data integrity in pharmaceuticals · behaviour based quality (bbq) • understand the knowledge...

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…


The Acronym ALCOA

Attributable

Legible

Contemporaneous

Original

Accurate

Complete

Consistent

Enduring

Available


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


• 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


• 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


Behaviour Based Quality (BBQ)

Core character

Values, Beliefs

Attitudes

Feelings

Behaviour

Cross section of a human being


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


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


• 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 ?


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


My sincere thanks to

• Phamexcil , Dr. Appaji and Team

• Mr. B Madhusudan Rao, COO , Granules India

• Management of Granules India Limited

Thank You

data integrity in pharmaceuticals · behaviour based quality (bbq) • understand the knowledge...

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