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
Defining the steps in the process to which GMPs apply
Understanding your process and its critical control points
Assessing points of highest risk of cross-contamination
Top 3 considerations for drugmakers
Determining whether the excipient maker has completed an assessment against the standard
Determining whether there were gaps identified in the assessment — and the excipient maker’s proposed time frame for closure of those gaps
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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