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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
Draft Guideline: Evaluation of Medicinal Products
Following adoption of the Note for Guidance on evaluation of medicinal products indicated for the treatment of bacterial infections (CPMP/EWP/558/95 rev 1) it became apparent that some areas of the guideline would benefit from further explanation of the requirements for approval of new antibacterial agents and for significant variations to the marketing authorisation.
This Guideline considers the microbiological and clinical data required to support indications, dose regimens and durations of therapy for antibacterial agents and the layout and wording of some sections of the Summary of Product Characteristics (SmPC). It applies to the initial development programmes for new antibacterial agents and to data generated to support additions and changes to the clinical and microbiological elements of the marketing authorisation. A detailed description of the design of studies that might support individual types of indications is not provided.
Replacement:
This guideline replaces guideline CPMP/EWP/558/95 rev 1.
Outcome
Check the complete Draft Guideline. Comments should be provided using the template linked to the draft guidance. Send your comments to EWPSecretariat@ema.europa.eu Deadlines for comments: August 31, 2010.
Link:
EMA/ Draft Guideline