1ST FEB, 2021
Good
Distribution Practice for Medical Device (GDPMD)-
From Guideline to Implementation
By Nur Syafiqah Saleh.
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6 Steps to Import Medical Device
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Make sure you have Summary of GDPMD Document
Are you ready?
General Establishment shall
•Explain entire QMS be consistent with GDPMD clause
•Map clearly to show the interaction of GDPMD process
•Prepare Master Document List (SOP/WI/Std) to show both operation & control are effective & compliance.
•Management review, Internal & External Audit every year to monitor, measure & analyse these processes.
•Keep traceability records file.
•Identify & control qualified to outsource to ensure regulatory compliance.
Handling Approval
Reviewed
Created
Revised
Distribute
7. Documentation Control
26. Traceability
27. Specific Traceability Requirements for Implantable Medical Devices
39. Distribution Records
Continues practice ensuring the documents are...............of in a systematic, verifiable manner
Release
Storage
Production
We do the necessary steps to deliver the result.
Disposed
The GDPMD documentation is structured into 4 levels, namely:
Level I
Regulatory Compliance Manual (RCM)
The manual outlines the regulatory compliance system with reference to the GDPMD requirements.
Level II
Procedures
Process flow.
Level III
Work Instructions (If required)
Provide specific instructions.
Level IV
Forms/Records and Checklist
Records and checklists are formats designed for demonstrating conformance to the regulatory compliance system, product and process quality...
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