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PR3145 > Lecture 1 Role of Pharmaceutical Inspector in regulating medicinal products > Flashcards

Lecture 1 Role of Pharmaceutical Inspector in regulating medicinal products Flashcards

1
Q

What are some things that can be falsified for medicinal products/APIs?

A
  1. Name of Manufacturer
  2. Name of Market Authorization Holder
  3. Batch Number
  4. Packaging/Labeling
  5. Identity/Composition
  6. Manufacturing Records/Certificates of Analysis
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2
Q

Who can make contaminated medicinal products?

A
  • Licensed Manufacturers (unwittingly) when producing multiple products using multi-purpose equipment in facilities lacking cross-contamination control program
  • Backyard Manufacturers
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3
Q

Is it possible to judge the quality of a medicinal product by its appearance or presentation?

A

No

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4
Q

What do consumers trust the regulators to do?

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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5
Q

Under Singapore Medicines Act/Health Products Act, what is required for manufacture of medicinal products (therapeutic products)?

A

Manufacturer’s Licence

- Compliance with PIC/S GMP standard is pre-requisite for issuance and retention of Manufacturer’s Licence

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6
Q

How often are GMP compliance audits conducted?

A

Periodic audits (18-36 months frequency)

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7
Q

When did Singapore join the PICS?

A

1 Jan 2000 as the 1st Asian Member

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8
Q

What is PICS?

A

Pharmaceutical Inspection Co-operation Scheme

- based in geneva consisting of countries with high standard inspection systems

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9
Q

What is the latest version of PICS guide?

A

Version 14 dated July 2018

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10
Q

What is GMP?

A

Good Manufacturing Practices

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11
Q

Purpose of GMP?

A

Ensure a medicinal product is consistently manufactured and controlled, its quality is appropriate for use as per market authorization (product license)

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12
Q

How many chapters are there for the PICS GMP standard?

A

9

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13
Q

What is the goal of PICS?

A

“To lead the international development, implementation and maintenance of Harmonised GMP Standard (for Manufacturers) and Quality System (for Inspectorates) in the field of medicinal products”

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14
Q

What do the PICS chapters comprise of?

A
  1. Pharmaceutical Quality System (including Product Quality Review and Quality Risk
  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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15
Q

Where do we inspect the starting materials? (APIs, Excipients and Packaging Materials)

A

Warehouse

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16
Q

What is the flow of on-site inspection?

A
  1. Warehouse
  2. Weighing room/Production areas/Packaging Room
  3. QC labs
  4. Document audit
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17
Q

What are the 3 objectives of warehouse inspection?

A
  1. Starting materials and finished products are approved
  2. SOPs in place
  3. Environment of warehouse
18
Q

What is/are the relevant PICS GMP chapter(s) for warehouse inspection?

A
  • Chapter 3 (Premises : Storage Areas)

- Chapter 5 (Production : Starting Materials)

19
Q

What are the objectives of weighing room inspection?

A
  1. Calibrated, Accurate and Reliable weighing balances used
  2. Weighed materials are of correct identity, quantity and quality
  3. Environment and authorized personnel in PPE to prevent cross contamination
20
Q

What is/are the relevant PICS GMP chapter(s) for weighing room inspection?

A

Chapter 5 (Production : Dispensing)

21
Q

What are the 5 objectives of Production room inspection?

A
  1. Premises designed for prevention of cross-contamination
  2. Effective cleaning of equipment and regular maintenance
  3. Personnel control programs (PPE and restricted access)
  4. Materials of correct identity, quantity and quality
  5. Process Controls (Validation/revalidation, In-process QC, batch processing records in place)
22
Q

What is/are the relevant PICS GMP chapter(s) for production room inspection?

A

Chapter 5 (Production : Paragraphs 5.1 to 5.71)

23
Q

What are the Items/Areas Covered during Inspection of Production Department?

A

PMMMM

  • Production rooms (Premises)
  • Production equipment (Machine)
  • Production process (Method and starting Materials)
  • Personnel (Manpower)
24
Q

What are the objectives of QC department inspection?

A
  1. Properly trained analysts available with independent authority for head of QC
  2. Approved QC methods with Analytical Method Validation and Routine QC Test Results
  3. SOPs are in place (Maintenance, Calibration, Status Labeling and Assuring Integrity of QC Test Equipment, Receipt, Storage, Security, Record keeping of Test Samples, Reagents and Reference Standards)
25
Q

What is covered under inspection of the chemistry testing laboratory?

A
  • Test samples
  • Prepared Reagents
  • Reference standards (chemical)
  • Retention Samples (for stability or regulatory testing)
  • Test Methods
  • Failure Investigation (Out-of-Specification - OOS)
  • Stability Studies
26
Q

What are some of the other areas/activities inspected?

A
  • Ancillary premises (Engineering workshop, Rest room and corridors)
  • External Premises/outsourced activities (contract testing laboratories)
27
Q

What are the 4 objectives of Document audit?

A
  1. Legal requirements under Medicines and Health products act are complied
  2. Regulatory Commitments to HSA are Complied by Manufacturer
  3. Manufacturing SOPs, including those on Product Quality Reviews, Handling of Complaints and Recalls and Self Inspection, are followed
  4. Manufacturing Records are Authentic No Falsification of Data
28
Q

What are the areas covered under documentation audit?

A
  • Document control system
  • SOP and Records on Pest Control, Temperature/ humidity monitoring
  • Batch Manufacturing records
  • Stability testing program
  • Process validation program
  • GMP training program
  • SOP and Records on Product quality review
  • SOP and Records of Product complaints and Recalls
  • SOP and Records of Self-Inspection (IQA) program
29
Q

How should Product Quality Review (PQR) results be used?

A

PQR results trended , investigated with CAPAs taken based on Root Cause Analysis

30
Q

How should the complaint department be set up?

A
  • Designated person to handle complaints and decide on actions to take
  • Written SOP on handling complaints
  • All complaints are recorded, investigated and closed out with decisions taken documented
  • All complaint records should be reviewed regularly for any recurring trend
  • HSA to be notified if a product recall is made by the manufacturer
31
Q

Who should manufacturer notify if they are considering a product recall?

A
  • The Competent Authority (Regulatory Authority) should be notified, for all the countries the product is sold in
32
Q

Who should coordinate and execute product recalls?

A

A designated person , independent of Sales and Marketing, should be responsible for coordinating and executing recalls

33
Q

What are the documents needed in a product recall?

A
  1. Written SOP
  2. Distribution Records
  3. Progress of recall process should be recorded and final report issued, including a reconciliation between delivered and recovered products
34
Q

What is done with the recalled product?

A

Recalled product should be stored securely while awaiting decision on its fate

35
Q

What should be done with the recall procedure?

A

Effectiveness of recall procedure should be evaluated regularly

36
Q

What are the areas covered during self-inspection?

A

The areas covered during self inspection should include production, QC, premises, equipment, personnel, documentation, etc (i.e. all 9 chapters
and relevant annexes of PICS GMP standard)

37
Q

Who should conduct self-inspections?

A
  • 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
38
Q

What are the documentation necessary for self-inspections?

A
  • All self inspections should be recorded , covering observations made during inspections and proposed CAPAs
  • Statement(s) of eventual action(s) taken should also be recorded
39
Q

How often should self-inspections be conducted?

A

Self Inspections should be carried out at periodic intervals in accordance with pre arranged program

40
Q

Which of the chapters/annexes of the PICS GMP standard are mandatory?

A

The 9 chapters are mandatory but not all annexes are mandatory (i.e. 4, 5, 16, 20 in SG)
annex 4: manufacture of non-immunological veterinary pdts
annex 5: manufacture of immunological veterinary pdts
annex 16: qualified person and batch release
annex 20: quality risk management

41
Q

Which annexes are not implemented in SG?

A

Annex 4 - Manufacture of (Non Immunological ) Veterinary Products
Annex 5 - Manufacture of (Immunological) Veterinary Products
Annex 16 - Qualified Person (QP) and Batch Release : Applicable to EU Only
Annex 20 - Quality Risk Management : Voluntary

PR3145 (10 decks)

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