Intro to role of Inspector

Question 1

Compared to an actual medicinal product, counterfeits looks ______ than the real product

Answer 1

nicer/better

Question 2

Falsified medicines are medicinal products/APIs with ________________

Answer 2

false representation

Question 3

Do not judge the quality of medicinal product by its ________________-

Answer 3

appearance

Question 4

What is PIC/S?

Answer 4

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

Question 5

Compliance with _________________ is a pre-requisite for issuance and retention of manufacturer’s licence

Answer 5

PIC/S Good Manufacturing Practice (GMP) standard

Question 6

Outline the conventional Manufacturing Flow

Answer 6

1. Inputs (starting materials)
2. Production and packaging (processes)
3. QC testing (QC labs, document audit)
4. Output (Finished Dosage forms)

Question 7

State some objectives of warehouse inspection

Answer 7

1. Starting materials have approved specifications and purchased from approved suppliers
2. SOP in place for handling receipt, quarantine, sampling, materials and for handling rejected materials and products
3. Environment to preserve materials and products (E.g. temperature, pest control)

Question 8

Chapters in PICS guide to GMP on “Warehouse”?

Answer 8

• Chapter 3 (Premises: Storage Areas)

- Chapter 5 (Production: Starting Materials)

Question 9

Objectives of Weighing Room Inspection

Answer 9

1. Ensure Calibrated, Accurate and Reliable Weighing Balances used
2. Weighing Materials Correct ID, quantity and Quality
3. Authorised personnel wear PPE and Environment Weighing Room Controlled to prevent cross-contamination

Question 10

List some items covered during audit of weighing room

Answer 10

1. Weighing Balances (calibrated)
2. Starting materials (labelled)
3. Personnel (wear PPE)
4. SOP for weighing Method
5. Weighing room dust extraction system and Housekeeping

Question 11

Objectives of inspecting Production Department

Answer 11

1. Premises designed to prevent cross-contamination
2. Equipment cleaned and maintained
3. Control programmes such as PPE, and restricted access are implemented
4. Materials are of correct ID, quantity and quality
5. Process controls such as validated processes, in-process QCs and batch processing records

Question 12

Items/areas covered during inspection of Production Department, which are also covered in Packaging Room? (Hint: PMMMM)

Answer 12

1. Premises
2. Machine
3. Method
4. Materials
5. Manpower

Question 13

Objectives of inspecting QC Departments?

Answer 13

1. Ensure Analysts are trained properly, and there is an independent authority for Head of QC
2. QC Test Methods are approved by HSA, and are reliable for testing
3. Procedures such as maintenance, calibration, status labelling and assuring integrity are in place
4. Procedures in place for receipt, storage, security, record-keeping of test samples, reagents & reference standards

Question 14

Which chapter in PIC/S guide to GMP is about Quality Control?

Answer 14

6

Question 15

What are some areas/Items covered under inspection of QC labs?

Answer 15

1. Chem testing lab
2. Test samples
3. Prepped reagents
4. Reference Standards
5. Retention Samples
6. Test methods
7. Failure Investigation (for out of specification)
8. Stability Studies

Question 16

Name some other areas/activities that can be inspected?

Answer 16

1. Ancillary Premises (E.g. toilet, corridors, engineering workshops)
2. External Premises/Outsourced Activities (e.g. contract testing labs)

Question 17

Objectives of Documentation Audit?

Answer 17

1. Legal requirements complied
2. Regulatory Commitments to HSA complied
3. Manufacturing SOPs followed
4. Manufacturing Records are not falsified
   (i. e. Manufacturer conforms to legal & regulatory requirements and PIC/S GMP standard)

Question 18

Product Quality Review is covered in which chapter of PIC/S guide to GMP?

Answer 18

1

Question 19

Complaints and product recalls is covered in which chapter of PIC/S guide to GMP?

Answer 19

8

Question 20

Chapter 9 of the PIC/S guide to GMP covers _____

Answer 20

Self-inspection