The New Excipient GMP Standard: A Guide for Drugmakers

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The New Excipient GMP Standard
A Guide for Drugmakers

The final NSF/IPEC/ANSI 363-2014 excipient GMP standard is the first American national standard for good manufacturing practices of pharmaceutical excipients … and was created with significant FDA input.

It is absolutely critical to every drug manufacturer's operation, helping you ensure that your quality controls will keep your product from being at risk — no matter where you are in the supply chain.

In this new report from FDAnews, NSF International Executive Director and QA/QC expert James Morris takes drugmakers on a detailed introductory tour of the 363 standard, beginning with how it aligns with (and differs) from the IPEC-PQG guide of 2006 and continuing through many of the new standard's key requirements, such as:

  • How the 363 standard affects risk assessments, management responsibility and data integrity for excipient makers

  • 9 major requirements for certifying a new batch of excipient

  • Documentation that sponsors should expect from suppliers when they change sub-suppliers

  • 6 key areas to check when auditing suppliers to assure they are complying with the standard

  • Top 3 considerations for excipient makers

    1. Defining the steps in the process to which GMPs apply
    2. Understanding your process and its critical control points
    3. Assessing points of highest risk of cross-contamination
  • Top 3 considerations for drugmakers

    1. Determining whether the excipient maker has completed an assessment against the standard
    2. Determining whether there were gaps identified in the assessment — and the excipient maker’s proposed time frame for closure of those gaps
    3. Determining whether the excipient maker’s management team has committed to the management responsibilities described in the standard
  • And much more

For your easy reference, the report also includes the full text of the new 363 standard.

Let FDAnews and NSF Executive Director James Morris be your guides to the new standard, the first of its kind in the U.S. Order The New Excipient GMP Standard: A Guide for Drugmakers today — it's a must-have, must-read report.

 

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Table of Contents

  • Introduction
  • Management Responsibility
  • Risk Assessments
  • Data Integrity
  • And More …

View the entire TOC

Who Will Benefit

  • Compliance officers
  • Manufacturing directors and supervisors
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel

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