gmp-verlag.de
 

Never ever a 483?

We can not promise that you will never get a 483
but we know that the GMP MANUAL includes all 
procedures and processes you need to be
GMP compliant.
 
Stay informed!

If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices

 

>>> simply register for our free GMP newsletter LOGFILE

 
 

Image

 
 
GMP Subject Downloads

BESTSELLER

1. GMP Audit Checklist
for Pharmaceutical and API Manufacturers

 

2. Documenting Process Validation
A Drugmaker‘s Guide – step-by-step manual based on real-world examination experience

 

3. Computer System Validation in the EU
a step-by-step guide to implementing a computer validation program

 

4. GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

 

5. GMP Compliant Documentation
how to create, organize, review and archive GMP related documents

 

Your benefits:

> no shipping costs
> no waiting period: if you choose payment by credit card you will receive an email with the download information immediately after payment.

 

>>> Click here to see all GMP Subject Downloads!

 

News about GMP/cGMP

EU GMP: Annex 6+13 come into operation

The European Commission has published the revised annexes 6 and 13 of the EU GMP Guideline some months ago. They come into operation on  July 31, 2010.

 

Annex 6: Manufacture of Medicinal Gases

Changes/ News:

The Annex was revised as a consequence of the restructuring of the GMP Guide and the need to modify the requirements of Part II of the Guide for applicability to medicinal gases. There was a need to define more clearly what should be considered as a starting material as opposed to a bulk pharmaceutical product. The opportunity was also been taken to update the annex in general.

Annex 13: Manufacture of Investigational Medicinal Products

Changes/ News:

  • Revision to reinforce the principle of independence between production and quality control functions in cases where the number
  • of personnel involved is small.
  • Changes to sections 36 and 37 to supplement, for investigational medicinal products, the guidance for reference and retention samples
  • given in Annex 19.
  • An additional note has been introduced to clarify the meaning of “reconstitution” as referred to in article 9.2 of Directive 2005/28/EC.
  • The content of the Batch Certificate referred to in Art. 13(3) of Directive 2001/20/EC, agreed following a separate public
  • consultation, has been added as an attachment.
Outcome:

Check the changes made by the European Commission.

Source:

EC/ Annex 6

EC/ Annex 13

Comments
No comment have jet been written about this news
 
 

Maas & Peither AG
GMP Publishing

Karlstraße 2
79650 Schopfheim
Germany

E-Mail: service@gmp-verlag.de
Tel. +49 (0) 7622 6 66 86 70
Fax +49 (0) 7622 6 66 86 77