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How to Meet the GMP Requirements of Annex 16 EU GMP Guide
Batch release is complex and challeging due to requirements, responsibilities and the global product flow. Make sure to safely circumvent the multiple pitfalls that lie in wait.
1st edition 2018
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Excerpt from the GMP Compliance Adviser Batch Release is the most relevant step in the lifecycle of a medicinal product. The revised version of Annex 16 of the EU GMP Guide regulates in detail the batch release, especially the activities that the certifying Qualified Person is responsible for. The process is divided into three separate steps:
Requirements, responsibilities and the global product/process flow are complex and challenging. The e-book How to Meet the GMP Requirements of Annex 16 EU GMP Guide helps you to safely circumvent the multiple pitfalls that lie in wait. You will get answers to the questions:
Order your copy of How to Meet the GMP Requirements of Annex 16 EU GMP Guide and learn the best practice of batch release.
Reading Sample "EU-Compliant Batch Release of Medicinal Products"
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