EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU GMP Guide

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EU-Compliant Batch Release of Medicinal Products
How to Meet the Requirements of Annex 16 of the EU GMP Guide

The EU is very clear in its requirements for batch release… from training personnel to certify that each batch is exactly as it should be… to handling deviations in batches and dealing with shipping and imported products.

Annex 16 sets the rules for testing, certifying and releasing batches. It lays out the requirements for the role of the qualified person responsible for approving the release of every batch. But those broad strokes break into detailed processes and requirements that can be hard to interpret and even harder to follow.

EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU GMP Guide, written by EMA and GMP inspector Rainer Gnibl, walks you step-by-step through the batch release process:

  • Relevant steps for creating a batch release SOP
  • Requirements for continuous training of the qualified person
  • Interpretations and excerpts of the guidelines

The report covers critical elements of the product and process flow, strategies and tools a qualified person can use to manage supply chain, import, technical agreements and delegation.

Key Report Highlights:

  • Steps involved in EU-compliant batch release of medicinal products
  • Requirements that must be met
  • Requirements applied to imported products
  • Responsibilities of the certifying qualified person and how to fulfill them
  • Support systems available to the qualified person
  • Responsibilities the certifying qualified person has for products fully or partially manufactured by contract manufacturers
  • Ways the certifying qualified person can meet the challenges of a complex global product/process flow

Avoid missteps and delays in getting your products to market in the EU. Order your copy today.

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About the Author

As GMP Inspector for the Government of Upper Bavaria and the European Medicines Agency (EMA), Rainer Gnibl is responsible for carrying out national and international inspections of the manufacturers of medicinal products and active ingredients He is head of the national expert group EFG 02 “GMP inspections/GMP guidelines” and lectures at the Friedrich-Alexander University in Erlangen-Nurnberg.

Who Will Benefit

  • Quality assurance
  • Quality management
  • Qualified persons
  • Auditors
  • Regulatory compliance

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