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Archive for ‘October, 2011’

Airport Radiation Screening-Induced Recall Highlights PET Drug GMP Challenges; FDA Releases PET Media Fill Guidance

The challenge and importance of GMP management of positron emission tomography (PET) drug processes is underscored by FDA in a new guidance released in October on PET media fills and exemplified by a recent recall of a prominent PET generator...
October 31, 2011 | Posted in GMP Enforcement Activity, GMP Policy, PET, Product Type Specific, Recalls, Region/International, Specific Product Type, The News in Depth, US/Canada | Read More »

Significance of 483 Observations Depends on Product Impact, FDA Compliance Officials Explain

FDA compliance officials are stressing that their judgment of the significance of an investigator's 483 observation is case-specific, reflecting its implications for the quality of product(s) and the firm’s transparency with the agency about that potential impact....
October 31, 2011 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, Region/International, The News in Depth, US/Canada | Read More »

Suppliers See Cost/Quality Disconnect in Big Pharma Decision Making

Suppliers are experiencing a significant disconnect between big pharma’s avowed quality-by-design-based supply chain objectives and the actual purchasing decisions it is making based only on price....
October 30, 2011 | Posted in Excipient, General, Region/International, Specific Product Type, Supply Chain/GDPs, The News in Depth, US/Canada | Read More »

Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections

Incomplete or inaccurate facility information on NDA/ANDA form 356h cover letters are causing decisions on conducting preapproval inspections (PAIs) to be delayed or tabled, FDA field managers are reporting.
October 29, 2011 | Posted in Authorities, GMP Policy, Inspection Initiatives, Preapproval, Region/International, The News in Depth, US/Canada | Read More »

MHRA Consults on Regulation Consolidation

MHRA is seeking input on its draft consolidated regulations and proposals for policy changes as part of its initiative to streamline and harmonize its existing regulatory framework.  Comments are due by January 17, 2011. According to the agency press release, “the current body of UK medicines legislation comprises the Medicines Act 1968 and approximately 200 statutory [...]
October 29, 2011 | Posted in Authorities, CMC Review Policy, CMC Standards, Europe, GMP Policy, News Brief, Region/International | Read More »

Baxter Issues Recall of Flu Vaccine in the UK

In late October, Baxter issued an immediate action (MHRA Class 1) recall in the UK for two batches of its Preflucel flu vaccine.  According to the MHRA recall alert, “No further Prefucel of any batch should be administered at this time.” The UK Daily Mail reports that the recall covers about 300,000 doses distributed in early [...]
October 28, 2011 | Posted in Europe, GMP Enforcement Activity, News Brief, Recalls, Region/International, Specific Product Type, Vaccines/Biologicals | Read More »

FDA Releases FY2010 Inspection Summary and Observations

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October 25, 2011 | Posted in GMP Enforcement Activity, General, News Brief, Region/International, US/Canada | Read More »

Australia’s TGA Proposes Adoption of Several EU/ICH Guidelines

Australia’s Therapeutic Goods Administration (TGA) is requesting comment on its proposed adoption of several EU and ICH guidelines, and “non-adoption” of one.  The comment period closes on November 9. The following guidelines are proposed for adoption: ● ICH Topic Q3C (R4) Impurities: Guideline for Residual Solvents ● ICH Guideline Q4B Annex 12 to Note for Evaluation and Recommendation [...]
October 22, 2011 | Posted in Australia, Authorities, CMC Standards, GMP Policy, General/Quality, International Harmonization, News Brief, Other ICH, Region/International | Read More »

Baxter Resolves FDA Warning Letter For Puerto Rico Sites, CEO Reports

Baxter has closed out an FDA warning letter issued in January for problems the agency found at two of its Puerto Rico plants, the firm’s CEO Robert Parkinson said in a third-quarter earnings call in late October. FDA findings during a mid-2010 inspection at Baxter’s facility in Jayuya, Puerto Rico that appropriate action had not been [...]
October 22, 2011 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, News Brief, Recalls, Region/International, US/Canada | Read More »

Brazil’s ANVISA Establishes Biological Medicines Office

This news brief is provided as a service to IPQ subscribers. Subscribers click here. For subscription/license information, click here.
October 22, 2011 | Posted in Biosimilar, Biotech, Biotech Therapeutics, CMC Review Policy, CMC Standards, Generic/Biosimilar, Latin/South America, News Brief, Region/International, Specific Product Type | Read More »
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