Data Integrity in Pharmaceuticals
By
M. Satya Babu Ph.D.,MBA
Vice President & Head – Corp Quality
Granules India Limited
Contents
• Definition and Basics
• Regulatory Requirements
• Increased focus of Regulators – A paradigm shift
• Basic reasons – Behaviour Based Quality
• Current challenges
• Framework for prevention of data integrity issues
M. Satya Babu Ph.D., MBA 10th Feb 2016 2
“Generating, transforming, maintaining and assuring the accuracy,
completeness and consistency of data over its entire life cycle in compliance
with applicable regulations”.
How can we define Data Integrity…
M. Satya Babu Ph.D., MBA 10th Feb 2016 3
The Acronym ALCOA
Attributable
Legible
Contemporaneous
Original
Accurate
Complete
Consistent
Enduring
Available
M. Satya Babu Ph.D., MBA 10th Feb 2016 4
Increased focus of Regulators – common issues
• Not recording activities contemporaneously
• Backdating
• Fabricating data
• Copying existing data as new data
• Re-running of samples/ Duplicate runs / trial runs
• Discarding of data
• Releasing failing product, insufficient investigations
• Testing into compliance
• Not saving electronic data
M. Satya Babu Ph.D., MBA 10th Feb 2016 5
• Mind-set
• Attitude
• Lack of Quality Culture
• Lack of Management Commitment and Vigilance
• Insufficient Resources
• Infrastructure (equipment/facilities/instruments etc.)
• Robustness of Processes
• Ruggedness and Robustness of methods
• Lack of manpower ..yet fixed targets
• Poor training levels
Basic Reasons
M. Satya Babu Ph.D., MBA 10th Feb 2016 6
• Lack of automation
• Lack of detectability, Quality of in-process checks/reviews
• Quality of manpower and systems
• Poor change management system
• Lack of ownership and accountability
‘Personnel’ is the biggest variable in the entire process and largely decides the level of
compliance. It is totally dependent on COMMITMENT, BEHAVIOUR and QUALITY
CULTURE
Basic Reasons
M. Satya Babu Ph.D., MBA 10th Feb 2016 7
Behaviour Based Quality (BBQ)
Core character
Values, Beliefs
Attitudes
Feelings
Behaviour
Cross section of a human being
M. Satya Babu Ph.D., MBA 10th Feb 2016 8
Behaviour Based Quality (BBQ)
• Understand the knowledge levels, beliefs and culture
• Understand the mind-set of personnel
• Relate the corporate goal to their behavioural traits
• Have meticulous in-process checks and reviews
• Provide constant feedback/education/training to make them aware how a data integrity issues can damage the individuals and the organization
• Understand their pain points. Build the trust and resolve them
• Make them part of problem solving and reward suitably
• Motivate them. Reward and Recognize suitably
M. Satya Babu Ph.D., MBA 10th Feb 2016 9
How can we prevent them ?
• Perform a complete gap analysis w.r.t
• Personnel
• Systems
• Resources
• Equipment/infrastructure
• Training /skill level
• Reduce the human intervention and manual recording to the maximum extent
possible
• Digitalize the activities leaving no room for short-cuts and to increase the
detectability
M. Satya Babu Ph.D., MBA 10th Feb 2016 10
• Identify the key areas to be monitored and implement digitalized systems for data
capturing and for prompting the personnel to pay attention
• Fix the process issues, repeated failures and non-conformances
• Understand the pain points and fix them
• Provide constant training to staff, introduce checklists and monitor them closely.
• Introduce the system for data integrity checks/compliance audits by trained personnel
• Define the access level to data, roles and responsibility, rigorous document control and
review mechanisms.
How can we prevent them ?
M. Satya Babu Ph.D., MBA 10th Feb 2016 11
In Summary,
• Management Commitment is the first step
• Gaining the individual’s commitment, change of mind-set, culture and
attitude is equally important.
• Procedures, instructions, protocols are baseline documents. Adopt behaviour
based quality system for better results.
• Fix legacy issues before we demand for full compliance and no data integrity
issues. That way we can gain the respect among team.
• Mistakes can be addressed not the Manipulations/falsifications
• Identify the potential areas, digitalize them leaving no room for short-cuts
• Have structured compliance reviews, data integrity audits
• Have Quality Metrics in place. Inculcate the culture of Quality
M. Satya Babu Ph.D., MBA 10th Feb 2016 12
My sincere thanks to
• Phamexcil , Dr. Appaji and Team
• Mr. B Madhusudan Rao, COO , Granules India
• Management of Granules India Limited
Thank You