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Pharma Compliance > Role of the Pharmaceutical Inspector in Regulating Medicinal Products > Flashcards

Role of the Pharmaceutical Inspector in Regulating Medicinal Products Flashcards

1
Q

Why is there a need to inspect pharmaceutical manufacturers?

A

To prevent adulterated, falsified and counterfeit medicinal products that pose serious quality, health risks and patent violation issues from making it to the market and becoming distributed to the consumers.

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2
Q

What are falsified medicines and their components?

A

Falsified medicines are medicinal products /APIs with false representation.

These may include falsified:

  • Name of Manufacturer
  • Name of Market Authorization Holder
  • Batch Number
  • Packaging/Labelling
  • Identity/Composition
  • Manufacturing Records/Certificate of Analysis
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3
Q

What is the role of a pharmaceutical manufacturer?

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

Introduction to Pharmaceutical Inspection Cooperation Scheme (PIC/S)

A
  • Under Singapore Medicines Act/Health Products Act, a Manufacturer’s License is required for the manufacture of medicinal products.
  • Compliance with PIC/S GMP standard is pre-requisite for the issuance and retention of the Manufacturer’s license.
  • GMP Compliance assessed through periodic audits by Inspectors from HSA.
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5
Q

What are the 9 chapters for the PIC/S GMP Standard?

A
  1. Pharmaceutical Quality System
  2. Personnel
  3. Premises and Equipment
  4. Documentation
  5. Production (including Packaging)
  6. Quality Control
  7. Outsourced Activities (Contract Manufacture and Analysis)
  8. Complaints and Product Recall
  9. Self-inspection (IQA)
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6
Q

What are the areas covered during a GMP inspection?

A

Input –> starting materials (warehouse)
Production & packaging –> processes (weighing room, production areas, packaging room)
QC Testing –> finished dosage forms (QC laboratories, document audit)
Output

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7
Q

What are the objectives of warehouse inspection?

A

Assess that:

  • All starting materials (APIs, packaging materials and finished products) have approved specifications, and materials are purchased from approved suppliers.
  • Procedures (SOP) are in place
  • Environment of warehouse (e.g. temperature & RH monitoring and pest control programs) preserves quality of materials and products stored.
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8
Q

What are the objectives of weighing room inspection?

A

Assess that:

  • Calibrated, accurate and reliable weighing balances are used.
  • Weighed materials are of correct identity, quantity and quality.
  • Authorised personnel wear appropriate PPE and environment of weighing room controlled to prevent cross-contamination.
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9
Q

What are the items covered during audit of weighing room?

A
  • Calibration of Weighing Balances
  • Labelling of Starting Materials
  • Personnel wear Proper Gowns and PPE
  • SOP for Weighing Method (& Records of Weighing)
  • Housekeeping of Weighing Room
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10
Q

What are the objectives of inspecting production department?

A

Assess that:
- Premises are designed to prevent cross-contamination

  • Equipment are effectively cleaned and regularly maintained.
  • Personnel Control Programs are in place:
    » Restricted Access only to authorised personnel
    » Authorised personnel wear appropriate gowns and PPE
  • Material of Correct Identity, Quantity and Quality are used for production
  • Process controls are in place:
    » Critical processes are validated / re-validated
    » In-process quality controls are in place
    » Comprehensive Batch Processing Records are kept
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11
Q

Items/Areas covered during inspection of Production Department?

A
  • Production Rooms (Premises)
  • Production Equipment (Machine)
  • Packaging Process (Method)
  • Personnel (Manpower)
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12
Q

Items/Areas covered during Inspection of Packaging Room?

A
  • Packaging Rooms (Premises)
  • Packaging Equipment (Machine)
  • Packing Process (Method)
  • Personnel (Manpower
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13
Q

Objectives of inspecting QC Department?

A

Assess that:

  • Properly Trained Analysts are available and there is Independent Authority for Head of QC.
  • QC Test Methods are HSA-approved, include records of Analytical Method Validation and Routine QC Test Results
  • Procedures are in Place for Maintenance, Calibration, Status Labeling and Assuring Integrity of QC Test Equipment.
  • Procedures are in place for Receipt, Storage, Security, Record-keeping of Test Samples, Reagents and Reference Standards.
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14
Q

Items/Areas covered under Inspection of QC Laboratories?

A
  • Chemistry Testing Laboratory
  • Other areas/activities inspected:
    » External Premises/Outsourced Activities:
    Contract Testing Laboratories
    » Ancillary Premises: Engineering workshop, Rest Room & Wash Room and Corridors
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15
Q

Objectives of documentation audit?

A

Assess that:

  • Legal requirements under Medicines and Health Products Acts are complied by Manufacturer.
  • Regulatory Commitments to HSA are complied by Manufacturer
  • Manufacturing SOPs (Product Quality Reviews, Handling of Complaints and Recalls and Self-Inspection) are followed.
  • Manufacturing Records are authentic.

i.e. Manufacturer Conforms to Legal & Regulatory Requirements and PIC/S GMP Standard

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16
Q

Areas/Items Covered under Documentation Audit

A
  • SOP & Records on Product Quality Review
  • SOP & Records of Product Complaints and Recalls
  • SOP & Records of Self-Inspection (IQA) Program
17
Q

Product Quality Review (PQR)

A

PQR should be conducted annually on all authorised products:

  1. Quality of starting materials
  2. Quality of finished products
  3. Failed batches of products
  4. Manufacturing Process/ QC deviations
  5. Changes to manufacturing processes and analysis methods
  6. Changes to market authorisations (product licenses)
  7. Stability testing program
  8. Components and product recalls - investigations and closed out
  9. Adequacy of previous CAPAs carried out
  10. Qualification status of key equipment and utilities
18
Q

Complaints process

A
  • a designated person should be responsible for handling complaints and deciding on actions to be taken.
  • a written procedure (SOP) on briefing complaints should be in place.
  • all complaints shall be recorded, investigated and closed out with decisions taken documented.
  • all complaint records should be reviewed regularly for any recurring trend.
19
Q

Recalls process

A
  • The Competent Authority (Regulatory Authority) should be notified if manufacturer is considering a product recall following serious quality defects, faulty manufacturers of counterfeit products.
  • A designated person, independent of Sales and Marketing, should be responsible for coordinating and executing recalls.
  • A written procedure (SOP) should be in place for product recall.
  • Distribution records should be readily available.
  • Recalled product should be stored securely while awaiting decision on its fate.
  • Progress of recall process should be recorded and final report issued.
  • Effectiveness of recall procedure should be evaluated regularly.
20
Q

Self-inspection process

A
  • Self inspection should be carried out at periodic intervals in accordance with pre-arranged program.
  • The areas covered during self-inspection should include all 9 chapters and relevant annexes of PICS GMP standard.
  • Self-inspection should be conducted in an independent and detailed way by designated competent persons from company.
  • Independent audits by external experts are also useful.
  • All self-inspections should be recorded.
  • Statements of eventual actions taken should also be recorded.
21
Q

What are the 20 annexes under the PIC/S GMP standard?

A

Annex 1 – Manufacture of Sterile Products
Annex 2 – Manufacture of Biological Products
Annex 3 – Manufacture of Radiopharmaceuticals
Annex 4 – Manufacture of (Non-Immunological) Veterinary Products
Annex 5 – Manufacture of (Immunological) Veterinary Products
Annex 6 – Manufacture of Medicinal Gases
Annex 7 – Manufacture of Herbal Medicinal Products
Annex 8 – Sampling of Starting and Packaging Materials
Annex 9 – Manufacture of Liquids, Creams and Ointments
Annex 10 – Manufacture of Inhalations
Annex 11 – Computerized Systems
Annex 12 – Use of Ionizing Radiation in Manufacturing
Annex 13 – Manufacture of Investigational Medicinal Products
Annex 14 – Manufacture of Blood Products
Annex 15 – Qualification & Process Validation
Annex 16 – Qualified Person (QP) & Batch Release: Applicable to EU only
Annex 17: Parametric Release
Annex 18: EMPTY (previously GMP standard for APIs)
Annex 19: Reference and Retention Samples
Annex 20: Quality Risk Management: Voluntary

Pharma Compliance (10 decks)

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