Good Manufacturing Practice

(redirected from Current good manufacturing practice)
Also found in: Acronyms.

Good Man·u·fac·tur·ing Prac·tice

(gud man-yū-fak'shŭr-ing prak'tis)
Regulations related to the production, storage, and distribution of drugs and medical equipment.
References in periodicals archive ?
The FDA is seeking a permanent injunction against US Stem Cell Clinic LLC of Sunrise, Fla., its Chief Scientific Officer Kristin Comella, and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.
The FDA is seeking a permanent injunction against US Stem Cell Clinic LLC of Sunrise, Fla., its chief scientific officer Kristin Comella, and co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.
The FDA identified non-conformities with current good manufacturing practice.
Sun Pharma said in a statement that the Gujarat facility is a dedicated cephalosporin plant (API and formulations), and the import alert was a follow-up to observations from the previous inspection and due to non-compliance of cGMP (current good manufacturing practice) regulations.
Notices for "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food" and "Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption" were published in the Jan.
Steven Victor issued a statement announcing the company would be moving to a new facility next month which it believes will address the current good manufacturing practice issues referred to in the letter, MedCity News reported.
The system protects products while maintaining cGMP (current Good Manufacturing Practice) to meet FDA Requirements.
The unit will operate to cGMP (current good manufacturing practice) as is required by regulators and customers for active ingredients.
Avid began manufacturing commercial product for Halozyme under current good manufacturing practice (cGMP) during 2004.
Citroflex A-6, Citroflex B-6, and ATBC/PG have Drug Master Files and are manufactured under Current Good Manufacturing Practice (CGMP) guidelines.
The new plant, which is to comply with cGMP (current Good Manufacturing Practice), will go into operational in August 2007.
Among their topics are the approval process for new drugs before and after 1962, the generic drug approval process after the 1984 Hatch-Waxman reform, the influence of the Prescription Drug User Fee Act on the approval process, active pharmaceutical ingredients, current good manufacturing practice and the drug approval process, ways and means to registering foreign drugs in the US, and the impact of government regulations on marketing and advertising.

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