Pharmaceutical current good manufacturing practice

In 2002, the FDA announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century . The purposes of this... 

US Food and Drug Administration, Pharmaceutical current good manufacturing practices (cGMPs) for the 21st century - a risk-based approach final report, 2004. 

Draft Guidance for Industry Quality System Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. FDA, September 2004. 

GUIDANCE FOR INDUSTRY QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS... 

The dual application of PHS Act requirements (licensing of products and establishments in accordance with 42 ET.S.C. 262, PHS Act section 351) as well as the pharmaceutical current good manufacturing practice (cGMP) regulations derived from the Food, Drug and Cosmetic Act (FD C Act)(21 U.S.C. 374)... 

Lactic acid is generally recognized as safe (GRAS) for multipurpose food use. Lactate salts such as calcium and sodium lactates and esters such as ethyl lactate used in pharmaceutical preparations are also considered safe and nontoxic (7). The U.S. Food and Dmg Administration fists lactic acid (all isomers) as GRAS and sets no limitations on its use in food other than current good manufacturing practice (46). 

Two similar dosage forms, eg, tablets, that contain the same amount of the same dmg entity and meet USP/NF and current good manufacturing practices (FDA) are referred to as pharmaceutical equivalents (PE). When, upon adiriinistration, such tablets achieve similar profiles of AUC, and... 

Current Good Manufacturing Practice for Finished Pharmaceuticals," Code of Federal Regulations, Tide 21, Part 211.25, U.S. FDA, Washington, D.C., 1988. 

Current Good Manufacturing Practice for Finished Pharmaceuticals, Sampling and Testing of In-Process Materials and Drug Products, (1998), CFR, Title 21, Part 211, Volume 4, Section 211.110. 

Current Good Manufacturing Practices for Finished Pharmaceuticals, U.S. Food and Drug Administration, 21 CFR 210 and 211... 

Part 211, current Good Manufacturing Practice for Finished Pharmaceuticals. 

PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS... 

Current Good Manufacturing Practices [135] establish the requirements for maintaining a stability program and require that most pharmaceutical dosage forms have an established expiration date supported by test data [134]. There are few allowable exceptions. 

Code of Federal Regulations, Title 21, Food and Drugs, Part 211, Current good manufacturing practice for finished pharmaceuticals, Subpart G, 211.137 Expiration Dating. 

The current Good Manufacturing Practice (cGMP) regulations are guidelines that FDA requires a pharmaceutical manufacturer to meet. Compliance with the cGMPs is a prerequisite for the approval of NDAs, INDs, and antibiotic forms. General areas in which... 

---