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The News in Depth

ICH Q4B Annex 13 on Powder Density and Annex 14 on Bacterial Endotoxin Testing Out for Comment

FDA has made available for comment the Step 2 drafts of ICH Q4B Annex 13 covering the bulk density and tapped density of powders and Annex 14 on bacterial endotoxin testing. The drafts were cleared for release by the ICH Steering Committee meeting in June....

WHO Proposes New Guideline for Microbiology Labs and Adjustments to Site Master File, Water and HVAC Guides

WHO is expanding its guidance library to focus specifically on GMP expectations for microbiology labs and is adjusting its existing guidelines on drafting site master files, on water used in pharmaceutical manufacturing and on heating, ventilation, and air-conditioning (HVAC) systems....

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....

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....

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....

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)....

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.

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....

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....

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....
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