Guide to Cleaning Validation in API plants This Guideline has been produced by the Active Pharmaceutical Ingredients Committee(APIC) Working group.Different organizations will be influenced by their companies and the markets that theyserve in the approaches that they take and the policies that they have with respect tothe subject.It is also valuable to bear in mind that this is an area that is changing rapidly and whatwas considered as being acceptable 2-5 years ago is now not adequate. Therefore,companies should be aware of the need to continuously update themselves on currentregulatory requirements.
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As defined by regulatory standards, validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.
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