IPQ’s Monthly Update for May is Now Available
In the forefront of the IPQ coverage for May are important initiatives going on in Europe to improve and harmonize its regulation of medicinal quality and the supply chain on which that quality depends....
June 28, 2011 | Posted in The News in Depth | Read More »
Part 11 “Add-on” Coverage to FDA Surveillance Inspections Shedding Light on Industry Gaps
FDA is getting a better handle on where industry is having problems applying Part 11 as the results from its “add-on” coverage of computer systems during routine surveillance inspections begin to emerge....
June 24, 2011 | Posted in Inspection Initiatives, Part 11, The News in Depth, US/Canada | Read More »
OOS Result Handling Continues as Dominant Theme in FDA Warning Letters Issued Abroad
Giving adequate attention to out-of-specification (OOS) results in batch release decision making and investigation follow up continues as the dominant theme in 2011 in GMP warning letters issued to foreign companies by FDA’s drug and biologic compliance offices....
June 17, 2011 | Posted in API, Biotech Therapeutics, Europe, GMP Deviations/Warning Letters, GMP Enforcement Activity, Latin/South America, Middle East, Oral, The News in Depth, US/Canada | Read More »
Warning Letter to API Contract Testing Lab Cites Data Misrepresentation to Customers
A recent FDA warning letter to US-based API contract testing lab Toxin Technologies highlights the agency’s ongoing concern with the communication between contractors and their customers....
June 16, 2011 | Posted in API, GMP Deviations/Warning Letters, GMP Enforcement Activity, The News in Depth, US/Canada | Read More »
New CDER Compliance Super Office Structure Reflects Emerging Global Supply Chain Threats
FDA’s Center for Drug Evaluation and Research (CDER) is elevating and restructuring its Office of Compliance (OC) to better reflect the regulatory challenges posed by an increasingly complex global supply chain and the recent growth of the office’s staff and responsibilities....
June 15, 2011 | Posted in GMP Enforcement Activity, General, The News in Depth, US/Canada | Read More »
Lab Data Integrity at Issue in FDA Warning Letters Sent to China and India
Evidence of unreliable laboratory data has prompted the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER) to issue warning letters over the past few months to drug manufacturers in China and India....
June 13, 2011 | Posted in API, Asia, GMP Deviations/Warning Letters, GMP Enforcement Activity, Generic, Injectable, The News in Depth | Read More »
IPQ April 2011 Monthly Update Download for Jerry’s Linkedin Colleagues and Facebook Friends
I am pleased to provide my Linkedin colleagues with a complimentary download of our April 2011 Monthly Update, covering the important CMC and GMP developments during the Month of April. This will allow those of you who do not have a subscription or company license to see the value of our coverage. As a subscriber or company license holder, you would receive this level of in-depth analysis on all of our stories....
June 7, 2011 | Posted in Uncategorized | Read More »
