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GMP Inspections in Europe: Proven Strategies on How to Prepare

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1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


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More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


3. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


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News about GMP/cGMP

Rx-360: Supply Chain Security White Paper

Rx-360 has released the "Rx-360 Supply Chain Security White Paper:  Audits and Assessments of Third Party Warehousing and Distribution Facilities," a Template of Requirements for Third Party Logistics Service Providers, and an Audit Tool focused on Third Party Logistics Service Providers.


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:


Rx-360 Press Release

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