IPEC e-newsletter - Excipients Insight March 2017 - 31-03-17


Inside this issue


EXCiPACT excipients certification standards revision public consultation opens

The EXCiPACT asbl Board is pleased to announce the draft 2017 revision of the GMP and GDP standards used in their independent, 3rd party international certification scheme for manufacturers, suppliers and distributors of pharmaceutical excipients. The document is now open for comment and EXCiPACT invites interested parties to participate in the public consultation.

In 2016, the EXCiPACT asbl Board commissioned a project team to prepare a draft revision of the
EXCiPACT standards to undertake an alignment to ISO 9001:2015 and ISO/IEC 17021-1:2015 without
change or enhancement of any individual requirements, other than to correct errors in the January 2012 publication.

The draft 2017 Standards Revision document completed by the project team and a mandatory Review Template for the submission of comments are both downloadable from the home page of the EXCiPACT website: www.excipact.org.

The deadline for comment is Friday 5 May 2017. It is important to note that only those comments received by this date on a correctly completed Review Template with proposed alternative wording will be considered. Any other form of comments, or failure to propose alternative wording, or any anonymous comments, will be disregarded.

The target date for publication of the new 2017 EXCiPACT Revised Standards is third quarter 2017.




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