August 27, 2021: Pharmaceutical Interview Questions and Answers

#DisinfectantsEffectiveness #IPAIneffectiveAgainst #AdequacyOfDisinfectantProgram

1. How the suitability of disinfecting agents and procedure for disinfection is assessed?

The effectiveness of these disinfectants and procedures is measured by their ability to ensure that potential contaminants are adequately removed from surfaces.

2. How disinfectants should be handled and maintained to prevent contamination in the aseptic facility?

To prevent introduction of contamination, disinfectants should be sterile, appropriately handled in suitable (e.g., sterile) containers and used for no longer than the predefined period specified by written procedures.

3. 70 percent isopropyl alcohol is ineffective against which spores?

70 percent isopropyl alcohol is ineffective against Bacillus spp. spores.

4. To have a sound disinfectant program for aseptic area what types of disinfectant must have to be added?

To have sound disinfectant program a sporicidal agent should be included.

5. How the adequacy of disinfectant program can be assessed?

The adequacy disinfectant program shall be evaluated using a routine environmental monitoring program. If indicated, microorganisms associated with adverse trends can be investigated as to their sensitivity to the disinfectants employed in the cleanroom in which the organisms were isolated.

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

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