PQS Flashcards
What details should you collect in the event of a product complaint?
Chapter 8- product complaints and recall
Date/time of complaint + defect found
Name/address of complainant
Product information
-Batch number EXP
-Serialisation details
- Strength, dosage form
- Storage conditions kept
Nature of complaint
Address of pharmacy/wholesaler
Date purchased
What would you expect to be in a typical complaint investigation?
Initial date collection on batch/ complainant.
Assessment of patient/ user risk
Consideration for PV reporting for ADRs
Initial maufacturing/QC/Storage review
Assessment of returned/ in house samples
QC analysis of samples/raw materials
Review of other batches
Investigation considering counterfeit
Conclusion- RCA and CAPAs
Report (PV in mind)
Response to complainant
Track and trend of complaints
Describe the steps outlined in ICHQ9
What are the two ‘principles’ of QRM?
Initiate process
Hazard identification
Risk analysis
Risk evaluation
Risk reduction
Risk acceptance
Review events
- Use of scientific and product knowledge linked to patient safety
- Level of effort, formality and documentation should be commensurate with the risk
How would you define a PQS? Where would you find guidance?
Management system to direct and control a pharmaceutical company WRT quality and achieve MA compliance
Ensure consistent patient safety, quality and efficacy of products
ICHQ10/ Eudralex vol 4 part 1 chapter 1.
What is in a PQR? Where do you find guidance?
Guidance found in chapter 1 Eudralex part 1
Review of sourcing and starting materials
Supply chain traceability for APIs
Finished product QC results
Review of batches failing to meet specification
Significant deviations
Change controls
MA Variations
Stability results
Returns/complaints/recalls
Post marketing commitments
Qualification status of critical equipment
Review of annual contracts vs chapter 7 requirements
What are the responsibilities of the head of production?
Ensure products manufactured and stored to quality standards
Approve instructions
Approve records
Qualification/maintenance and validation of equipment
Training provided appropriate to need of department
What are the responsibilities of the head of QC?
Approve or reject material
Ensure necessary testing performed
Approve specifications/ procedures
What are the required documents on site?
Site master file
Instructions (Specifications, Manufacturing formula, Packaging instruction, SOPs, tech agreements)
Reports/Records (Records, reports, CofAs)
What is the retention period for documentation (records/reports)
1 year post expiry of product
or
5 years post certification, whichever is longer.
IMPs- 5 years post trial completion.
What is contained in a site master file?
General site information
QMS
Personnel
Premises and equipment
Documentation mgt
Production
QC activities
Recall process
Complaints process
Annexes;
Org charts
MIA
GMP certificate
List of key equipment
Water system diagrams
Contract manufacturers
What guidance is there for the prevention of cross contamination?
Chapter 5- production
Organisational (campaigns, clothing, waste handling) and technical steps (Dedicated plant/equipment, design, closed systems, barriers) to minimise cross contamination
EMA guidance on setting HBELs
What guidance is there for distribution of commercial products, API, IMP and excipients?
Commercial- 2013/c343/01 + Green guide
API- 2015/c95/01
IMP- None!
Excipients- None!
What controls are there for distributors of product?
Registration of brokers and wholesalers
MHRA database of WDA holders/ brokers
EU internet logo
What is the role of the RP?
What is role of RPi?
Named on WDA
Quality management at wholesaler
Implement PQS
Manage activities and records
Training and recall co-ordination
RPi - RP for importation
Named on WDA
Post brexit requirement
Verification of the EU QP certification
What are key guidance sources for premises/ Equipment maintenance?
ISPE
Chapter 3
ISO standards (9000 Quality, 1400 Environmental)
EN standards- 285, 1822
Describe a production tech transfer process
Describe an analytical tech transfer process
Guidance available in WHO Annex 7, Analytical in chapter 6
Need for robust documentation at transferring site - confirm all processes meet registration requirements
Technical transfer agreement between sites
Knowledge share- Development, CPPs, CQAs, IPCs, CPV data, equipment etc.
Gap analysis at receiving site
Transfer strategy defines how gaps will be filled
Equivalence strategy- dissolution, stability, Stats.
Analytical- ICHQ2, chapter 6, Annex 7 WHO
Detail important- all analytical knowledge.
Confirm what needs validation vs verification
Reference sample comparison- TOST, F2 dissolution.
What guidance is available for computerised systems?
What are the different categories?
What are GMPs of computerised systems?
Annex 11
ISPE guidance- GAMP categories
1- Infrastructure
3-Non configured
4- Configured
5-Bespoke
Supplier has a PQS
Error scripting
Data transfer validation
Data integrity- Audit trails and password protection.
What guidance is available for validation?
What would a site validation master plan contain?
What is contained in the validation lifecycle?
Annex 15
VMP;
1. Q/V Policy
2. Org structure- responsibilities
3. Summary of facility/utility and status
4. Change control/deviation summary
5. Acceptance criteria guidance
6. Requalification plan
URS>FS>DS>IQ>OQ>PQ> validation
What is contained within a QTA?
Name and address of both parties
Scope of agreement
Key responsibilities assigned to each party
- Manufacture
- release
- Stability
- Distribution
- Complaints
- analytical QC testing
- PQR
- Sampling
List of products
Key contact details
Change history and signatures
What are the technical controls to prevent cross contamination?
Found in chapter 5
Dedicated facilities
Segregated production areas
Equipment dedication
Pressure cascades
Recirculation control
Equipment cleaning
Process design
Single use systems
What are the organisational controls for cross contamination?
Campaign manufacture planning
Clothing control
Cleaning design
Waste/spill control procedures
Supervision
What are the objectives of ICHQ10?
Achieve product realisation
Establish and maintain a state of control
Facilitate continuous improvement
Eudralex annexes list
1- Sterile Manufacture
2- biological api
3- radiopharma
4- vet products
5- immune vet products
6- gasses
7-Herbal
8- sample of starting and pack
9- liquids
10- PMDIs
11- computerised systems
12- ionising radiation
13- IMP
14- blood plasma
15- qual and validation
16- QP certification and release
17- parametric release
19- ref/retain
21- eu importation
