GMP guidelines

Explain your process for handling and documenting deviations from established procedures.

Provide examples of risk assessments you’ve conducted on your processes, products, and suppliers.

How do you manage and document changes to processes, equipment, or materials?

Walk us through your procedure for investigating and addressing customer complaints related to product quality.

Can you show us how you handle and document product recalls, if necessary?

Describe your supplier qualification process and how you ensure their compliance with FDA requirements.

Show us examples of how you maintain and validate computer systems used in your manufacturing and quality processes.

Demonstrate your procedures for conducting batch record reviews and ensuring their accuracy.

How do you handle and document the disposal of non-conforming materials or products?

Provide an overview of your process validation procedures for critical manufacturing processes.