Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Compliance > sia > Flashcards

sia Flashcards

1
Q

Medicinal Products/APIs with false representation

A

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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

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

A
  • To weed out adulterated, counterfeits & falsified products
  • To ensure safe, efficacious & quality products
  • To oversee drug/API manufacturing & supply chain
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

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

A
  • To wisely regulate health products

- To safeguard public health

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

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

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Limitations of Conventional Product Testing

A
  • 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.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

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

A
  • 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.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

quality of medicine/health product has to include

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

PIC/S GMP how many chapters and annexes

A

9 chapters

20 annexes ——> annex 18 is empty

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Pharmaceutical quality system chapter

A

1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

personnel chapter

A

2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

premises and equipment chapter

A

3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

documentation chapter

A

4

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

production (including packaging) chapter

A

5

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

quality control chapter

A

6

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

outsource activity chapter

A

7

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

complaints and product recall chapter

A

8

17
Q

self inspection chapter

A

9

18
Q

sterile product annex

A

1

19
Q

biological product annex

A

2

20
Q

radiopharmaceuticals annexx

A

3

21
Q

vet product nonimmunologiical annes

A

4

22
Q

vet product immunologiical annes

A

5

23
Q

medicinal gases annex

A

6

24
Q

herbal annex

A

7

25
Q

sampling annex

A

8

26
Q

liquid creams and ointment annesx

A

9

27
Q

inhalation annex

A

10

28
Q

computerised system annex

A

11

29
Q

ionizing radiaiton annex

A

12

30
Q

investigational medicinal products annex

A

13

31
Q

blood product annes

A

14

32
Q

process validation annex

A

15

33
Q

qualified person applicable to EU only annex

A

16

34
Q

parametric release annex

A

17

35
Q

empty annex

A

18

36
Q

retention sample annex

A

19

37
Q

quality risk management annex

A

20

38
Q

intrinsic contaminants

A

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
  1. impurities from primary container and labels
39
Q

extrinsic contaminants

A

originate externally from

production personnel
processing equipment
packaging equipment
manufacturing premises (env)

often non-specific in nature.

Compliance (6 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions