5 key components of Good Manufacturing Practice (GMP)
- Raw/ starting materials must be pure.
- Premises and equipment must be maintained for operational readiness.
- People involved in the manufacturing process must be trained to competent level.
- The manufacturing procedures must use the latest technology and science.
- Processes must be documented to show compliance.
List the sources of impurities exposed to pharmaceutical manufacturing
- Raw Materials
- Method of Manufacture
- Atmospheric Contaminants
- Manufacturing Hazards
- Inadequate Storage
Is GMP mandated by law?
No.
Types of limit test
Semi-quantitative (comparison method) or quantitative
Purpose of limit test
to identify and control small quantities of impurity which may be present in the drug substance.
Infrared absorption relates to ____ and____ of bonds in different functional groups to the structure of the analyte.
stretching; bending
Purpose of Infrared absorption test
Identify fg
Purpose of primary standard
used to standardize the standard solutions used in titrations.
Type of Titrimetric Analysis for Aspirin
indirect/ Back Titration
In Argentometric Titration, ____ reacts with potassium chromate (indicator) where a___ colouration indicates the end point.
excess silver nitrate; red
