Never ever a 483?
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but we know that the GMP MANUAL includes all
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GMP compliant.
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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
Rx-360: Supply Chain Security White Paper
The papers, created by Rx-360 member company supply chain security experts, provide an overview of considerations and approaches for addressing security risks that may occur through use of third party Logistics Service Providers (LSP), and provide practical tools that help clarify expectations and responsibilities of both manufacturer and LSP regarding a risk-based security program.
As mentioned by Jeremy Baumann, Supply Chain Security Manager at Takeda Pharmaceuticals, the aim is pursued to give any pharmaceutical company the tools necessary to develop a supply chain security program with external warehouse and distribution partners.
The documents can be accessed by clicking the links below: