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Quality Digest

FDA Compliance

Audio Conference on FDA’s Revised Standards for Water CGMPs

Published: Tuesday, January 22, 2008 - 23:00

(FDANews: Falls Church, Virginia) --The Food and Drug Administration recently issued proposed changes to the drug-manufacturers’ clinical good manufacturing practices (CGMPs) (21 CFR 210/211). The revised standards would affect three major areas: water quality, verification by a second individual, and aseptic processing.

Water quality—The rules remove the defined EPA water standard and replace it with “water fit for human consumption.” But the standard of what is considered fit for human consumption can vary from one country to another. Do you know what it is for your outsourced suppliers? Could your product be tainted, yet CGMP-compliant?

Verification—The changes state that when operations are performed by automated equipment, only one person is needed to verify that the automated equipment is functioning accurately.

Aseptic processing—The new rule makes numerous updates to equipment cleaning and maintenance, testing and approval or rejection of components, drug product containers and closures, sampling and testing of in-process materials, and control of contamination.

In this 90-minute audio conference on Wednesday, January 30, 2008, 1:30 p.m.–3:00 p.m. EST, compliance expert Barbara Immel, president of Immel Resources LLC, a management consulting and publishing firm offering services in regulatory compliance, quality assurance, and training for the pharmaceutical, biotechnology, medical device and related industries, delves into these changes and updates attendees on the current state of CGMP compliance.

Topics covered will include:
•   Point-by-point analysis of the proposed GMP changes and new draft guidance
•   Recommendations for how a company can submit comments to affect the Direct Final Rule
•   Potential unintended consequences of the proposed Direct Final Rule as written
•   Analysis of the more than 70 GMP-related warning letters issued during the last 12 months
•   Where FDA investigators are focusing their attention regarding GMPs
•   Review of recent serious compliance cases and strategies for not making the same mistakes
•   10 dos and don’ts for creating and maintaining compliant GMP operations

For more information, visit www.fdanews.com/conference/detail?eventId=2081


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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.