GMP Guidelines Clause Samples
The GMP Guidelines clause establishes the requirement for parties to adhere to Good Manufacturing Practice (GMP) standards in the production or handling of goods. This clause typically applies to manufacturers, suppliers, or contractors involved in producing pharmaceuticals, food, or other regulated products, ensuring that all processes meet recognized quality and safety benchmarks. By mandating compliance with GMP, the clause helps maintain product integrity, reduces the risk of contamination or defects, and ensures regulatory compliance, thereby protecting both consumers and the contracting parties.
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GMP Guidelines. The premises, equipment and systems used to manufacture and release the Product must be in compliance with all applicable GMP requirements for APIs, including the principles detailed in the US Code of Federal Regulations, Parts 11, 210, 211, and ICH Q7 GMP Guide for APIs, as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member slates of the PIC scheme.
GMP Guidelines. 5.3.1 The principles detailed in the US Current Good Manufacturing Practices (21 CFR 200, 211, and 600) and the Rules Governing Medicinal Product in The European Community—Volume IV Good Manufacturing Practice for Medicinal Products Guidelines will cover the standards of manufacture of the PRODUCTS, as well as, the product specifications and any applicable product license or pharmacopoeia or formulatory requirements.
GMP Guidelines. 5 5.4 Materials............................................. 5 5.5
GMP Guidelines. The principles detailed in the US Current Good Manufacturing Practices (21 CFR 210 and 211) that govern the standards of manufacture for active pharmaceutical ingredients, as well as the product Guidance for Industry “Q7A Good Manufacturing Practice, Guidance for Active Pharmaceutical Ingredients”, will govern (i) the standards of manufacture of the PRODUCT, (ii) the product specifications, (iii) any applicable product license, and (iv) the NDA/ANDA application, pharmacopoeia or formulatory requirements.
GMP Guidelines. Any applicable product license or pharmacopoeia requirements applicable to the Manufacture of Product(s) shall be complied with in addition to cGMP and Specifications.
GMP Guidelines. The cGMP guidelines to be applied are the United States cGMPs listed in 21 Code of Federal Regulations (CFR) Parts 11 Electronic Records, 200, 210, and 211 and associated Compliance Guidances.
GMP Guidelines. 3 5.4 MATERIALS...................................................3 5.5 MASTER PRODUCTION RECORDS...................................4
GMP Guidelines. Any applicable API license or pharmacopoeia or formulatory requirements applicable to the Manufacture of APIs shall be complied with in addition to cGMP, Q7A, and Specifications.