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?