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
Q8, Q9, Q10 Questions and Answers (FDA)
The documents presents questions and answers to several topics:
A. For General Clarification
B. Quality by Design (QbD) Topics
- 1. Design Space
- 2. Real-Time Release Testing
- 3. Control Strategy
C. Pharmaceutical Quality System
D. Impact of New ICH Quality Guidance on GMP Inspection Practices
E. Knowledge Management
F. Software Solutions
Outcome:
The complete questions and answers document can be found here.