Feb 3, 2011
By:
Angie Drakulich
The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.
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A roundtable moderated by Angie Drakulich.
Feb 2, 2011
By:
Angie Drakulich
A roundtable moderated by Angie Drakulich.
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Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.
Feb 2, 2011
By:
Angie Drakulich
Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.
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USP helps to improve drug quality in 32 countries.
Feb 2, 2011
By:
Angie Drakulich
USP helps to improve drug quality in 32 countries.
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A contract-service provider roundtable, featuring Albemarle, Baxter, DPT, Pfizer CentreSource, Dr. Reddy's, SAFC, and Vetter. Read this and other preferred organization articles in this special issue.
Feb 1, 2011
By:
Angie Drakulich
A contract-service provider roundtable, featuring Albemarle, Baxter, DPT, Pfizer CentreSource, Dr. Reddy's, SAFC, and Vetter. Read this and other preferred organization articles in this special issue.
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Jan 20, 2011
By:
Angie Drakulich
FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.
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Jan 13, 2011
By:
Angie Drakulich
As part of its transparency initiative, which began in June 2009, FDA launched a website during the first week of January 2011 that addresses basic questions for industry about regulated products.
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Jan 2, 2011
By:
Angie Drakulich
Industry executives share insight into the future direction of drug manufacturing and the supply chain.
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Industry experts offer their best practices for dealing with deviations. This article contains online bonus material.
Jan 2, 2011
By:
Angie Drakulich
Industry experts offer their best practices for dealing with deviations. This article contains online bonus material.
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