IC12

Question 1

5 key components of Good Manufacturing Practice (GMP)

Answer 1

1. Raw/ starting materials must be pure.
2. Premises and equipment must be maintained for operational readiness.
3. People involved in the manufacturing process must be trained to competent level.
4. The manufacturing procedures must use the latest technology and science.
5. Processes must be documented to show compliance.

Question 2

List the sources of impurities exposed to pharmaceutical manufacturing

Answer 2

• Raw Materials
• Method of Manufacture
• Atmospheric Contaminants
• Manufacturing Hazards
• Inadequate Storage

Question 3

Is GMP mandated by law?

Answer 3

No.

Question 4

Types of limit test

Answer 4

Semi-quantitative (comparison method) or quantitative

Question 5

Purpose of limit test

Answer 5

to identify and control small quantities of impurity which may be present in the drug substance.

Question 6

Infrared absorption relates to ____ and____ of bonds in different functional groups to the structure of the analyte.

Answer 6

stretching; bending

Question 7

Purpose of Infrared absorption test

Answer 7

Identify fg

Question 8

Purpose of primary standard

Answer 8

used to standardize the standard solutions used in titrations.

Question 9

Type of Titrimetric Analysis for Aspirin

Answer 9

indirect/ Back Titration

Question 10

In Argentometric Titration, ____ reacts with potassium chromate (indicator) where a___ colouration indicates the end point.

Answer 10

excess silver nitrate; red