Common use of GMP Guidelines Clause in Contracts

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. The principles detailed in the US US, EU and ICH Current Good Manufacturing Practices (including 21 CFR 210 and 211) that govern the standards of manufacture for active pharmaceutical ingredientsany product intended for human use, as well as the product Guidance for Industry “Q7A Good Manufacturing Practice, Guidance for Active Pharmaceutical Ingredients”cGMP Guidelines, will govern (i) the standards of manufacture of the PRODUCTProducts, (ii) the product Product specifications, (iii) any applicable product license, and (iv) the NDA/ANDA application, pharmacopoeia or formulatory requirements.

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 ingredientsany product intended for human use, as well as the product Guidance for Industry “Q7A Good Manufacturing Practice, Guidance for Active Pharmaceutical Ingredients”cGMP Guidelines, will govern (i) the standards of manufacture of the PRODUCTProduct, (ii) the product specificationsProduct Specifications, (iii) any applicable product Product license, and (iv) the NDA/ANDA applicationMarketing Authorizations, pharmacopoeia pharmacopoeias or formulatory requirements.