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
Lack of Hygiene
The situation took place during a FDA Inspection of a food-manufacturers facility and there are several analogies to the pharmaceutical manufacturing you can learn from.
Outcome
- Clean and sanitize utensils and equipment in a manner that protects against contamination of drugs, drug-contact surfaces, or drug-packaging materials!
- Ensure that convey, store, and dispose of rubbish and any offal happens in a manner that protects against contamination of drugs!
- Your plant and facilities must be constructed so that drip or condensate from fixtures, ducts, and pipes does not contaminate drugs, drug-contact surfaces, or drug-packing materials!
- All persons working in direct contact with drugs, drug-contact surfaces, and drug-packaging materials must conform to hygienic practices to protect against contamination of drugs!
Check FDA's Warning Letter to learn more about negative effects coming from lack of Hygiene and how to avoid them!
Source
FDA/ Warning Letter