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Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline

Implementation of the ANSI NSF-IPEC 363 standard on GMPs for excipients by pharma and excipient manufacturers will help ensure that they are compliant with the supply chain mandates of the FDA Safety and Innovation Act (FDASIA), the EU Falsified Medicines Directive (FMD), and the newly-completed EU excipient risk assessment guideline....

Sponsor/CMO Communication Gaps Will Have Negative Inspection Fallout, FDA Field Investigator Cautions

The lack of communication between sponsors and contract manufacturing organizations (CMOs) – particularly those located abroad – can make the FDA inspection process a difficult one and can jeopardize the compliance position of the CMO involved as well as the approval of the sponsor’s application, agency investigators are warning....

Growing Cooperation Between FDA and EMA Highlighted in Recent Ben Venue Inspections

The mutual focus of FDA and EMA on aseptic processing compliance at Ben Venue’s Bedford, Ohio plant – which has resulted in an EMA recommendation to recall three oncology drugs contract-manufactured by Ben Venue and the firm's decision to cease operations at the facility while the issues raised are being addressed – illustrates the increasing level of cooperation among international agencies in the GMP arena....

Product Quality Responsibilities Shared Between CMOs and Sponsor Firms Under FDA Scrutiny

FDA is putting industry on notice that relationships between sponsors and contract manufacturing organizations (CMOs) will be receiving close attention during upcoming agency inspections....

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CLICK HERE  for the IPQ Monthly Update – May 2021 in Review


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