The document properly places process equipment in a secondary role. Equipment qualification is certainly expected, but only as a means to support the process and not as the focus of the effort or an end in itself. Providing clarity in this regard is an important step forward and is consistent with FDA's risk-based compliance objective, the recent American Society for Testing and Materials effort at refocusing equipment qualification activities, and industry publications that cite the need for focus on critical end-product quality concerns (6–8).
In summary, the usefulness of the draft guidance for validating pharmaceutical production processes and products is unquestionable. The life-cycle model will result in development and validation exercises that provide relevant and meaningful information. The link between the process parameters that influence the critical quality attributes will serve the industry well. The use of statistical methods will add a rigor to the validation efforts that has been sorely lacking.
- Critical process utilities (e.g., water systems and compressed gases)
- Classified and controlled environments (e.g., ISO 5–8 rooms and cold boxes)
- Computerized systems (e.g., process control and manufacturing resource planning)
- Inspection of product attributes (e.g., visible particle and labeling)
- Cleaning and preparation procedures (e.g., product-contact parts and surfaces)
- Sterilization processes (e.g., steam, dry heat, and radiation)
- Aseptic processing (e.g., filling and compounding)
- Manual procedures (e.g., gowning and sanitization).
The ease with which the guidance can be applied varies substantially with the particular process, and each general category is best considered individually.