Process validation cannot begin when the first commercial size batch is produced. It must start much earlier. In reality, process validation begins in the basic research stage. While basic research itself is not under Good Manufacturing Practices (GMPs), the results that are obtained there are critical to successfully completing the PV process. There is a lot of information that needs to be collected and organized prior to starting an effective process validation program. There are four major categories of documents that are needed for any successful process validation project. These are: Table 4.1 is a “wish list” of recommended documents and information that one should try to collect prior to starting the process validation. Many of these documents and drawings are critical to preparing the VMP. Others are needed for the protocols or SOPs. Be aware that each project is unique and not all documents are needed for every project. For example, the facility layout should also be available for the VMP so as to be able to show the paths that the materials and people will take in producing the product(s).
Getting Started (After the Equipment Specifications)
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