PQS Flashcards
(16 cards)
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
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 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
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 are the objectives of ICHQ10?
Achieve product realisation
Establish and maintain a state of control
Facilitate continuous improvement
