What are the major problems experienced in practice of manufacturing process validation?
Responses were grouped into general problems and specific problems as follows: • General problems include lack of general understanding of validation principles such as the confirmatory aspects of validation, technical aspects of validation, and validation documentation. • Specific problems including determination of appropriate testing and sampling, general execution of validation, and change control. Additional discussion of responses was reported in JVT 12, #2 (February 2006) and JVT 12, #3 (May 2006). Discussions in JVT and on the website will be updated as new responses are received. 8. PROBLEMS WITH PROCESS VALIDATION — CLEANING PROCESS VALDATION Papers recently published in the Journal of Validation Technology have identified problems with various aspects of validation. In “Road Map for Equipment Cleaning Validation Within a Multi-Products manufacturing Facility,” Jose A. Morales Sanchez identified ten most common errors in his experience associated with cleaning validation. Tw
