Data Integrity: TGA Expectations
Discussion Topics
What is Data Integrity?
• Global/Australian/US FDA Environments
• Data Integrity General Examples
• Basic Data Integrity Expectations
• ALCOA Principles
• TGA Licensed Manufacturers Expectations
• Conclusions
What is data integrity?
• The extent to which all data are complete, consistent and accurate throughout the data lifecycle
• From initial data generation and recording through processing (including transformation or migration),
use, retention, archiving, retrieval and destruction.
Australian Environment: Inspection report
• DEFINITIONS
• Critical Deficiency
• A deficiency in a practice or process that has produced, or may result in, a significant risk of producing a
product that is harmful to the user. Also occurs when it is observed that the manufacturer has engaged
in fraud, misrepresentation or falsification of products or data.
Data Integrity: General Examples
• Human errors ————— Need to know the difference between falsification and poor/bad GMP/practice
– data entered by mistake
– ignorance (not being aware of regulatory requirements or poor training)
– Wilfully (falsification or fraud with the intent to deceive)
• Selection of good or passing results to the exclusion or poor or failing results
• Unauthorised changes to data post acquisition
• Errors during transmission from one computer to another
• Changes due to software bugs or malware of which the user is unaware
• Hardware malfunctions
• Technology changes making an older item obsolete – old records may become unreadable or
inaccessible
Basic Data Integrity expectations – Manufacturing Principles
• PIC/S Guide PE009-8:
– Chapter 4
– Annex 11
• Australian Code GMP human blood, blood components, human tissues and human cellular therapy products
– Sections 400 – 415
• ISO 13485
– Sections 4.2.3, 4.2.4
Basic Data Integrity expectations
• Regulator responses
– MHRA notifications to industry: December 2013 & March 2015
– FDA
– Health Canada
• Influencing factors:
– Organisational culture, risk awareness and leadership
– QMS design of systems to comply with DI principles
“ALCOA” principles
– Company processes for data review and system monitoring
TGA Licensed Manufacturers Expectations
• Manufacturers should:
– Design systems to prevent DI issues
Ensure the data is authentic and retrievable
– Train staff and encourage correct behaviours and practices
Open communication
Encourage feedback
– System for ongoing DI review
Conclusions
• GMP requirements already include provisions for DI- inspection report definitions, PIC/S Guide to GMP for medicinal products
• Existing systems should be able to ensure data integrity, traceability and reliability-Understand your vulnerabilities to DI issues
– The inability of a manufacturer to detect and prevent poor data integrity practices = lack of quality system effectiveness
• QRM approach to prevent, detect and control potential risks
• Where data is generated and used to make manufacturing and quality decisions, ensure it is trustworthy and reliable
• Increased regulator focus on DI
• Remember it’s the responsibility of the manufacturer to prevent and detect data integrity vulnerabilities
Reference:PPT by Stephen Hart ,Senior Inspector, Manufacturing Quality Branch, TGA
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