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Question 1

Medicinal Products/APIs with false representation

Answer 1

These may include falsified:

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

Question 2

Consumers put their Trust in Manufacturers & Suppliers and also in the Regulators/Inspectors.
to

Answer 2

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

Question 3

(1) Role of HSA as a (Health Product) Regulatory Agency

Answer 3

• To wisely regulate health products

- To safeguard public health

Question 4

GMP aims to build quality into a product at all stages of its manufacture from:

Answer 4

• Design of medicinal product (formulation of dosage form)
• Procurement/QC of starting materials
• Production of intermediate/bulk products & IPQC
• Filling/packaging/labeling of finished product
• Final QC testing of finished product before release

Question 5

Limitations of Conventional Product Testing

Answer 5

• You test only a “representative” sample size
• You can test only if you know the analyte and you have a test method
• You can test only if test method is specific, accurate and reliable, i.e if it is validated.

Question 6

A Medicinal Product is fit for its intended purpose, if:

Answer 6

• It is the right product (made according to a predetermined formula and method)
• It is of the right strength, in the right container and correctly labelled.
• Free from contamination
• Not deteriorated or broken down
• Properly sealed in its container and protected against damage and contamination
• Consistently of the quality specified by the manufacturer and approved by the regulator.

Question 7

quality of medicine/health product has to include

Answer 7

• Identity (of starting material)
• Potency (of starting material, especially active pharmaceutical ingredients)
• Purity (freedom from contaminants and impuriries)
• Pharmaceutical Quality Attributes (of finished dosage form)
  o Hardness, Friability, particle size, dissolution profile, pH, clarity, Color index, Microbial limits, sedimentation rate, viscosity, sterility, Endo-toxin levels
• Stability, homogeneity

Question 8

PIC/S GMP how many chapters and annexes

Answer 8

9 chapters

20 annexes ——> annex 18 is empty

Question 9

Pharmaceutical quality system chapter

Answer 9

1

Question 10

personnel chapter

Answer 10

2

Question 11

premises and equipment chapter

Answer 11

3

Question 12

documentation chapter

Answer 12

4

Question 13

production (including packaging) chapter

Answer 13

5

Question 14

quality control chapter

Answer 14

6

Question 15

outsource activity chapter

Answer 15

7

Question 16

complaints and product recall chapter

Answer 16

8

Question 17

self inspection chapter

Answer 17

9

Question 18

sterile product annex

Answer 18

1

Question 19

biological product annex

Answer 19

2

Question 20

radiopharmaceuticals annexx

Answer 20

3

Question 21

vet product nonimmunologiical annes

Answer 21

4

Question 22

vet product immunologiical annes

Answer 22

5

Question 23

medicinal gases annex

Answer 23

6

Question 24

herbal annex

Answer 24

7

Question 25

sampling annex

Answer 25

8

Question 26

liquid creams and ointment annesx

Answer 26

9

Question 27

inhalation annex

Answer 27

10

Question 28

computerised system annex

Answer 28

11

Question 29

ionizing radiaiton annex

Answer 29

12

Question 30

investigational medicinal products annex

Answer 30

13

Question 31

blood product annes

Answer 31

14

Question 32

process validation annex

Answer 32

15

Question 33

qualified person applicable to EU only annex

Answer 33

16

Question 34

parametric release annex

Answer 34

17

Question 35

empty annex

Answer 35

18

Question 36

retention sample annex

Answer 36

19

Question 37

quality risk management annex

Answer 37

20

Question 38

intrinsic contaminants

Answer 38

present inherently in APIs, excipients (including water) and packaging materials used in formulating product not removed competely from starting and packaging materials during their manufacturing processes referred to as impurities - often specific in nature. 1. Process-related impurities (during synthesis of API) • Un-reacted API starting material/intermediates • Residual reagents and catalysts • Residual solvents • Residual heavy/other metals • By-products. 2. Drug-related impurities • Degradation products (after API is formed) ``` 3. polymorphs • Ampicillin • carbamazepines • cimetidine • mefenamic acid • omeraprazole • ranitidine HCL ``` ``` 4. stereo-isomers • Dopamine • propranolol • Dex-chlorpheniramine • guaifenesin • lisinopril dihydrate ``` 5. impurities from primary container and labels

Question 39

extrinsic contaminants

Answer 39

originate externally from production personnel processing equipment packaging equipment manufacturing premises (env) often non-specific in nature.