.g. acids and bases) used in
production.
Master formula Record Packaging instruction
BMR BPR
Records should be maintained of the A batch packaging record should be kept for
distribution of each batch of a product in each batch or part batch processed.
order to facilitate the recall of the batch if
necessary.
Line clearance Analytical Records
Before any processing begins, a check should be
Analysis records, the tests performed should
made and recorded. (That the equipment is
be recorded
clean and work station are clear of previous
products, documents, or materials not
required for the planned process)
Equipment Records
Records should be kept for major and critical
equipment of any
Validations and Calibrations
Maintenance and repair operations and cleaning
 Cont….
Standard operating procedures
 Equipment assembly and validation
 Analytical apparatus and calibration
 Maintenance, cleaning, and sanitization
 Personnel matters including qualification, training, and hygiene
 Environmental monitoring
 Pest control and assigning responsibility for cleaning and sanitation
 Complaints, Recalls, Returns and Sampling
 For testing materials and products at different stages of manufacture describing
the methods and equipment to be used.
 For the internal labelling, quarantine and storage of starting materials, packaging
materials and other materials
 For the receipt of each delivery of starting material and printed packaging
material.
 Typical elements of a documentation system

 Logo
 Title
 Doc. no
 Effective date
 Revision
 Page no
 Signature
 Format
 Stamp
 Document Numbering
 All document shall have a unique document number.
 This is typically issued by a document control department or
person (Quality Assurance).
 Date & Time

 A legal date is comprised of a month, day, and year, although not

necessarily in that order. Local conventions are assumed unless
otherwise specified in an SOP.
 It should be in uniform format. For example : DD/MM/YY or
DD/MM/YYYY
 Postdating (entering a date of the future) is not permitted
 Backdating (entering a date on a day after the entry was made or
the task was performed) is not permitted
 If times are required, procedures identifying approved guidelines
for documenting date and time (AM/PM or 24 hr) shall be
defined.
 Document Effective Date

 Date of the change or the date from which the document become
live.
 Effective date changes on every new change in the document.
And each change should be recorded at change history at the
front page of the document

Document Review Date

 Date given to the document after the respective departmental
head review the document in consultation with actual user.
 And after approval all the master and controlled copies are
stamped as “REVIEWED” on the document with review and next
review date.
 Document Review
 Document review will focus on the document‟s content, context,
format and grammar.
 The document quality attributes of concern document review are
correctness, usability, appropriateness and maintainability.
 Review factors and criteria are :
 Adherence to standards
 Consistency and traceability
 Readability, comprehensibility, and general understandability
 Technical adequacy and feasibility of approach
 Degree of completeness
 Testability of requirements
 Use of appropriate requirement, design, or coding techniques
 Appropriate level of details

Reference : http://www.wildfire.gov/pmu/pmo-rchive/products/documents/Review_Guidelines.pdf
 Document Revision
 All documents shall have a revision level & latest document should live.
 Two type of the revision
1. Routine revision :
- No technical or editorial modification but at the end of the two
years of the effective date.
- HOD will review and if there is no any change then HOD shall send
internal communication that this document doesn‟t need revision.
- If yes then Review the document and stamped as “REVIEWED”
- Valid only twice then document is revised as per DCC procedure.
2.Technical or editorial revision :
This type of the revision shall be carried out by Document change
control procedure and recorded.

 Every piece of a document shall be marked with the page number as

well as the total number of pages in the documents. X of Y.
 Signature & Date

 Document which doesn‟t has sign and date of the approval

consider as the incomplete document.
 All documents shall be signed by the originator.
 No signature pads, scanned signatures, or duplicated original
signatures shall be used to replace a handwritten signature by
the person signing.
 Documents shall be signed in permanent ink.
 Signatures shall be kept throughout the life of the document.
 The local date shall be used to date documents.
 Common Documentation Error

 Missing signature and dates at the time the activity is

performed.
 The “write over” and the “scribbler”.
 Non uniform date and signature entry.
 Data entries that do not correspond to the batch record
instructions.
 Writing a note that activity was performed on one day and
signed for on other day.
 Blanks on batch production records.
 Pre-recording of data.
 Incomplete references.
 Review not signed.
 Illegible writing.
 Too many corrections.
Common Documentation error
 How to acquire GD practice ?

 FDA statement should drilled into you from day one

„'If you didn't document it, then it didn't happen„‟.
 On one hand do the work, On other make the document
 Use indelible (water-resistant) blue or black ink
 Never use White ink to remove error
 Do not use pencil or felt-tipped marker
 Never overwrite or Scribbled the entry. Just single cut the error
with sign and date.
 Never leave space or blank in the document and Draw a diagonal
line through any blank fields or empty spaces at the bottom of a
page and include 'N/A' along with your initials and date.
 Cont….

 NEVER back date, NEVER post date and date in uniform format
 Each page in a controlled notebook chronologically.
 When entering repetitive data, do not use ditto marks.
 For instrument printouts, adhere with clear adhesive tape and
include your signature and date where the printout is attached.
 Signature logs must be maintained, indicating each employees
printed name, signature and date.
 We should forget the syndrome “We can fix the documentation
later .......”.

Reference : HQR - 423 - 02 Employee Signature Form

 Benefits of good documentation

 Unlock the potential of individual using the document

 Amplify the value of your product
 Build confidence in your quality
 Good Documentation helps to save the papers
 Reduce the efforts to compliance with regulatory bodies
 Good documentation enables to achieve the results that you are
seeking for.