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.
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If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices
GMP Subject Downloads
1. Site Master File
A Sample for Download
according to PIC/S PE 008-4!
2. Checklist GMP-Inspections
650 questions typically asked during audits
3. Process Validation
official requirements, validation planning and procedure, ...
GMP Compliant Documentation
How to create, organize, review and archive GMP related documents in pharmaceutical industries
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News about GMP/cGMP
Draft Guidance Devices (FDA)
This draft guidance shows how to obtain information on a device and how to submit a request for information.
Outcome:
Interested persons may submit to the Division of Dockets Management written or electronic comments regarding this document.
Written Comments: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Electronic Comments: http://www.regulations.gov.
Link:
FDA/ Draft Guidance
Federal Register/ Draft Guidance