Process performance qualification protocol

Process Performance Qualification (PPQ) Protocol is a critical component of the validation process in manufacturing, particularly in regulated industries such as pharmaceuticals, biotechnology, and medical devices. Its primary goal is to ensure that manufacturing processes consistently produce products that meet predetermined specifications and quality attributes. ### Key Components of PPQ Protocol 1. **Objective:** The main objective of the PPQ is to demonstrate that the manufacturing process can perform as intended in terms of product quality and consistency under commercial conditions.