Preparing For OCP NAPRA Standards - Liu PDF
Preparing For OCP NAPRA Standards - Liu PDF
Canada’s
Proposed
Implementatio
n Plan
Phase 1: January 1, 2020 – Assessing Risks and
Gaps
Ontario Evaluate current practices and determine what
College of areas require work in order to be compliant with
standards
Pharmacists
Phase 2: July 1, 2020 – Personnel Training and
Quality Assurance
Highest workload
Phase 3: January 1, 2021 – Facilities and
Equipment
Planning
Where do I
begin?
Phase 1:
• Gap Analysis
How do I • Risk Assessment
Prepare for Phase 2:
Implementation • Policies & Personnel
• Training
of the • Master Formulations
Upcoming • Beyond Use Dates
Standards? • Label and Packaging
• Storage
• Unpacking/storage
• Cleaning
• Quality Assurance
Phase 3: Facilities
Phase 1
Assessing Risks and Gaps
Self-Assessment Criteria for Non-Sterile
Compounding Standards can be found on OCP
website
Gap Analysis
Regulatory Framework
Risk Assessment for Compounding
Requirements for All Compounding Activities
non-sterile compounding supervisor
establish policies and procedures
training
Gap Analysis: facilities and equipment
Current State Product and Preparation Requirements
BUD
Master formulation/compounding records
Verification
Labelling and packaging
Recall
Quality Assurance
Requirements for hazardous preparations
Gap Analysis
Name,
Concentration, References
Form, Route
Refer to Guidance
Document for required
components of Master
Formulation
• official or assigned name, strength and dosage form of the
preparation
• expected yield
• calculations
• description and quantity of all ingredients
Master • compatibility and stability data, including references when
Formulation available
• references used to develop the formula and the consultation
Records date, as appropriate
• equipment needed to compound the preparation (and any
special cleaning instructions)
• personal protective equipment (PPE)
• source or origin of the formula
• mixing instructions, which may include:
• order of mixing
• mixing temperatures or other environmental
controls
• duration of mixing
• other factors pertinent to replication of the
preparation as compounded
Master • sample labelling information, which should
contain, in addition to legally required information:
Formulation • generic name and quantity or concentration of
each active ingredient
Records • assigned BUD
• storage conditions
• prescription or control number, whichever is
applicable
• type of container used in dispensing
• packaging and storage requirements
• description of final preparation
• quality control procedures and expected results
Type of Preparation NAPRA Beyond Use Date
Quality Training
Cleaning
Annually
Daily
Assurance Hazardous Wipe Every 6 months
Sampling
Policy review Every 3 years
Equipment As per manufacturer
Review Risk Yearly
Assessment for non-
sterile preparations
Phase 3 - Jan 2021
Personnel Training and Quality and Assurance
Level A
Separate space designated for compounding
Closed door cabinets for storage
Away from traffic
Establish Work surfaces – smooth, non-porous
Facility Stored off floor, well lit
Requirements Level B
well ventilated, closed off room (minimum 12
air exchanges per hour) & negative pressure OR
room with a ventilated containment device
Level C
Physically separate, externally vented room through
HEPA filtration
12 ACPH, negative pressure (-2.5 Pa)
CPEC – externally vented or have redundant HEPA
Establish filters in series (Class 1 BSC, Class 2 BSC or CACI)
Facility Can use sterile chemo cleanroom with C-PEC (Class 2
B2 BSC) if:
Requirements Ensure all sterile compounding completed for day
Does not occur when sterile compounding in
progress
Full decontamination and deactivation of hood
clean required following completion
Level C cont’d
Eyewash station
Appropriate area for unpacking products that appear
Establish damaged
Facility Smooth impermeable surfaces resistant to cleaning
Requirements products
Storage of hazardous products
Determine facility requirements
No minimum size requirement
Should be large enough for staff to work comfortably
and safely with room to store equipment and products
in orderly manner in clean and secure surroundings
Establish If multi-site organization, consider consolidation of
Facility sites
Create business plan for corporate review if facilities do
Requirements not meet standards
Early initiation
Ministry funding vs Capital funding
Fiscal year capital plan consideration
Plan ahead! Takes time to receive funding.
Example:
Non-sterile
non-hazardous
and hazardous
compounding
area
Keep on your radar….
What’s Next?
Sept 23, 2019: USP postponed official date to address appeals on publications for
795, 797.
USP (2018, April 20). Open Microphone Session on USP General Chapter <795> Pharmaceutical Compounding –
Nonsterile Preparations. Presentation. www.usp.org/compounding/general-chapter-795
Expected update following release of USP 795
USP 795 proposed revisions include:
Handling and storage Hazardous Drugs
PPE Procedures
USP Update Packaging and Drug Preparation Containers
Compounding Documentation
Cleaning frequency requirements – after spills, surface
contamination
Every 3 months – walls, ceilings, storage shelving
Daily – floors
USP (2018, April 20). Open Microphone Session on USP General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations.
Presentation. www.usp.org/compounding/general-chapter-795
Equipment – containment ventilated enclosure (CVE)
-measuring, weighting or manipulating powders or airborne
contamination from drug particles
Quality Control
USP Update BUD revision
Level Requirement Revisions
Adverse event reporting
USP (2018, April 20). Open Microphone Session on USP General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations.
Presentation. www.usp.org/compounding/general-chapter-795
Type of Preparation NAPRA Beyond Use Date
Beyond Use
Non-aqueous formulation 6 months
Date: 90 days RT
New proposed
Preserved water-containing 30 days RT
upcoming USP 795
changes…. formulation
Non-preserved water- 14 days F
containing formulations
Solid dosage forms 180 days RT
What not to do...
Health Canada, Health Products and Food Branch Inspectorate. Policy on manufacturing and
compounding drug products in Canada (POL-0051). Ottawa, ON: Health Canada; 2009. Available
from: http://www.hc-sc.gc.ca/dhp-mps/compliconform/gmp bpf/docs/pol_0051-eng.php
Kastango, E. Lessons Learned from Compounding Tragedy. CJHP 2013. 66(3):152-153
USP (2018, April 20). Open Microphone Session on USP General Chapter <795> Pharmaceutical
Compounding – Nonsterile Preparations. Presentation. www.usp.org/compounding/general-
chapter-795
National Association of Pharmacy Regulatory Authorities (NAPRA). Model standards for pharmacy
compounding of non- sterile preparations. Ottawa, ON: NAPRA; 2018.Available from:
References https://napra.ca/sites/default/files/documents/Mdl_Stnds_Pharmacy_Compounding_Nonsterile_
Preparations_March2018_FINAL.pdf
National Association of Pharmacy Regulatory Authorities (NAPRA). Guidance document for
pharmacy compounding of non- sterile preparations. Ottawa, ON: NAPRA; 2018.Available from:
https://napra.ca/sites/default/files/documents/Mdl_Stnds_Pharmacy_Compounding_Nonsterile_
Preparations_Guidance_June2018_FINAL.pdf
United States Pharmacopeial Convention (USP). In: USP compounding compendium. Rockville,
MD: USP; 2016.Available from: https://www.usp.org/compounding [Contains all USP chapters
useful to pharmacists, including General chapter <795>: pharmaceutical compounding — nonsterile
preparations]
Questions?
Contact: [email protected]