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The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production.

"Independent verification and validation" can be abbreviated as "IV&V". In the post-development phase, verification procedures involve regularly repeating tests devised specifically to ensure that the product, service, or system continues to meet the initial design requirements, specifications, and regulations as time progresses.Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.Pardon the alphabet soup, but these acronyms identify common terms that you’ll see in many FDA and Health Canada guidance documents, and typically refer to equipment. OQ is Operational Qualification and PQ is Performance Qualification.Before you even get to IQ, OQ, PQ, if you’re acquiring a new piece of equipment, you’ll need design specifications that define exactly what’s in that piece of equipment.

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