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The News in Depth

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 »

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 »

Not Keeping Current with Changing FDA Requirements and Slow Responses are Causing ANDA Approval Delays

Abbreviated New Drug Applications (ANDAs) are improving overall in content and submission format, but errors made due to not keeping up with changing requirements and applicants taking too long to respond to filing deficiencies found by reviewers are delaying some approvals, FDA’s Office of Generic Drugs (OGD) is reporting....
January 7, 2012 | Posted in CMC Review Policy, Generic, Generic/Biosimilar, Region/International, Specific Product Type, The News in Depth, US/Canada | Read More »

ICH “Points to Consider” Part Two on Implementing Q8-10 Addresses Models, Design Space and Process Validation

ICH has released the second half of its “Points to Consider” (PTC) on implementing Q8-10 with advice on: ● the use of models ● development of design space as part of the control strategy, and ● the use of process validation and continuous verification strategies....
January 4, 2012 | Posted in CMC Standards, ICH Q8-10/QbD, International, International Harmonization, QbD, Region/International, The News in Depth | Read More »

FDA and EMA Formalize Mutual Inspection Reliance Program

FDA and EMA have formalized a program for relying upon each others' facility inspection data beginning in January in an effort to better utilize agency resources and avoid duplicate work following two successful joint inspection pilots...
January 4, 2012 | Posted in Authorities, Europe, GMP Policy, Inspections/Info Sharing, International Harmonization, Region/International, The News in Depth, US/Canada | Read More »

Generic Drug Manufacturing Issues Draw FDA Warning Letters at Sandoz and Mylan

Oral solid manufacturing drew FDA warning letters in the fourth quarter of 2011 at two of the largest generic companies – Sandoz and Mylan. Injectable production was also implicated in the warning letter received by Sandoz....
January 3, 2012 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, Generic, Region/International, Specific Product Type, The News in Depth, US/Canada | Read More »
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