1
Q
ICHQ 10 definition of PQS
A
PQS is a management system to direct and control a pharmaceutical company with regard to quality
2
Q
Describe product lifecycle
A
- market research
- research drug
- develop drug
- clinical trials
- manufacture
- market, sell & distribute
- discontinue
3
Q
GxP interactions
A
- GLP - GCP
- to ensure GLP studies are complete
- formal system to start trials - GCP - GMP
- arrangements for unblinding
- audited
- storage - GMP - GDP
- transport conditions
- security of routes
- RP/QP interface
4
Q
Define the role of senior management
A
- an effective PQS is in place
- responsibilities are defined
- they ensure the support & commitment of staff at all levels
- ensure stability of QMS & GMP compliance
Eudralex vol 4 C1 & ICH Q10
5
Q
People & PQS
an effective PQS should have:
A
- an org chart
- job descriptions
- appropriate recruitment selection criteria
- training records
- performance appraisal
6
Q
Legal basis for personnel requirements
A
- EU GMP D 2017/1572 article 7
- eudralex vol 4 C2
- ## ICHQ10
7
Q
Purpose of a PQS
A
- ensures product quality, safety & efficacy
- protects patient
- consistent process
- reduces error
8
Q
Storage requirements
A
- adequate segregation
- racking (no product on floor)
- HVAC
- secure locations
- rejected/ quarantined product segregated
- cleaning documented
- pest control
9
Q
Role of RP
A
- WDA must name RP
- responsible for management of PQS at wholesalers
- safeguard supply of medicines
- coordinate recalls
- SI
ensures compliance of the wholesaler with GDP
10
Q
What are the 2 primary types of documents
A
- Instructions
- tech agreements
- specifications
- SOPs - Records
- reports
- CofA
- records
11
Q
Hierarchy of documents
A
- Quality manual
- Policies
- SOPs
- Records
12
Q
Documentation lifecycle
A
- Create
- Review
- Approve
- Train
- Use
- Withdraw
- Archive
- Destroy
13
Q
Review responsibilities:
1. user
2. SME
3. QA
A
- Document accuracy
- consistent with other documents
- accuracy - technical & scientific
- assessment of wider impact
- GMP compliant
- compliant with licence & policy
14
Q
What is the Quality Policy
A
- overall intentions & direction of an organisation related to quality
- describes philosophical approach to quality
- often signed by CEO
15
Q
What is the quality manual?
A
- document specifying the PQS of an organisation
- should include description of all elements of the PQS as well as ownership
16
Q
Purpose of Change Control
A
- systematic approach to managing change
- risk assess
- document proposal & decisions
17
Q
Key features of CC system
A
- defines when CC is required
- ensures assessment of all impacted areas
- impact assessment
- simple & easy to use
- auditable & fully traceable
18
Q
Key steps of a CC
A
- Propose change
- Impact assessment
- Risk assessment
- Change approval/ rejection
- Change plan (pre/post imp, define acceptance criteria)
- Implementation
- Review
- Post imp actions
- Effectiveness check
- Closure
19
Q
Material management
A
must minimise:
- mix up
- material spoilage
- lost of traceability
- unapproved use
- damage
Defined in eudralex vol 4 C 3 & 5
20
Q
EudraLex Vol 4
Chapters
A
- PQS
- Personnel
- Premises & Equipment
- Documentation
- Production
- QC
- Outsourced activities
- Complaints & recalls
- Self inspection
21
Q
EudraLex vol 4
Parts
A
- Basic requirements for medicinal products (contains the chapters)
- Basic requirements of actives & starting materials
- GMP related documents
22
Q
EudraLex vol 4
Annexes
A
- Manufacture of sterile products
- Manufacture of biological active substances
- Manufacture of radio pharmaceuticals
- Manufacture of veterinary
- Manufacture of immunological vet
- Manufacture of medical gases
- Manufacture of herbal medicines
- Sampling of starting & packing materials
- Manufacture of liquids, creams & ointments
- Manufacture of pressurised meter dose inhalers
- Computerised systems
- Use of ionising radiation
- Manufacture of IMPs
- Manufacture of product derived from human blood
- Qualification & validation
- Certification by QP & batch release
- Parametric release
- X
- Reference & retention samples
- X
- Importation of medicinal products
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Importation
23
Q
Engineering standards
A
- ISPE baseline & guides
- ISO
- BS & DIN/EN standards
- ASTM international standards
24
Q
Audit
A
An official inspection of an organisation, typically by an independent body
Systematic review of PQS
25
Hierarchy of audits
1. Regulatory
2. Corporate
3. Site
4. Vendor/ supplier
5. Departmental
6. Self inspection
26
Product realisation
Achievement of a product with the quality attributes appropriate to meet the needs of:
- patient
- HCP
- regulatory authorities
27
What is technology transfer?
- transfer of product & process knowledge from development to manufacturing
- scale up to commercial scale
-
28
What is validation
Providing documented evidence that a process, method or equipment will consistently achieve the desired results
29
What should be validated
- new processes
- manufacturing processes
- facilities & equipment
- automated systems
- analytical
- cleaning
30
Define DMAIC
Define
Measure
Analyse
Improve
Control
31
Corrective action
Action to prevent reoccurrence
Eg. Sensor fails, incorrect instructions in PM - CA improves instruction
32
Preventative action
Action to prevent occurrence
Review other PMs of similar equipment
33
Regs expectations complaints & recalls
Eudralex vol 4 ch 8
Designated & defined responsibilities
Notification to management
Written procedures
Effectiveness of recall (mock)
34
Complaint types
1. Quality defect - faulty manufacture, deterioration, falsification
2. Adverse Event - any untoward medical occurrence
3 . Adverse reaction - a noxious unintended response to a medical product
35
Recall - inform competent authority, legal basis
Article 13 2017/572
36
Typical recall procedure
Quarantine product (in stock/ transit)
Involve QP
Contact DMRC
Retrieve distribution records
Customers contacted
Return procedure implemented
Goods isolated & reconciled
Write report
37
Classification of recall
Class 1: - defects potentially life threatening. Immediate action required
Class 2: - could cause illness
Action within 48hrs
Class 3: - may not pose a significant hazard to health
Action within 5 days
Class 4: - caution in use (UK only)
38
Level of recall
Level 0 - recall from company’s own stock
Level 1 - recall from wholesalers
Level 2 - recall from retailers, pharmacies & hospitals
Level 3 - recall from individual patients
39
Management review
E vol 4 ch 1
There should be a periodic management review with the involvement of SM to identify opportunities of improvement, product & PQS
40
Purpose of management review
- A structured approach to review & evaluate effectiveness of PQS
- ensure quality risks are managed
- drives development
41
Role of SM in PQS
- hold ultimate responsibility
- establish a quality policy
- ensure commitment from all staff
- procedures established for management review
42
PQR
E vol 4 ch 1
Regular periodic quality reviews should be conducted to verify the consistency of process and the appropriateness of current specs
43
Eudralex requirements for PQR
Review:
Starting materials
Critical IPCs
Failed batches
Deviations
Changes
MA variations
Stability data
Complaints & recalls
Previous CAPAs
Qualification
QP Study
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