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Production

EU-Compliant Batch Release of Medicinal Products
€ 117.00
net
€ 139.23
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
US$
135.00
pdf download
How to Meet the GMP Requirements of Annex 16 EU GMP Guide

Excerpt from the GMP Compliance Adviser

NEW ++ NEW ++ NEW
Edition: 1st edition 2018
55 Pages
ISBN: 978-3-95807-102-5
Delivery: immediately after receipt of payment
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:
  • verification of certification requirements,
  • batch certification and
  • batch release as a change of status.
Requirements, responsibilities and the global product/process flow are complex and challenging. The report 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:
  • What does an EU-compliant batch release of medicinal products look like and what individual steps does it involve?
  • What requirements does it have to meet?
  • What requirements apply to imported products?
  • What responsibilities does the certifying Qualified Person have and how can he/she fulfil them?
  • What support systems are available to the Qualified Person?
  • What responsibilities does the certifying Qualified Person have for products fully or partially manufactured by contract manufacturers?
  • How can the certifying QP meet the challenges of a complex global product/process flow?
Order your copy of How to Meet the GMP Requirements of Annex 16 EU GMP Guide and learn the best practice of batch release.

Technical Requirements

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Filesize: 1,64 MB

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Please note the following procedure guidelines:

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  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

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  • The invoice will be sent by postal mail as soon as possible.
  • Quality assurance
  • Quality management
  • Qualified persons
Gnibl, Dr. Rainer

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-Nürnberg.

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