"Science Behind the Best Health"

Audit Questions

Audit Questions

Most common audit questions:

  • To what extent is company required to validate a given system, method or process?  including process validation, laboratory method validation, cleaning validation, and Computer systems Validation (CSV).  

  • How does one interpret FDA guidance, cGMP’s (current Good manufacturing Practices) the CFR’s (Code of Federal Regulations), or the USP (United States Pharmacopoeia)?  

  • How does a company prepare for a PAI (Pre-approval inspection)?  

  • How does a company handle a regulatory inspection?  How do we prepare?  What are we obligated to reveal?  When can we object to revealing information? 

  • How does a company formally respond to FDA comments following inspection?

  • How can we speed up development of a product and still be compliant in the eyes of the regulatory bodies? 

  • How does a company conduct effective investigations in the laboratory?   

  • How does a company conduct investigations in manufacturing environment? 

  • How does a company audit a supplier?  What is vendor qualification process? 

  • What is CAPA (Corrective And Preventive Actions) and when to apply it? 

  • How should complaints be handled?  

  • How does a company implement and run a stability program?  

  • How does one perform a Pharmaceutical Quality Audit?   

  • How does a company comply with 21CFR11, Electronic Records and Signatures? 

  • How does a company place a pharmaceutical excipient ingredient in a reduced testing program?  Can we do the same for a pharmaceutical active ingredient? 

  • Does a company have to validate the stability of solutions utilized in the laboratory? How is this done? 

The following questions and any other questions related to specific audit situations can be answered at our seminars






















































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