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
Annex 13 EU GMP Guideline published
Changes/ News:
- Revision to reinforce the principle of independence between production and quality control functions in cases where the number
- of personnel involved is small.
- Changes to sections 36 and 37 to supplement, for investigational medicinal products, the guidance for reference and retention samples
- given in Annex 19.
- An additional note has been introduced to clarify the meaning of “reconstitution” as referred to in article 9.2 of Directive 2005/28/EC.
- The content of the Batch Certificate referred to in Art. 13(3) of Directive 2001/20/EC, agreed following a separate public
- consultation, has been added as an attachment.
Link:
EC/ Annex 13