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PR3145 > L1 - Role of Pharmaceutical Inspector > Flashcards

L1 - Role of Pharmaceutical Inspector Flashcards

1
Q

What can be falsified in falsified medicines?

A
  • name of manufacturer
  • name of market authorisation holder
  • batch no.
  • packaging/labelling
  • identity/composition
  • manufacturing records/ certificates of analysis
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2
Q

Role of Pharmaceutical Inspector in regulating medicinal products

A

To inspect manufacturer’s compliance to PICS GMP Standard:

  • Manufacturer’s license to manufacture therapeutic product
  • Compliance with PIC/S GMP standard a pre-requisite for issuance & retention of license
  • Periodic audits (18-36mths) by Inspectors from HSA
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3
Q

Expectations of Regulators (inspectors, reviewers, analysts)

A
  • To weed out adulterated, counterfeit & falsified products
  • To ensure safe, efficacious & quality products
  • To oversee drug/API manufacturing & supply chain
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4
Q

How many PIC/S members (as of 1 Jan 2020)

A

53

- SG joined as 1st Asian member on 1 Jan 2000

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5
Q

What is the goal of PIC/S?

A

To LEAD international development, implementation & maintenance of harmonised GMP standard (for manufacturers) & Quality system (for Inspectorates) in the field of medicinal products

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6
Q

What is GMP?

A

GMP = Good Manufacturing Practice: Quality System Standard implemented by pharma manufacturers to ensure:

  • Medicinal pdct is consistently manufactured & controlled
  • to the quality appropriate for its intended use
  • as required by its market authorisation
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7
Q

9 Chapters of PIC/S GMP Standard

A

1) Pharmaceutical quality system
2) Personnel
3) Premises & equipment
4) Documentation
5) Production (incl packaging)
6) Quality control
7) Outsourced activities (contract manufacture & analysis)
8) Complaints & product recall
9) Self inspection (IQA)

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8
Q

Objectives of warehouse inspection

A

Assess that:

  • All starting materials have approved specifications
  • Materials from approved suppliers
  • Procedures (SOP) in place (eg handling receipt, quarantine, sampling, release of materials, handling of rejected materials & products)
  • Environment of warehouse (temp, RH monitoring, pest control)

-> Chapter 3 (premises: storage area) & 5 (production: starting materials)

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9
Q

Objectives of weighing room inspection

A

Assess that:

  • Calibrated, accurate & reliable balances used
  • Weighted materials are of correct identity, quality & qty
  • Appropriate PPE & envt controlled to prevent cross-contamination

Items covered during audit:

  • Calibration of weighing balances
  • Labelling of starting materials
  • Personnel wearing appropriate PPE
  • SOP for weighing method
  • Dust extracting system & housekeeping of weighing room

-> Chapter 5 (production: dispensing)

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10
Q

Objectives of inspecting production department

A

Assess that:

  • Premises designed to prevent cross-contamination
  • equipment effectively clean & regularly maintained
  • restricted access only to authorised personnel (in appropriate PPE)
  • materials of correct identity, qlty & qty
  • critical processes validated/re-validated
  • in-process quality controls
  • comprehensive batch processing records

-> Chapter 5 (production: 5.1-5.71)

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11
Q

Areas covered during inspection of Production Department

A

4M1P

  • Premises
  • Machine
  • Method
  • (Starting) Materials
  • Manpower
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12
Q

Areas covered during inspection of Packaging Room

A
  • Premises (Packaging room)
  • Machine (Packaging equipment)
  • Method (Packaging process)
  • Packaging Materials
  • Manpower (Personnel)
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13
Q

Objectives of inspecting QC department

A

Assess that:

  • Properly trained analyst & there is independent authority for head of QC
  • QC methods approved by HSA, accurate & reliable as evident from records of analytical method validation & routine QC test results
  • Procedures put into place for maintenance, calibration, status labelling & assuring integrity
  • Procedures in place for receipt, storage, security, record-keeping of test samples, reagents & reference standards

-> Chapter 6 (QC: 6.1-6.41)

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14
Q

Other premises that are being inspected

A

Ancillary Premises
- engineering workshop, rest room, corridors

External Premises/Outsourced Activities

  • contract testing lab
  • -> NOTE: If certified by ISO 17025, need not additional checks by HSA
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15
Q

Objectives of Documentation Audit

A

Assess that:

  • legal requirements complied by manufacturer
  • regulatory commitments to HSA complied
  • manufacturing SOPs (eg. product quality reviews, handling of complaints, self-inspection) are followed
  • manufacturing records authentic
  • manufacturer conforms to legal & regulatory requirements & PIC/S GMP Standard
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16
Q

Complaints & product recalls

A
  • Designated person should be responsible for handling complaints & deciding on actions to be taken
  • Written SOP
  • All complaints should be recorded, investigated & closed out
  • Reviewed regularly
  • -> Competent Authority (Regulatory Authority) should be notified if manufacturer is considering product recall
  • -> Product should be stored securely while awaiting decision
  • -> Progress should be reported & final report issued
  • -> Effectiveness of recall procedure should be evaluated regularly
17
Q

Self-Inspection

A
  • Carried out at periodic intervals in accordance with pre-arranged program
  • Areas covered should include all 9 chapters & relevant annexes of PICS GMP standard
  • Conducted in independent & detailed way by designated competent persons
  • Independent audits by external experts also useful
  • Recorded
  • Statement of eventual actions taken recorded
18
Q

20 annexes of PIC/S GMP Standard

A 
1 - Sterile products
2 - Biological products
3 - Radiopharmaceuticals
4 & 5 - Veterinary products (not applicable)
6 - Medicinal gases
7 - Herbal medicinal products
8 - Sampling of starting & packaging materials
9 - Manufacture of liquids, creams & ointments
10 - Inhalations
11 - Computerised systems
12 - ionising radiation
13 - investigational medicinal products
14 - Blood products
15 - Qualification & process validation
16 - Qualified persons (EU only)
17 - Parametric release
18 - Empty
19 - Retention samples
20 - Quality risk management (voluntary)

PR3145 (10 decks)

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