2012 January | IPQ Newsletter

Ranbaxy Consent Decree Fires FDA Warning Shot for Ex-US Pharma on Data Integrity

The consent decree signed between Indian generic drug manufacturer Ranbaxy and the US Department of Justice (DoJ) serves as a warning shot across the bow for companies supplying to the US market that FDA findings of falsified information in applications or CGMP records will have very substantial consequences....

January 30, 2012 | Posted in Asia, Consent Decrees, GMP Enforcement Activity, Region/International, The News in Depth | Read More »

USP and IPEC-Europe Weigh in on GDPs for Excipients

USP and the European branch of the International Pharmaceutical Excipients Council (IPEC-Europe) have both released guidance for pharmaceutical companies on the evaluation and handling of excipient distribution....

January 19, 2012 | Posted in CMC Standards, Compendial, Europe, Excipient, General, International Harmonization, Pharmacopeias, Region/International, Specific Product Type, Supply Chain/GDPs, The News in Depth, US/Canada | Read More »

IPQ’s Monthly Update for January is Now Available

Generic drug regulation has been very much in the IPQ spotlight recently on both the CMC review and GMP compliance fronts, with generic drug user fees nearing implementation, biosimilars on the horizon, and compliance problems surfacing at some of the big generics manufacturing operations....

January 18, 2012 | Posted in The News in Depth | Read More »

IPQ Monthly Update — January 2012

The Monthly Update covering key recent CMC and GMP developments in the US, Europe and internationally is now available.......

January 17, 2012 | Posted in Current Issue, Issue Archive, Monthly Update | Read More »

PET Drug Generator Recall Investigation Points to Hospital User Error

In mid-January, FDA updated healthcare professionals and the public regarding preliminary findings from ongoing investigations following the recall of CardioGen-82 in late July by the manufacturer, Bracco Diagnostics. The findings point to improper use of the equipment as responsible for some patients receiving excessive radiation exposure. FDA “believes it is unlikely that this excessive exposure posed [...]

January 16, 2012 | Posted in GMP Enforcement Activity, News Brief, PET, Recalls, Region/International, Specific Product Type, US/Canada | Read More »

FDA Transmits Prescription, Generic and Biosimilar Drug User Fee Proposals to Congress

On Friday, January 13, Health and Human Services Secretary Kathleen Sebelius transmitted FDA’s recommendations to Congress for the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA) and for new user fee programs for generic drugs and biosimilar products. Under a user fee program, industry agrees to pay fees to help fund a portion [...]

January 16, 2012 | Posted in Biosimilar, CMC Review Policy, Generic, Generic/Biosimilar, News Brief, Region/International, Specific Product Type, US/Canada | Read More »

EMA Biosimilar Concept Paper Released for Comment

The European Medicines Agency (EMA) has released for comment a concept paper on the proposed revision of its “overarching” 2005 “similar biological” guideline to clarify concepts and provide updates that reflect how biosimilars are currently being developed by applicants. Comments are due by the end of February. EMA notes in the introduction to the draft that [...]

January 15, 2012 | Posted in Biosimilar, CMC Review Policy, Europe, Generic/Biosimilar, News Brief, Region/International, Specific Product Type | Read More »

FDA Generic Drugs Office Advances QbD, Review Processes and Quality Management System in Anticipation of User Fees

FDA’s Office of Generic Drugs (OGD) is making significant strides forward in its efforts to implement quality by design (QbD), refine its review processes and implement a quality management system, in anticipation of the resource underpinning that user fees will provide....

January 14, 2012 | Posted in CMC Review Policy, Generic, Generic/Biosimilar, Region/International, Specific Product Type, The News in Depth, US/Canada | Read More »

Consumer Complaints, FDA Inspection at Novartis Nebraska Plant Leads to Recalls and Temporary Manufacturing Shutdown

Consumer complaints of bottles containing mixed-up or damaged tablets and capsules and an extended FDA 483 focused on complaint handling at a Lincoln, Nebraska facility where they were made prompted Novartis to recall a handful of its over-the-counter (OTC) products and temporarily cease operations at the plant....

January 14, 2012 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, OTC, Recalls, Region/International, Specific Product Type, The News in Depth, US/Canada | Read More »

Key Pillars of a Quality Culture are Management Commitment, Sharing Inspection Results and Early QbD, Industry Execs Affirm

Key pillars for global pharmaceutical companies in building effective quality cultures within their organizations and extending them to their contract partners are commitment and communication by senior management, openly sharing inspection information across sites, and a quality-by-design approach beginning in early development, industry executives maintain....

January 12, 2012 | Posted in Generic, ICH Q8-10/QbD, International, International Harmonization, Region/International, Specific Product Type, The News in Depth | Read More »

Archive for ‘January, 2012’