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.
Newsletter registration
PDA Parenterals Conference
From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.
This outstanding event will cover the very important topics:
- Future of Parenterals
- Packaging and Impact on Quality
- Manufacturing Flexibility and Control
- Innovative Plants
- Monitoring Technologies
- Medical and Application Devices
- Regulatory Trends
Don´t miss this interesting conference in Berlin, Germany.
News about GMP/cGMP
EMA FAQ on GMP Topics
From time to time EMA (EMEA) publishes the answers to frequently asked questions following discussion and agreement of the GMP/GDP Inspectors Working Group and they are published on this page.
There are four topics of questions and answers, covering several subitems:
- EU GMP Guide Part I Basic Requirements for Medicinal Products
- Chapter 5 Qualification of suppliers - EU GMP Guide Part II Basic Requirements for Active Substances used as Starting Materials
- GMP compliance for Active Substances
- GMP compliance for Active Substances in IMPs - EU GMP Guide Annexes - Supplementary Requirements
- Annex 1 Manufacture of Sterile Medicinal Products
- Annex 8 Sampling of Starting and Packaging Materials
- Annex 13 - Miscellaneous
- General GMP
- GMP Certificates
Outcome:
Check the information provided by EMA (EMEA), because it gives you a review on cGMP-developements and offers you first-hand information from the inspectors point-of-view.