EU-Compliant Batch Release of Medicinal Products
Enter the first customer review for this item
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.
e-book
55 pages
ISBN: 978-3-95807-102-5
1st edition 2018
Delivery immediately after receipt of payment
€117.00 net
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 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:
- 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.
Available downloads:
Reading Sample "EU-Compliant Batch Release of Medicinal Products"
- Quality assurance
- Quality management
- Qualified persons
Technical Requirements
This file is in PDF format!
Filesize: 1,64 MB
To view PDF files, we recommend using the Adobe Reader.
https://get.adobe.com/de/reader/
The e-book is password protected to prevent copying and modification of content.
Please note the following procedure guidelines:
For payment by invoice:
- You will receive an advance invoice by e-mail within 1-2 working days. You payment is required for the download.
- After receipt of payment you will receive an e-mail with the download information.
When paying by credit card:
- Immediately after the credit card payment you will receive an email with the download information.
- Your invoice will be sent in a separate e-mail within 1-2 working days.
€249.00 net
€495.00 net
€117.00 net
LOGFILE
The Newsletter of GMP-Verlag
News and upcoming trends: Stay up-to-date on the latest developments in GMP!
> Subscribe now free of charge!