GMP Regulations

Health Canada

Pharmaceutical and Medical Devices Agency (PMDA)

European Medicines Agency

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?