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EDQM CEP Form Updates

The application forms for requesting certificates of suitability (CEPs) were updated in late September to reflect recent changes to the EDQM guideline on the requirements for revision/renewal of CEPs to the European Pharmacopeia Monograph, issued in July 2014, as well as invoicing changes. These forms are meant to be used for applications submitted from October […]

Comments on EMA’s Variations Stability Testing Guideline

In mid-August, EMA released a complete list of the comments it had received, along with an explanation of how they were handled, on its draft “Guideline on stability testing for applications for variations to a marketing authorization” issued in June 2011. The final version was issued in March 2014 (IPQ “News In Brief” April 2, […]

IPQ Monthly Update, July 2014

IPQ’s coverage during July focused heavily on the efforts worldwide to address the threats that loom along the global supply chain to the quality of the products that patients receive. Included in the July Monthly Update are stories addressing: ● APEC’s broad-based, multi-faceted initiatives ● pharmacopeial modernization and harmonization efforts, and ● FDA’s track and trace implementation. Also in this issue are valuable insights from FDA’s microbiology review staff on: ● top micro deficiencies in applications, and ● upgrading micro methods and processes....

Guides on FDA’s Generic Drug Review Process Continue Apace in July; EU Pilot Pursues Generic Drug Review Streamlining Internationally

The efforts by the Office of Generic Drugs (OGD) to clarify and streamline the Abbreviated New Drug Application (ANDA) process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA) continued apace in mid-July with the release of draft guidances on post-approval supplements and easily correctable deficiencies. Comments on the drafts are due by mid-September....

EU GMP Chapters 3, 5, 8, Finalized

The EU Commission has published final versions of EU GMP chapters 3, 5, and 8, which will go into effect in March 2015. The drafts of the chapters were issued in early 2013. Chapter 3 on premises and equipment was revised to: ● emphasize the use of quality risk management (QRM) principles for cross-contamination when […]

Ph. Eur. Requests Comments on Inhaled Drug QC Methodologies

The Inhalanda Working Party of the European Pharmacopoeia issued an inquiry in August, seeking comments and/or data on Abbreviated Impactor Measurement(AIM) and Efficient Data Analysis (EDA) methodologies for the quality control of inhaled drugs. The working party is looking for information that shows whether AIM and/or EDA can be effectively used in the quality control […]

EDQM Revises CEP Requirements Guideline

EDQM has revised its “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs” to include the requirements of the revised EU guideline on “Stability testing for applications for variations to a marketing authorization” and to describe the type of change to be submitted when a Certificate of Suitability (CEP) for […]

Cocrystals Reflection Paper Open for Comment

A reflection paper on the use of cocrystals in drug products was opened for comment by EMA at the end of July. The paper clarifies EMA’s position on cocrystals as API’s by giving definitions and discussing the regulatory implications of using them.

Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants

The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes....

APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches

The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices....
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