• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

If you’d like to be regularly informed on the latest developments in Good Manufacturing Practices


>>> REGISTER for our free GMP Newsletter LOGFILE

GMP Inspections in Europe: Proven Strategies on How to Prepare

>>> More information

TOP 5 GMP Downloads

1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


3. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance


>>> Click here to find more Downloads!

News about GMP/cGMP

EMEA publish Q&A on Calculation of Thresholds for Impurities

Question: What is the basis for the calculation of thresholds to set limits for impurities in the finished product specification?



The calculated thresholds should be based on the highest maximum daily dose of the respective active substance in authorised medicinal products. The threshold for impurities should be the same for all strengths.

The same rule applies for combination drugs; the highest possible combined strength should be used for setting the thresholds.

The maximum daily dose used for threshold calculation should be the same for a given active substance irrespective of the medicinal product.

Source: EMEA - Inspections - Quality Working Party - Questions & Answers, July 30, 2009

No comment has yet been written about this news.