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recent MHRA Findings

GDP 2019.PNG

The MHRA review of their inspection findings for 2019 shows a new (?) inspection emphasis. The findings are ranked below in order. As you can see the data integrity principles are starting to show through more in 2019:

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1 Production controls and instructions

2 Contemporaneous record keeping

3 Approved and signed off documents

4 Record keeping

5 Review of quality documents in a timely manner

6 In process controls

7 Document control

8 Management review

9 Change control

10 Design of documents

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If you have of these issues I can help you improve !

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