This manual should then be the definitive authority on all Validation Online company matters. GAMP 5 compliance documents should be closely studied and the requirements, as applicable to your company’s activities, should be extrapolated and developed into your quality policies and procedures manual. So there is often contentious material, statements and or methods included. Only difference is it will have titled them, Company Regulatory Practices and Procedures (CRPP) (or something similar), and they will be specific to the company.Īll the GAMP 5 guidance documents have been authored by committees, and not everybody in a committee can get their own say. However the reality of the situation is that our regulatory requirements for cGMP are published in 21 CFR Part 820/210/211/11 and other government issued edicts.Ī company compliant with its regulatory requirements will have written its own equivalent of the GAMP 1/2/3/4/5 series. Although GAMP 5 has no legal standing and is purely advisory, it does contain information and methodologies that are of interest to anyone engaged in validation activities within the cGMP regulated environment. The acronym GAMP 5 refers to "Good Automatic Manufacturing Practices issue 5", document.
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