Examples of Current Good Manufacturing Practices in a sentence
Each OBI facility has an FDA assigned Establishment Identification Number (FEIN) and is inspected by the FDA to evaluate Current Good Manufacturing Practices (CGMP) and compliance with relevant sections of 21 CFR 200, 600, 800 and 1200.
Class I devices are subject to general controls, such as labeling, pre-market notification and adherence to the FDA's Current Good Manufacturing Practices requirements set forth in the Quality System Regulation ("QSR"), which include testing, control and documentation requirements.
The Quality Technical Agreement will also address, without limitation, annual product reviews, returned goods, regulatory audits, compliance with Current Good Manufacturing Practices, and such other quality related concerns deemed appropriate.
Valeant will supply and distribute the Product to customers in accordance with the specifications and requirements set forth in the NDA approved by the FDA for sale of the Product in the Territory and all applicable laws, including without limitation the Act and all applicable rules and regulations thereunder, the NDA and Current Good Manufacturing Practices.
Maintain compliance with the requirements for risk-based preventative controls mandated by the Current Good Manufacturing Practices (CGMP’s) for the duration of contract term.