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. GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

 

2. GMP Audit Checklist
for Pharmaceutical and API Manufacturers

 

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

 

4. Risk Management
established methods of risk analysis
incl. ICH Q9

 

5. Preparing for the EU GMP Inspection
similarities - and subtle differences - between FDA and EU GMP inspections

 

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

New Part III EU GMP published (EC)

On Feburary 7, 2011 the European Commission (EC) published the new Part III "GMP related Documents" of the EU GMP Guide.

 

The EC adopted the Rules for establishing a Site Master File developed by the PIC/S.

The EC's notes are intended to provide guidance on the recommended content of a Site Master File. A requirement for a Site Master File is is referred to in Chapter 4 of the GMP Guide.

Outcome:

You can download the new Part III  "GMP related Documents" here. This document will be part of the next update of the GMP MANUAL (May 2011).

Source:

EC/ EU GMP Guide Part III

Comments
No comment have jet been written about this news