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Data Integrity: TGA Expectations

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

• 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

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
– 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

• 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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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