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Guidance on Formal Dispute Resolution for CGMPs

In early August, FDA issued a comment request on its “Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.” The guidance is intended to provide information to manufacturers of human and veterinary drugs on how to initiate and resolve CGMP disputes (see IPQ October 30, 2013). […]

The Most-Read IPQ Stories of 2013

As a retrospective on the past year, IPQ is providing a compilation of the four stories that generated the largest readership. [Available in full to non-subscribers as well as subscribers.] The attention the stories drew is not surprising as they delve into four key current focal points in the CMC/GMP regulatory arena: ● data integrity ● contract relationships ● quality metrics, and ● process validation.

CDER Compliance Office Quality Regulatory Priorities for 2014 Include Implementing DQSA, FDASIA and Reorganization Plans

The top priorities at FDA’s Center for Drug Evaluation and Research (CDER) compliance office in 2014 will include implementing the compounding (Title I) and track and trace (Title II) provisions of the Drug Quality and Security Act (DQSA), signed into law in late 2013, along with the ongoing implementation efforts on the generic drug user fee (Title I), supply chain (Title VII) and drug shortage (Title X) facets of the 2012 FDA Safety and Innovation Act (FDASIA)....

FDA Moves Quickly to Implement Compounding Provisions of Drug Quality and Security Act

FDA is moving quickly to give regulatory flesh to the compounding provisions of the new Drug Quality and Security Act of 2013 (DQSA), signed into law by President Obama on November 27....

Level of Industry Response to FDA’s Quality Agreement Draft Guidance Reflects Contracting Challenges; Terminology at Issue

The raft of industry comments FDA has received on its draft guidance on “Quality Agreements for Contract Manufacturing Arrangements for Drugs” underscores the importance of having clear terminology when addressing the complexities in the contracting arena....

Successful Tech Transfer to a CMO Depends on a Strong Quality Agreement and Open Communication Pathways, FDA Asserts

A detailed description of how a drug product owner will transfer technical knowledge to a contract manufacturer needs to be part of a quality agreement, FDA officials are stressing....

Joint Drafting of Contract Manufacturing Quality Agreements Needed to Reflect Shared Quality Ownership, FDA Stresses

FDA is stressing that quality agreements between product owners and the contract manufacturing organizations (CMOs) they work with should be drafted jointly by both parties and reflect the depth of understanding each has regarding their roles and responsibilities in the intimate relationship they share....

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....

FDA Draft Guidance on Quality Agreements for Drug Contract Manufacturing Nears Release

An FDA cross-center working group has developed a draft guidance on quality agreements for drug contract manufacturing that is undergoing the final stages of FDA internal review and is expected to be released for public comment this summer....

QP Review of More Complex Supply Chains and Applications, EU Member State Differences, Among Issues Facing EMA in Annex 16 Revision

EMA’s GMP/GDP Inspectors Working Group (IWG) is wrestling with how to build into EU GMP Annex 16 the assurance that the Qualified Person (QP) understands the complexities of a globalized supply chain in certifying that a batch complies with GMP/GDP requirements and the new mandates of the Falsified Medicines Directive (FMD)....
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