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ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

EU Excipient GMPs Guideline

The European Commission (EC) released a final risk assessment guideline on GMPs for excipients in late March. The guideline points to ICH Q9 for basic principles and goes on to emphasize the need for focus on impurities risks as well as excipient traceability.

Comment Extension on cGMPs for Combination Products

The comment period on FDA’s draft guidance on cGMPs for combination products has been extended until April 23. The draft was issued in January (IPQ “News in Brief” January 27, 2015). The Regulatory Affairs Professional Society (RAPS) in conjunction with FDA held a workshop to discuss the new draft guidance and collect industry feedback on […]

Draft CGMP Requirements for Combination Products

In late January, FDA released a draft guidance on CGMP requirements for combination products. The guidance is organized into four main sections, covering: ● background ● general considerations for CGMP compliance ● specific information on 21 CFR 4.4(b), and ● applications for specific types of combination products. The guidance fleshes out the January 2013 final rule 21 CFR […]

FDA’s Center for Veterinary Medicine Using QbR and Other CDER-Tested Approaches to Decrease Review Times; CVM User Fees Drive Guidance Development

The use by FDA’s Center for Veterinary Medicine (CVM) of a question-based review (QbR) approach in CMC submissions over the past three years has resulted in significantly decreased review times for both new and abbreviated new animal drug applications (NADAs and ANADAs) for multiple dosage forms, including sterile products – in many cases with the reviews accomplished in a single cycle....

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.

Comments on FDA’s Draft Compounding Guidances Reflect Complex Factors and Varied Stakeholders Involved

Draft guidances and Federal Register (FR) notices issued by FDA in December to help implement the compounding provisions in the Drug Quality and Safety Act (DQSA) drew a wide array of comments that reflect the complexity of the factors that need to be considered in advancing the regulatory processes for compounding....

The Sterility Risks in Pharmacy Compounding Can Be Limited, Not Eliminated, Experts Stress at USP Forum

The sterility control challenges that pharmacy compounding presents stretch from practitioners trying to handle continually changing procedures and preparations, to the laboratories trying to do quality control testing in the context of these shifting targets and sample constraints, to the array of distribution and storage avenues – and limiting the risks rather than eliminating them should be the goal, participants at a US Pharmacopeia (USP) forum agreed....

U.S. and Five Other Countries Await Listing Decision Under EU’s Falsified Medicines Directive

The U.S. is among six countries with applications pending at the European Commission (EC) to be listed as a third country with GMPs equivalent to those in force in the EU, which allows continued export of active pharmaceutical ingredients (APIs) into the EU without a company-specific certification under the terms of the EU’s Falsified Medicines […]

FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders

A review of the initial results from an inspection blitz of about 30 high-volume sterile pharmacy compounding operations nationwide launched by FDA in late February shows a clear pattern of weakness in their sterile practices including environmental monitoring, gowning, personnel practices and sterility/endotoxin testing....
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