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
Quality by Design (QbD)
The 28 questions and answer are covered by 5 sections:
I. Effective communication between Suppliers and Users
II. Development of the Dosage Form
III. Questions related to excipients CQAs
IV. Equipment and Production related Questions
V. Supply of Samples
"This Questions and Answers (Q&A) document has been elaborated by a small working group consisting of representatives both from the suppliers and the users. It has been put in place to advise and give guidance on general questions that may need to be addressed at an early stage and to try and harmonise possible answers/comments from both sides in order to facilitate and rationalise in the starting up of collaboration in this field. The Q&A should be viewed as a living document and will be updated as more experience is gained by both parties." (IPEC)
IPEC Questions & Answers on Quality by Design (QbD)
Source: IPEC (www.ipec-europe.org)