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Control of Liquid Preparations

FAR421 Good Manufacturing Practice and Quality Assurance

Nina Khan

on 17 April 2014

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Transcript of Control of Liquid Preparations

Can be adversely affected by
Tests described in pharmacopoeia related to microbial contamination
Even more alarming is the increase in drug recalls due to microbial contamination, which are among the most dangerous as they can result in serious illness or death.
Karla Fjeld, Microbiologics Inc.
Quality Control Tests
Quality Control Test
Microbial Limit Test
Preservative Efficacy Test / Efficacy of Antimicrobial Preservation
Antibiotic efficacy test
Monday, February 17, 2014
Vol XCIII, No. 311
Some parts of the pharmaceutical process relating to quality of products
Safety, efficacy, quality
Tests described in pharmacopoeia and others related to chemical and
physical stabilities
Quality Control Test
Stability studies
Control of Liquid Preparations
Test described in pharmacopoeia related to antibiotics as a product
Microorganisms causing spoilage
Other factors causing degradation and decomposition
USP Chapter 81 :
Antibiotics - Microbial Assays
BP Appendix XIV A:
Microbiological assay of antibiotics
Need to use approved reference cultures and antibiotics
Full transcript