Tag: process validation iq oq pq

Periodic Review and Requalification of Vendors and Materials

Periodic Review and Requalification of Vendors and Materials Periodic Review and Requalification of Vendors and Materials The effectiveness and reliability of the pharmaceutical manufacturing process are highly dependent on the quality of the vendors and materials used. Therefore, periodic review…

Establishing MACO and PDE Values for Shared Equipment

Establishing MACO and PDE Values for Shared Equipment Establishing MACO and PDE Values for Shared Equipment Step 1: Understanding the Basics of MACO and PDE The determination of Maximum Allowable Carryover (MACO) and Permissible Daily Exposure (PDE) values is critical…