In November 2008, the US Food and Drug Administration issued Draft Guidance for Industry—Process Validation: General Principles and Practices (1). The guidance outlines regulatory expectations for process validation following a "life-cycle concept" that describes a "cradle-to-grave" approach for validating pharmaceutical processes (2). The life-cycle approach builds upon the results of experimental activities during development to define operating parameters and product specifications that are used in initial and ongoing process qualification. The life-cycle concept provides a robust means for the development, manufacture, and control of pharmaceutical products.
The guidance document covers validation largely at a conceptual level and avoids narrow precepts and specific examples. This approach is appropriate because the document addresses the subject from active pharmaceutical ingredient (API) production (by either chemical synthesis or biological processes) through drug-product production for all pharmaceutical dosage forms. The intended breadth of coverage embraces a myriad of unit operations in the preparation and manufacture of these products. Unstated is whether the draft guidance is intended to be applied to supportive processes that are not an inherent part of the formulation process. Among the support processes are cleaning, inspection, sterilization, and aseptic processing. Each of these processes can be an essential part of pharmaceutical manufacture that requires validation.
Basics of the draft guidance