GMP Certification ConsultantsGMP Certification Consultants
Good manufacturing practice or GMP Certification is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP Certificate procedures, and have created their own GMP Certification guidelines that correspond with their legislation
The goal of GMP Accreditation is to ensure that products have consistent and controlled production according to quality standards. Companies must fulfill several requirements to get GMP certification.
GMP Certification Requirements by the World Health Organization (WHO)
A GMP certificate is a document certifying a specific product received an authorization for distribution in the consumer market and has passed quality standards set by the country where a company plans to distribute it. It ensures that the product or service meets standards and specific purposes for its production. WHO issues a COPP when the product in question is under consideration for a product license that will authorize its import and sale. Administrative action is required for renewal, extension, variation or review of such a license. Other documents needed are statement of licensing status, stability data, certificate of analysis, batch records for WHO GMP certification.
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