August 30, 2021: Pharmaceutical Interview Questions and Answers

#Prefiltration Bioburden #AlternateMicrobiologicalTestMethods #HowParticleMonitoringIsUseful #EnvironmentalConditionofSterilityTestingArea #SterilityTesting

1. Why controlling of Prefiltration Bioburden is important?

Manufacturing process controls should be designed to minimize the bioburden in the unfiltered product. In addition to increasing the challenge to the sterilizing filter, bioburden can contribute impurities (e.g., endotoxin) to, and lead to degradation of, the drug product. A prefiltration bioburden limit should be established.

2. In which scenario alternate Microbiological Test Methods should be used?

Other suitable microbiological test methods (e.g., rapid test methods) can be considered for environmental monitoring, in-process control testing, and finished product release testing after it is demonstrated that the methods are equivalent or better than traditional methods (e.g.,USP).

3. How Particle Monitoring is useful in clean room?

Routine particle monitoring is useful in rapidly detecting significant deviations in air cleanliness from qualified processing norms (e.g., clean area classification).

4. What should be the environmental condition of sterility testing area?

The testing laboratory environment should employ facilities and controls comparable to those used for aseptic filling operations. Poor or deficient sterility test facilities or controls can result in test failure. If production facilities and controls are significantly better than those for sterility testing, the danger exists of mistakenly attributing a positive sterility test result to a faulty laboratory even when the product tested could have, in fact, been nonsterile.

5. Which USP chapter and which part of 21 CFR describe about sterility testing?

Sterility testing methods are required to be accurate and reproducible, in accordance with 211.194 and 211.165.

USP <71> “Sterility Tests” is the principal source used for sterility testing methods, including information on test procedures and media.

Reference: FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice – September 2004

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