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› Best Practices
FDA Current Good Manufacturing Practices (cGMPs) for Finished Pharmaceuticals
- By: Staff Editor
- Date: February 27, 2015
Current Good Manufacturing Practices are regulations published by FDA to provide criteria for complying with the Federal Food, Drug, and Cosmetic Act (FD&C Act). cGMP requires all drug products that are developed and produced are safe, properly identified, of the correct quality, strength, and purity. The word “current” is used in conjunction with GMP as technologies are constantly evolving and so do the requirements to attain GMP compliance. Even though cGMP regulations have been in place since long time, the large number of 483's and warning letters demonstrate that companies have problems with implementation. The GMP regulations are codified in 21 CFR 210-211.
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Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
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By - Christopher W. Olmsted
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How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
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By - Madhavi Diwanji
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