ABSTRACT
After the successful development of a product and its dossier submission to the respective regulatory bodies, the next step towards commercialisation of the product is process validation. Process validation is establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics. The concept of process validation was introduced 50 years ago by Byers and Loftus (Byers 1974; Loftus 1978), which was later drafted as a specific guideline by the US Food and Drug Administration (USFDA) in 1987 entitled ‘General Principles of Process Validation’. There have been paradigm shifts in terms of concept of process validation (Figure 8.1). In the past, the concept of process validation was conceived to represent consistency and reproducibility in manufacturing process conditions that were used for the development of a drug product without necessarily defining, understanding or controlling critical process parameters or critical product quality attributes. Thus, the inherent variability associated with the process remained unidentified. To overcome this issue, USFDA
8.1 Process Validation ........................................................................................ 237 8.1.1 Stage 1 (Process Design) ..................................................................240 8.1.2 Stage 2 (Process Qualification) ........................................................240
