Pharmaceutical Manufacturing Dashboard 2017 Review

1. Case Study
Accuracy and Integrity of the Data to support the
Safety, Effectiveness and Quality of Drug
October 2017
US-FDA
Obaid Ali, RPh. M.Phil, Ph.D.
Civil Service Officer, Government of Pakistan

2. Comprehensive Investigation into the extent of
Inaccuracy in Data Records and Reporting
1/4
Detailed investigation, protocol & methodology
Summary of all laboratories, manufacturing operations &
system to be covered by the assessment
Justify if exclude any part of operation

3. Comprehensive Investigation into the extent of
Inaccuracy in Data Records and Reporting
2/4
Interview of current & former employees
To identify the nature, scope & root
cause of data inaccuracy
Through qualified third party

4. Comprehensive Investigation into the extent of
Inaccuracy in Data Records and Reporting
3/4
Assessment of data integrity deficiencies
Identify omissions, alterations, deletions,
record destruction, non-contemporaneous
record completion etc.
All operations discovered with data integrity lapses

5. Comprehensive Investigation into the extent of
Inaccuracy in Data Records and Reporting
4/4
Comprehensive Retroscopic Evaluation
Nature of data integrity deficiencies
through third party with specific
expertise in the area
At all potential breaches

6. Every deficiency has an impact on patient
health, your own promise and
product performance
Don’t let it go, assess accurately and sincerely, be aware
Take Home Message
Set the Tone on Full Compliance Mode