Current Good Manufacturing Practices
Current Good Manufacturing Practices. Shall mean current Good Manufacturing Practice as set forth by the US FDA as well as current good manufacturing practices applicable to the API, or the making thereof at HOVJONE's manufacturing facility, set forth by the relevant Regulatory Agency.
Found in
Intersect ENT, Inc. contract
Current Good Manufacturing Practices. The current good manufacturing practices applicable to the manufacture of sterile pharmaceutical products for human use in the United States, as set forth in regulations promulgated by the FDA
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ACHIEVE LIFE SCIENCES, INC. contract
Current Good Manufacturing Practices. Current Good Manufacturing Practices as defined from time to time during the Term by the Act and related regulations or any successor laws or regulations (including without limitation 21 C.F.R. Parts 210 and 211) governing the Manufacture, handling, storage, testing and control of the Material in the United States and any other applicable Regulatory Authority
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ONYX PHARMACEUTICALS INC contract
Current Good Manufacturing Practices. The standards established by the FDA for current Good Manufacturing Practices, as specified in the International Pharmaceutical Excipients Council (IPEC) and the Pharmaceutical Quality Group (PQG) for current Good Manufacturing Practices for Pharmaceutical Excipients, as specified in the 2006 Guide (or their successor provisions), as any of the foregoing may be amended from time to time.
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Flexion Therapeutics Inc contract
Current Good Manufacturing Practices. Or "cGMP" means the applicable current good manufacturing practices promulgated by the FDA or other applicable Regulatory Agency in any region or country other than the United States, including any applicable requirements of Title 21 of the Code of Federal Regulations.
Current Good Manufacturing Practices. Or cGMP means the methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug or API to assure that such drug or API meets the regulatory requirements of the FDA and as further defined in 21 C.F.R.
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MANNKIND CORP contract
Current Good Manufacturing Practices. Or "cGMP" means the methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug or API to assure that such drug or API meets the regulatory requirements of the FDA and as further defined in 21 C.F.R. Parts 210 and 211 and the guidance of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research and the European Commission Directive 2003/94/EC of October 8, 2003.
All Definitions
Found in
Amphastar Pharma contract