FDAnews Announces — New Standards for Excipient GMPs: Analyzing the Impact of NSF/IPEC/ANSI 363-2014 Webinar, May 27, 2015

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The NSF International, the American National Standards Institute, and the International Pharmaceutical Excipients Council of the Americas have released the final version of NSF/IPEC/ANSI 363-2014, the first American National Standard for good manufacturing practices of pharmaceutical excipients. Currently voluntary, the FDA was deeply involved in its development, and IPEC-Americas, ANSI and NSF are petitioning the FDA to adopt it as official guidance or regulation.

New Standards for Excipient GMPs:
Analyzing the Impact of NSF/IPEC/ANSI 363-2014
**FDAnews Webinar**
May 27, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/NewGMPStandards

Most drugs contain 70-90% excipients, which serve as taste-maskers, glidants, anti-oxidants, flow aids, binding agents or other purposes that facilitate the manufacturing process and improve chemical stability. The globalization of the pharma industry, combined with a regulatory focus on preventing counterfeits and adulterated products has created a need for a comprehensive excipient quality and control standard.

Now NSF International, the American National Standards Institute, and the International Pharmaceutical Excipients Council of the Americas have released the final version of NSF/IPEC/ANSI 363-2014, the first American National Standard for good manufacturing practices of pharmaceutical excipients.

Currently voluntary, the FDA was deeply involved in its development, and IPEC-Americas, ANSI and NSF are petitioning the FDA to adopt it as official guidance or regulation.

The standard covers everything from cross-contamination to change control, recordkeeping and equipment maintenance. It advises conducting risk assessments in order to determine the need for risk mitigation strategies. Such an assessment by the quality unit should identify materials and services that could affect excipient quality and track that status from delivery to customers.

Excipient makers must also establish a process for tracing excipients to the finished drug maker.
Furthermore, they need to have a documented system for selecting, approving and reapproving their suppliers, as well as defining how they will assess changes and alert clients, and creating procedures to handle customer complaints.

No matter where a company is in the supply chain, the new excipient standard is crucial knowledge to make sure quality controls prevent products from being at risk.

In this one-of-a-kind 90-minute webinar, attendees will learn:

  • 9 requirements for certifying every batch of excipient passes cGMP requirements
  • What documentation sponsors should expect from suppliers when they change sub-suppliers
  • 6 key procedures for auditing suppliers to assure they are complying with NSF/IPEC/ANSI 363-2014
  • Best practices for working with suppliers to assure proper and timely reporting of customer complaints
  • What should to do if suppliers are not ready by the proposed Q3 deadline?
  • The latest on if/when the FDA might adopt this as official guidance

Meet the Presenter:
Maxine Fritz — Executive Vice President of Pharma Biotech Consulting at NSF Health Sciences
Maxine Fritz has 25-plus years of combined FDA, industry and consulting expertise and is responsible for overseeing the pharma biotech practice at NSF Health Sciences. Ms. Fritz works with clients in the pharmaceutical, biologics, biotech and medical device industries to develop quality assurance, manufacturing and regulatory strategies for compliance with FDA regulations. She conducts and oversees regulatory gap analyses, assists with the development and implementation of quality systems, and develops and implements corrective action plans.

Who Will Benefit:

  • Compliance Officers
  • Manufacturing Directors and Supervisors
  • Pharmaceutical and cGMP Auditors
  • QA/QC Personnel

Conference Details:
New Standards for Excipient GMPs:
Analyzing the Impact of NSF/IPEC/ANSI 363-2014
**FDAnews Webinar**
May 27, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/NewGMPStandards
Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/NewGMPStandards
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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