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Archive for ‘December, 2010’

PIC/S Site Master File Guide Updated on Quality Management System Expectations

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has adopted a rewrite of its site master file (SMF) guide for industry that upgrades the expectations on quality management systems (QMS) – and the quality risk management (QRM) and supply chain components in particular – to keep pace with ICH Q9 and Q10....
December 29, 2010 | Posted in International, International Harmonization, PIC/S, The News in Depth | Read More »

Membership & US Entry, GDPs, QRM Guidance and Traditional/Herbal Medicine Inspections Draw PIC/S Attention

FDA’s entry into the Pharmaceutical Inspection Cooperation Scheme (PIC/S) at the beginning of 2011 will be marked by the participation of Commissioner Margaret Hamburg at PIC/S’ upcoming 40th anniversary symposium on “Challenges and Future Perspectives” in Geneva, Switzerland in late May....
December 29, 2010 | Posted in General, International, International Harmonization, PIC/S, Supply Chain/GDPs, The News in Depth | Read More »

IPQ’s Monthly Update for November 2010 Now Available

Among the important regulatory developments in the U.S. in November was a hearing held by FDA to obtain input on specific issues and challenges associated with the implementation of the new biosimilars legislation. IPQ’s coverage encompasses a proposal from Amgen at the hearing on a two-tier process in which interchangeability decisions would trail biosimilar approvals....
December 23, 2010 | Posted in The News in Depth | Read More »

IPQ Monthly Update — November 2010

Now available, IPQ's Monthly Update covering the important CMC/GMP stories that happened during the Month of November.
December 23, 2010 | Posted in Issue Archive, Monthly Update | Read More »

ASEAN Effort Progressing on CMC/GMP Harmonization, But Differences Remain

An analysis of the CMC/GMP regulatory framework among the Association of South East Asian Nations (ASEAN) shows significant progress in moving toward a more cohesive and harmonized approach, although differences remain in individual country requirements and procedures....
December 20, 2010 | Posted in Asia, International Harmonization, Other Organizations, Purity/Potency/Identity/Stability, The News in Depth | Read More »

More Guidance on Transport Storage Conditions Targeted by EMA

The European Medicines Agency (EMA) is proposing to expand its guidance on transport storage conditions to better address the challenges of an increasingly complex ingredient supply and product distribution chain....
December 12, 2010 | Posted in Component Supply, Europe, Shipping & Storage, Supply Chain/GDPs, The News in Depth | Read More »

Analytical Method Transfer In Focus in EU Effort to Revise GMP Chapter 6 on Quality Control

The transfer of analytical laboratory methods within and between companies is being targeted by the European Medicines Agency (EMA) to receive more attention in a revision to its EU GMP Guide Chapter 6 on quality control....
December 11, 2010 | Posted in Europe, GMP Policy, Laboratory, The News in Depth | Read More »

McNeil’s Compliance Problems Continue With New FDA Inspection Findings and a Recall

Compliance problems continued to plague J&J’s OTC drug subsidiary McNeil in November with the firm announcing the recall of another bolus of children’s medicines made at its Fort Washington plant and the receipt of a substantial 483 from FDA investigators at the conclusion of a lengthy inspection of its Las Piedras, Puerto Rico facility....
December 7, 2010 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, OTC, Recalls, The News in Depth, US/Canada | Read More »

Active Ingredient and Starting Material Supply Chains in Focus in Draft Revision to EU GMP Guide Chapter 5

The European Commission (EC) has released for comment a revision to EU GMP Guide Chapter 5 on production that provides new requirements for control of active ingredient and starting material supply chains, including reports documenting periodic supplier audits for inspector review....
December 1, 2010 | Posted in Component Supply, Europe, GDP/Supply Chain, GMP Policy, Supply Chain/GDPs, The News in Depth | Read More »

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