WHAT IS PROCESS VALIDATION?
The process validation is derived from the fact that the specific exercise of process validation should never be designed to fail. Failure in carrying out the process validation assignment is often the result of an incomplete or faulty understanding of the process’s capability, in other words, what the process can and cannot do under a given set of operational circumstances. In a well-designed, well-run overall validation program, most of the budget dollars should be spent on equipment, components, facility, methods qualification, and process demonstration, formerly called process qualification.
Table 2 The Key Stages in the Product/Process Development Sequence
| Development stage | Pilot scale-up phase |
| Product design product characterizationProduct selection (“go” formula)Process design | 1 × batch size |
| Product optimization process characterization process optimization | 10 × batch size |
| Process demonstration Process validation program Product/process certification | 100 × batch size |
Except for solution products, the bulk of the work is normally carried out at 10 × batch size, which is usually the first scale-up batches in production-type equipment.
The U.S. FDA’s preapproval inspection program, wherein the applicant firm under either a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) submission must show the necessary CGMP information and qualification data (including appropriate development reports), together with the formal protocol for the forthcoming full-scale, formal process validation runs required before product launch.
Term validation has both a specific meaning and a general one, depending on whether the word “process” is used. the entire concept is discussed with the topic—i.e., design, characterization, optimization, qualification, validation, and/or revalidation.
Source & Reference-Drug and Pharmaceuticals Sciences (Volume 129)
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