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The European Commission will revise four chapters of its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said June 1, adding that the current system of different expectations is not sustainable. Read More
Health Canada has launched an online public database of information relating to drug company inspections, including which firms have a good history of meeting safety and quality standards and which do not. Read More
The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More
The FDA handed Gilead Sciences an eight-observation Form 483 for an array of production issues, including poor manufacturing instructions and processing procedures. Read More
A slew of observations related to control records, data integrity and manufacturing at Dr. Reddy’s Andhra Pradesh, India, facility resulted in a Form 483. Read More
The FDA increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds. Read More