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PQS Flashcards

1
Q

ICHQ 10 definition of PQS

A

PQS is a management system to direct and control a pharmaceutical company with regard to quality

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2
Q

Describe product lifecycle

A
  • market research
  • research drug
  • develop drug
  • clinical trials
  • manufacture
  • market, sell & distribute
  • discontinue
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3
Q

GxP interactions

A
  1. GLP - GCP
    - to ensure GLP studies are complete
    - formal system to start trials
  2. GCP - GMP
    - arrangements for unblinding
    - audited
    - storage
  3. GMP - GDP
    - transport conditions
    - security of routes
    - RP/QP interface
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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

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5
Q

People & PQS
an effective PQS should have:

A
  • an org chart
  • job descriptions
  • appropriate recruitment selection criteria
  • training records
  • performance appraisal
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6
Q

Legal basis for personnel requirements

A
  • EU GMP D 2017/1572 article 7
  • eudralex vol 4 C2
  • ## ICHQ10
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7
Q

Purpose of a PQS

A
  • ensures product quality, safety & efficacy
  • protects patient
  • consistent process
  • reduces error
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8
Q

Storage requirements

A
  • adequate segregation
  • racking (no product on floor)
  • HVAC
  • secure locations
  • rejected/ quarantined product segregated
  • cleaning documented
  • pest control
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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

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10
Q

What are the 2 primary types of documents

A
  1. Instructions
    - tech agreements
    - specifications
    - SOPs
  2. Records
    - reports
    - CofA
    - records
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11
Q

Hierarchy of documents

A
  1. Quality manual
  2. Policies
  3. SOPs
  4. Records
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12
Q

Documentation lifecycle

A
  1. Create
  2. Review
  3. Approve
  4. Train
  5. Use
  6. Withdraw
  7. Archive
  8. Destroy
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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
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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
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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
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16
Q

Purpose of Change Control

A
  • systematic approach to managing change
  • risk assess
  • document proposal & decisions
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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
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18
Q

Key steps of a CC

A
  1. Propose change
  2. Impact assessment
  3. Risk assessment
  4. Change approval/ rejection
  5. Change plan (pre/post imp, define acceptance criteria)
  6. Implementation
  7. Review
  8. Post imp actions
  9. Effectiveness check
  10. 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
  1. PQS
  2. Personnel
  3. Premises & Equipment
  4. Documentation
  5. Production
  6. QC
  7. Outsourced activities
  8. Complaints & recalls
  9. Self inspection
21
Q

EudraLex vol 4

Parts

A
  1. Basic requirements for medicinal products (contains the chapters)
  2. Basic requirements of actives & starting materials
  3. GMP related documents
22
Q

EudraLex vol 4

Annexes

A
  1. Manufacture of sterile products
  2. Manufacture of biological active substances
  3. Manufacture of radio pharmaceuticals
  4. Manufacture of veterinary
  5. Manufacture of immunological vet
  6. Manufacture of medical gases
  7. Manufacture of herbal medicines
  8. Sampling of starting & packing materials
  9. Manufacture of liquids, creams & ointments
  10. Manufacture of pressurised meter dose inhalers
  11. Computerised systems
  12. Use of ionising radiation
  13. Manufacture of IMPs
  14. Manufacture of product derived from human blood
  15. Qualification & validation
  16. Certification by QP & batch release
  17. Parametric release
  18. X
  19. Reference & retention samples
  20. X
  21. Importation of medicinal products

memory aide:
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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
Q

Hierarchy of audits

A
  1. Regulatory
  2. Corporate
  3. Site
  4. Vendor/ supplier
  5. Departmental
  6. Self inspection
26
Q

Product realisation

A

Achievement of a product with the quality attributes appropriate to meet the needs of:
- patient
- HCP
- regulatory authorities

27
Q

What is technology transfer?

A
  • transfer of product & process knowledge from development to manufacturing
  • ## scale up to commercial scale
28
Q

What is validation

A

Providing documented evidence that a process, method or equipment will consistently achieve the desired results

29
Q

What should be validated

A
  • new processes
  • manufacturing processes
  • facilities & equipment
  • automated systems
  • analytical
  • cleaning
30
Q

Define DMAIC

A

Define
Measure
Analyse
Improve
Control

31
Q

Corrective action

A

Action to prevent reoccurrence

Eg. Sensor fails, incorrect instructions in PM - CA improves instruction

32
Q

Preventative action

A

Action to prevent occurrence

Review other PMs of similar equipment

33
Q

Regs expectations complaints & recalls

A

Eudralex vol 4 ch 8

Designated & defined responsibilities
Notification to management
Written procedures
Effectiveness of recall (mock)

34
Q

Complaint types

A
  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
Q

Recall - inform competent authority, legal basis

A

Article 13 2017/572

36
Q

Typical recall procedure

A

Quarantine product (in stock/ transit)
Involve QP
Contact DMRC
Retrieve distribution records
Customers contacted
Return procedure implemented
Goods isolated & reconciled
Write report

37
Q

Classification of recall

A

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
Q

Level of recall

A

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
Q

Management review
E vol 4 ch 1

A

There should be a periodic management review with the involvement of SM to identify opportunities of improvement, product & PQS

40
Q

Purpose of management review

A
  • A structured approach to review & evaluate effectiveness of PQS
  • ensure quality risks are managed
  • drives development
41
Q

Role of SM in PQS

A
  • hold ultimate responsibility
  • establish a quality policy
  • ensure commitment from all staff
  • procedures established for management review
42
Q

PQR

E vol 4 ch 1

A

Regular periodic quality reviews should be conducted to verify the consistency of process and the appropriateness of current specs

43
Q

Eudralex requirements for PQR

A

Review:
Starting materials
Critical IPCs
Failed batches
Deviations
Changes
MA variations
Stability data
Complaints & recalls
Previous CAPAs
Qualification

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