GMP guidelines

Explain how you handle and document changes to product labeling and packaging.

Show us your procedures for maintaining and documenting environmental monitoring in manufacturing areas.

Can you demonstrate how you monitor and maintain the quality and purity of incoming raw materials?

How do you ensure the integrity of electronic records and electronic signatures?

Walk us through your process for handling and documenting employee training records.

Describe your process for conducting internal audits and how you address findings.

How do you ensure that your products meet FDA requirements for identity, strength, quality, and purity?

Explain your process for validating analytical methods used in quality control.

Show us examples of your corrective and preventive action (CAPA) processes and how they’ve been implemented.

Provide examples of how you communicate with regulatory authorities, including the FDA, in the event of an audit or inspection.