FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.
Amy Ritter
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Amy Ritter is Scientific Editor, BioPharm International and Pharmaceutical Technology. Amy Ritter joined the editorial staff of BioPharm International and Pharmaceutical Technology in 2011. She received her BA in Biology from Boston University, and holds a PhD in Neurobiology from SUNY at Stony Brook. Before joining Advanstar’s Pharm Sciences group, she worked in the preclinical pharmacology group at Merck Research Labs, and is the author of numerous peer-reviewed scientific publications.
Articles by Amy Ritter
The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.
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Latest Updated Articles
- FDA Adopts Final Version of Q11 Guidance
Published: November 20th 2012 | Updated:
- USP Announces Proposed Standard for Supply-Chain Integrity
Published: January 12th 2012 | Updated:
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