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

 
 
TOP 5 GMP Downloads

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

 

2. Quality Agreement
Standard draft to adapt and extend

 

3. Premises
Official requirements | material flow | room classes | and much more...

 

4. GMP Audit Checklist
for Pharmaceutical and API Manufacturers

 

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

 

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 find more Downloads!

 

News about GMP/cGMP

EMA: Work Plan 2012

The European Medicines Agency (EMA) released the work programme for 2012.

 

In 2012 the Agency will focus on the following topics:

  • Implementing new pharmacovigilance legislation
  • Implementing revised policies on handling conflicts on interests
  • Ethical and practical GCP (Good Clinical Practice) aspects of clinical trials
  • Progress of Agency interactions with healthcare professionals
  • Supply shortages of medicines caused by insufficient GMP compliance. EMAs Management Board initiated the discussion on a "Reflection paper on medicinal product supply shortages caused by manufacturing/GMP compliance problems".
Outcome:

EMA will publish a detailled work plan in January 2012. The "Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU regulatory authorities" will be presented to the Heads of Medicines Agencies for endorsement in February 2012 as a final step.

Source:

EMA/ Announcement

 

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