Question 4 (a) Microbiological contamination can be problematic for the pharmaceutical manufacturing industry. Describe BOTH strategies employed in the pharmaceutical industry to ensure acceptable microbiological stability. (b) Outline ANY FOUR specific sections that are clearly defined in stability testing protocols and name ANY TWO stability indicating analytical tests that are performed during stability testing. (c) Briefly discuss ANY TWO high stress/challenges that are utilised during an accelerated stability testing study. (d) Discuss how the shelf-life of a pharmaceutical drug formulation can be predicted.

Question 4 (a) Microbiological contamination can be problematic for the pharmaceutical manufacturing industry. Describe BOTH strategies employed in the pharmaceutical industry to ensure acceptable microbiological stability. (b) Outline ANY FOUR specific sections that are clearly defined in stability testing protocols and name ANY TWO stability indicating analytical tests that are performed during stability testing. (c) Briefly discuss ANY TWO high stress/challenges that are utilised during an accelerated stability testing study. (d) Discuss how the shelf-life of a pharmaceutical drug formulation can be predicted.

Biomedical Instrumentation Systems

1st Edition

ISBN:9781133478294

Author:Chatterjee

Publisher:Chatterjee

Chapter21: Regulation And Standards

Section: Chapter Questions

Problem 10Q

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