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The EPIC Audit ProgrammeAnnex 2Agreement on Audit Execution between(Qualified Person (UP) of the Manufacturing Authorization Holder or responsible person of the API manufacturer, hereinafter referred
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How to fill out eu gmp annex 16

01
Familiarize yourself with the requirements outlined in EU GMP Annex 16.
02
Ensure that your facility meets all necessary standards and guidelines for GMP compliance.
03
Review your manufacturing processes and procedures to ensure they align with the requirements of Annex 16.
04
Complete all necessary documentation accurately and thoroughly.
05
Submit the completed Annex 16 to the appropriate regulatory authorities for approval.

Who needs eu gmp annex 16?

01
Companies involved in the manufacturing and distribution of medicinal products for human use in the European Union.
02
Organizations seeking to ensure compliance with GMP standards and regulations set forth by the EU.

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EU GMP Annex 16 provides guidance on certification by a Qualified Person and batch release within the European Union.
Manufacturers of medicinal products within the European Union are required to comply with EU GMP Annex 16.
EU GMP Annex 16 must be filled out by following the guidelines provided by the European Medicines Agency.
The purpose of EU GMP Annex 16 is to ensure that medicinal products are manufactured and released in compliance with Good Manufacturing Practice standards.
EU GMP Annex 16 requires information related to certification by a Qualified Person and batch release of medicinal products.
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