Data Quality and Data Integrity - Audit Trail - Part 11 - WHO - FDA - MHRA - PDA

v9991

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#1
having dome some work on risk-based-auditing (sharing the audit reports across agencies ); agencies are now preparing the ground for 'quality metrics'.

and that preparation seems to be with focus on 'data quality and data integrity' ; anyways for the metrics to work, the data reliability is crucial.:agree::read:

FDA :- Data Integrity and Compliance With CGMP

WHO :- GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES

MHRA :- MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015

PDA :- Data Integrity

Elements of a Code of Conduct for Data Integrity in the Pharmaceutical Industry
 

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Elsmar Forum Sponsor

SGquality

Quite Involved in Discussions
#3
I always had this question ... in case of the FDA guidance document on Data Integrity, it states at the bottom of the page 1:

Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
Pharmaceutical Quality/Manufacturing Standards (CGMP)

There is no mention of CDRH; so does that mean that the medical device companies need not follow this guidance document ?

Thank you !
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I always had this question ... in case of the FDA guidance document on Data Integrity, it states at the bottom of the page 1:

Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
Pharmaceutical Quality/Manufacturing Standards (CGMP)

There is no mention of CDRH; so does that mean that the medical device companies need not follow this guidance document?
From that document:

I. INTRODUCTION
The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.
Those parts don't apply to medical devices manufacturing.

The cGMP equivalent for medical devices is part 820.
 

v9991

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#5
from perspective and context of bringing the guidance in place..... these are outcome of series of audit observations of agency...wrt traceability & compliance of QMS to respective site-SOPs and also wrt respective guidelines.

by book, since these are not yet adopted by CDRH, its not mandated;

my take :- :2cents:
1) 'integrity' is 'implicit' & 'given'; if&once we see these guidance as 'set of good practices' these are relevant for all QMS.

most of the emphasis is on approach towards 'system/compliance by design'; it will only add to the confidence/reliability of the implementation.

2) after integrity (if not, more than integrity) the emphasis on compliance has to move onto 'effectiveness' this is initiated through 'quality metrics'guidance.

Here's another updated MHRA guidance document on same subject.
 

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v9991

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#6

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R

ricky07

#7
Good information, very useful.:applause:

just wondering if there is any specific information on use of ERP (SAP) and data integrity pitfalls. I am thinking of Pdf attachments to SAP. Is this an area of concern or common in industry?
 
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