Product Quality and Safety

Role of GMP in preventing contamination

Mastering GMP : Five Pillars of Pharmaceutical Quality

GMP v/s cGMP

Can you provide an overview of your quality management system (QMS) and how it ensures compliance with FDA regulations?

How are employees trained on FDA regulations and guidelines relevant to their roles?

Can you demonstrate how your documentation practices ensure accuracy, traceability, and completeness?

How do you maintain and calibrate critical equipment used in your manufacturing process?

Show us your facility’s organization, cleanliness, and measures for preventing cross-contamination.

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.