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
CEP-Certificates: Update on Application Forms
In order to re-enforce the obligation of CEP holders to inform their customers in case of CEP revision, CEP suspension, withdrawal or negative outcome of an EDQM inspection, a commitment that needs to be signed by the applicant has been included in the CEP application forms for new applications and revisions/renewals. The signature of this commitment will be part of the criteria for validating the applications at receipt.
Moreover, following the revision of the system for revision/renewal of CEPs, the revisions/renewals application form has been updated accordingly. The revised form includes new categorisation tables and a revised invoicing sheet.
There are two downloads of updated documents:
- Application Form - Request for new Certificate of Suitability
- Application Form - Request for Revision or Renewal of Certificate of Suitability
Outcome
Use the updated forms provided by EDQM from March 1, 2010.
Links
EDQM/ Announcement
EDQM/ Application Form - Request for new Certificate of Suitability
EDQM/ Application Form - Request for Revision or Renewal of Certificate of Suitability