GMPs/Validation News - BioPharm International

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GMPs/Validation News
News about regulatory compliance, good manufacturing practices (GMPs), and validation, emerging regulatory policies, and developments in biosimilars.

FDA Issues Warning Letter to GSK Biologicals

June 26, 2014

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA Issues Warning Letter to API Manufacturer Apotex Pharmachem India

June 18, 2014

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

FDA Issues Warning Letter to Tianjin Zhongan Pharmaceutical

June 18, 2014

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

ISPE Announces Quality Metrics Pilot Launch

June 17, 2014

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.

FDA Outlines Agenda for New Guidances in 2014

February 5, 2014

FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market

January 24, 2014

FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location

Genzyme Receives Complete Response Letter from FDA on Lemtrada Application

December 31, 2013

Genzyme plans to appeal FDA?s decision that the multiple-sclerosis treatment is not ready for approval.

Baxter Initiates Worldwide Voluntary Recall

December 30, 2013

Baxter International recalls dextrose injection and four sodium chloride injections.

FDA Approves Extended-Release, Single-Entity Hydrocodone Product

October 28, 2013

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

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