• 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

TOP 5 GMP Downloads

1. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.

 

2. GMP Audit Checklist
Great for both sides - the auditor and the inspected company.

 

3. GDP Audit Checklist
More than 700 questions with reference to regulations.

 

4. Industry Guide to handle OOX Test Results
A concise overview of the OOX process.

 

5. GMP-Questionnaire: Contract manufacturing / Contract analysis
Standard draft to adapt and extend.

 

>>> 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?

 

Answer:

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

Comments
No comment has yet been written about this news.