• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
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

2010-03-25

EDQM: Related Substances

As the requirements for related substances in Ph. Eur. monographs have been adapted in accordance with the principles of ICH Guideline Q3A(R2), there is a need for more appropriate format for quantitative purposes. The Chairs of EDQM's Chemical Groups have developed a model text to which new or revised monographs would be adapted.

 

In European Pharmacopoeia monographs, the acceptance criteria for related substances have so far usually been expressed in terms of comparison of peak areas (“… not more than the area of the principal peak in the chromatogram obtained with reference solution …”), which, strictly speaking, leads to a pass/fail decision but not to a true quantitative test result.

Outcome:

Send your comments to the appropriate national pharmacopoeia authority. Readers from countries that are not members of the European Pharmacopoeia Commission should send their comments directly to the European Directorate for the Quality of Medicines and HealthCare (EDQM). Comments on this proposal should be submitted by 30 May 2010.

Source:

EDQM/ Announcement and Model Text

Comments
No comment has yet been written about this news.