2010 July | IPQ Newsletter

Complaint and Deviation Handling, Contamination Control Continue to Draw FDA Attention at Vaccine Plants

Complaint and deviation handling/reporting and contamination control – concerns that have been in the forefront of FDA attention during vaccine manufacturing inspections – were again focal points at a March/April inspection of Sanofi Pasteur’s vaccine plant in Marcy l’Etoile, France that resulted in an “untitled letter” from the agency on July 22....

July 31, 2010 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, The News in Depth, US/Canada, Vaccines/Biologicals | Read More »

Understanding Biosimilar/Biobetter Approval Pathways and Differences Key to Success, Merck Exec Says

Success for both biotech innovator companies and biosimilar manufacturers under the new health care legislation will require working with FDA to optimize the regulatory approval pathways and understanding the key differences between biosimilars and biobetters, a Merck executive maintained in a recent interview....

July 30, 2010 | Posted in Biosimilar, CMC Review Policy, Generic/Biosimilar, The News in Depth, US/Canada | Read More »

Potential GMP Trouble Spots at India’s API Firms Include Equipment Handling, CAPA, Documentation, and Training, India Auditing Expert Finds

Potential GMP concerns among India’s expanding number of API suppliers include equipment handling, CAPA, documentation and training, Semler Research Center COO/Director Gurudatta Gayatri reported at the DIA Annual Meeting in June....

July 26, 2010 | Posted in Asia, GMP Deviations/Warning Letters, GMP Enforcement Activity, The News in Depth | Read More »

J&J Tallies Up the Impact of its Compliance and Recall Problems in Quarterly Investor Update

During a July 20 J&J investor’s conference call covering the company’s second quarter results, Investor Relations VP Louise Mehrotra provided an update on J&J/McNeil’s current compliance situation and the significant financial and operational impact of the firm’s compliance and recall problems (IPQ “In the News” May 6, 2010)....

July 22, 2010 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, The News in Depth, US/Canada | Read More »

FDA Concern with McNeil’s Complaint Handling Extends to Lancaster, PA Facility

McNeil’s complaint handling – a problem area cited in FDA’s January warning letter to parent company J&J regarding their Las Piedras, Puerto Rico plant and in an April inspection at the OTC drug manufacturer’s Fort Washington facility (IPQ “In the News,” May 6, 2010) – was also of concern to agency investigators in an inspection completed July 9 at McNeil’s plant in Lancaster, PA.

July 22, 2010 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, The News in Depth, US/Canada | Read More »

Legislation Introduced to Provide FDA Mandatory Recall Authority for Human and Animal Drugs

Chairman Edolphus Towns (D-NY) announced that he has introduced H.R. 5740, “a bill to provide for the mandatory recall of adulterated or misbranded drugs,” that would amend the Federal Food, Drug and Cosmetic Act (FD&C Act), to provide new recall authority to FDA....

July 20, 2010 | Posted in GMP Enforcement Activity, Recalls, The News in Depth, US/Canada | Read More »

International Joint API Inspection Pilot Program Sees Positive Results

The international API pilot joint inspection program involving regulatory authorities in the EU, US, and Australia is resulting in rapid sharing of inspection reports for non-compliant sites, follow-up inspections at other facilities owned by the companies found to have non-compliant sites, and prompt notification of regulatory actions taken....

July 19, 2010 | Posted in API, Inspections/Info Sharing, International Harmonization, The News in Depth | Read More »

Facility Listing Errors and Missing Development Data Draw Withhold Recommendations From FDA’s NJ District

Facility listing errors on the application and a lack of availability of development data source documents during pre-approval inspections are causing the New Jersey District to recommend withholding drug approvals, its investigations branch director Myriam Sosa told DIA’s June Annual Meeting....

July 16, 2010 | Posted in Inspection Initiatives, Preapproval, The News in Depth, US/Canada | Read More »

Communication Between CMC and Clinical Groups is Key in IND Phase, FDA says

FDA Center for Drug Evaluation and Research (CDER) is stressing that communication problems between the CMC and clinical groups working in Phase I can result in important risks not being identified and can impede IND/Phase I progress....

July 15, 2010 | Posted in CMC Review Policy, Investigational/Clinical, The News in Depth, US/Canada | Read More »

Preparing for and Communicating Manufacturing Changes During Late Stage Development Smoothes Biotech Clearance Process with FDA

Comparability studies for changes which inevitably occur during Phases II and III for biotech products must be planned for by the firms conducting them, FDA is stressing. The agency is also cautioning that communication with FDA during the end-of-Phase-II and pre-Biologic License Application (BLA) meetings and through the submission and preapproval inspection process.is important to understand common expectations and make it easier to work through issues that will arise due to these changes....