Common use of GMP Guidelines Clause in Contracts

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.

Appears in 2 contracts

Sources: Supply Agreement (Jazz Pharmaceuticals Inc), Supply Agreement (Jazz Pharmaceuticals Inc)

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—Community - Volume IV Good Manufacturing Practice for Medicinal Products Products" and/or World Health Organization's cGMP 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.

Appears in 2 contracts

Sources: Toll Manufacturing and Packaging Agreement (Cephalon Inc), Toll Manufacturing and Packaging Agreement (Cephalon Inc)

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—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.

Appears in 1 contract

Sources: Supply Agreement (Pozen Inc /Nc)