Quality Assurance and Quality Control

Question 1

Compare QA and QC

Answer 1

QA vs QC:
- Proactive vs Reactive
- Process vs Product oriented
- System vs Procedural
- Quality vs Verification Post manufacture
- Team vs Technical
- Documentation/audits vs Batch Inspection

Question 2

5 Key Components of GMP

Answer 2

1. Pure starting materials
2. Operationally ready premise/equipment
3. Competency of personnel
4. Latest technology
5. Documented Compliance to Processes

Question 3

Who overlooks the quality of medicines?

Answer 3

The International Conference on Harmonisation of Technical Requirements For Registration of Pharmaceuticals for Human Use (ICH)

Question 4

Sources of Impurities

Answer 4

1. Raw Materials
2. Manufacture methods
3. Atmospheric Contaminants
4. Manufacturing Hazards
5. Inadequate Storage

Question 5

What are limit tests and what do they determine?

Answer 5

Quantitative or semi-quantitative tests

To identify and control small quantities of impurities

Question 6

Types of limit tests

Answer 6

1. Comparison method (Semi-quantitative)
2. Total Ash method (Quantitative)

Question 7

List a few identification tests

Answer 7

1. Infrared Absorption Test
2. Ultraviolet Absorption Test
3. Thin Layer Chromatography

Question 8

List a few tests for quantification of APIs

Answer 8

Titrimetric Analysis
1. Direct Acid-base titration
2. Indirect titration
3. Back titration (Argentometric)

Question 9

What are primary standards and what are they used to determine?

Answer 9

Primary standards are stable chemical compounds that are available in high purity and that can be used to standardize the standard solutions used in titrations.

To determine correction factor

Question 10

What is correction factor? What do the values mean?

Answer 10

The correction factor (f) is usually used in volumetric analysis to simplify calculations. The factor is calculated as a ratio of (Actual concentration)/(Desired (or nominal) concentration). It tells us how much a given solution differs from the nominal (true) concentration.

f < 1 = Prepared solution is lower concentration than desired
f > 1 = Higher

Question 11

Indirect titration is used for?

Answer 11

a) Volatile substance (e.g. ammonia, volatile oil)
b) Insoluble substances (e.g. CaCO3)
c) Substances for which a quantitative reaction proceeds rapidly only in excess of a reagent (e.g. lactic acid)
d) Substances which require heating with a volumetric reagent during the determination in which a decomposition or loss of the reactants or products would occur in the process (e.g. aspirin)