India pharma 2017 Data Integrity Panel Key Points

Opening remarks: Key points Ajaz S. Hussain, Ph.D.

2/11/2017 © Ajaz S. Hussain | Insight, Advice & Solutions LLC 1

Panel Discussion 1: Data Integrity Re-visited: Challenges and Solutions

Panel Discussion 1 : Data Integrity Revisited: Challenges and Solutions Session Moderated by : Shri S.M. Mudda, Director-Global Strategy (Technical), Micro Labs Ltd


Session Constituents :

Dr. Eswara Reddy, Joint Drug Controller (India), Central Drugs Standard Control Organization

Dr. Mathew T Thomas, Director, USFDA India

Dr. Deus Mubangizi, Group Lead, Inspection Services, WHO 4)

Dr. Ajaz S Hussain- President, National Institute for Pharmaceutical Technology & Education (NIPTE) & Founder CEO at Insight Advice & Solutions LLC

Dr. Ranjana Pathak, Global Head, Quality, Cipla Limited

Dr. Antony Raj Gomas, Senior Vice President- Quality, Mylan

Shri KM Prasad, Managing Director, Karnataka Antibiotics and Pharmaceutical Limited

Year 2016 has seen resurgence of Data Integrity violations with reported 136 regulatory actions taken worldwide.

The incidence of Warning Letters is more than doubled between year 2015 and 2016.

• Increased regulatory focus and inspectional capacity and capability

What are the underlying

contributing factors for this increase?

• Yes, increasing detection in GLP setting and globally

Whether the Breach of Data Integrity (BDI) is seen in newer areas, sectors and regions?

• Causes of BDI range from unintentional (errors) to intentional (Cheating by Design); it difficult to conclude global similarity or lack thereof

Are the causes similar or disparate when

compared globally?


A number of guidelines have been published on this subject by almost all major regulatory agencies that emphasize on introduction of Data Governance System over data life-cycle covering number of Organizational Controls & Technical Controls.

• At minimum, in the USA context, 21 CFR Part 11 complaint IT systems across R&D to Manufacturing to Pharmacovigilence

What kind of Data Governance System should we create to ensure integrity of data through the

Product Lifecycle?

• Many companies now have a dedicated group and leadership commitment to Data Integrity; “we make two products –medicine and evidence!”

Whether the global industry is moving towards creating a Data Governance System and with

what rate of success?


These [Regulatory] Guidelines also focus on Code of Ethics & Policies, Adoption of Pharmaceutical Quality Management System and Science & Risk -based Approaches, Organizational Influences on successful Data Integrity Management and ultimately Fostering Quality Culture as key enablers for ensuring Data Integrity.

• Remove “fear” of making and reporting mistakes with supervisors engaging daily as coaches – actively work to discourage Sala mien to Saab nan gaya attitude.

What preventive measure should companies initiate to create a culture of quality, encouraging a ‘Speak‐ Up’

culture?

• Developing “Quality” leadership is important; however, it is essential that all (CEO, R&D, OPS, Quality) take responsibility for Quality! To do so remove “blind spots”.

Whether companies are developing second level quality leadership for fostering culture

of quality.

• Effective Culture of Pharmaceutical Quality Training Top –to –front lines is essential; a case example of success story in Bangalore should now be visible

Are there any examples which you wish to share that have

really enabled in winning the trust back of the regulators

and the customers by adopting these approaches?


Deloitte survey reveals that 52% of the compliance issues stem due to non-availability of skilled and trained staff, and inadequate training to employees on quality and other aspects of compliance.

• For those at the at the front-lines training to ensure understanding of “why we do what we do” and “how do we know what we know” are essential. Current “SOP” training programs tend to be too “superficial” and ‘casual”.

What are your views on creating a skilled

workforce?

• Education, Training, Experience as in the US 21 CFR 211.25 is in need for a major improvement and emphasis in the context of Quality by Design and Continued Process Verification with Statistical Confidence. A major for on “Education, Training, Experience” will be critical for business sustainability

Whether continuous advanced education programs will help in

creating skilled competent future professionals by

inculcating the values of integrity and ethical

behavior?


https://www.linkedin.com/pulse/education-training-experience-21-cfr-21125-theory-hussain-ph-d-

https://www.linkedin.com/pulse/education-training-experience-21-cfr-21125-theory-hussain-ph-d-

We quite often see that the companies which succeeded in a follow-up inspection through intense remediation are again seen to falter in the subsequent inspections.

• Typical/traditional 3rd party remediation focuses primarily on “SOP documentation”; the underlining root-causes are often not adequately addressed (for many reasons)

What is the role of third party remediation and

advice for the companies for doing an effective and sustainable remediation

programs?

• Systems approach to quality management is essential; QMS is much more than a folder of SOP’s and Policies (sometimes written by 3rd

party consultants for 3rd party regulators). A company which does not take within the ownership and responsibility for quality will not be sustainable

Whether the remediation happens within or outside

of quality system as a standalone exercise as

against a global remediation driven through

quality system aimed at providing a sustainable

compliance solution?


Some of the surveys and analysis of the regulatory actions carried out quote the extent of Data Integrity issues of year 2016 ranging from 33% to 80%.

• Not familiar with the surveys referred to. Based on my practice – the potential for negative consequences (to patients) of BDI are not appreciated to large extent.

Does this vast gap indicate variability in understanding of

what constitutes Breach of Data Integrity?

• Attributable, Legible, Contemporaneous, Original and Accurate are the essential foundation of data integrity; any deviation are and should be recognized as a BDI.

Whether situations of failure to comply with Data Quality

Attributes (Originally represented by an acronym

ALCOA), are being considered as potential cases of BDI?

• Integrity of data is the foundation upon which science based risk assessment is possible. Do not put the cart before the horse!

Whether adoption of risk-based approach during

inspection and assessment keeping patient safety in mind would reduce such perceived

gaps of interpretation?


What are your views on mechanisms for identifying the potential data integrity issues and encouraging transparent escalation to the appropriate level of management?

• CEO/MD led & sustained effort to remove fear + an effective “whistle blower” system is an important contributor for minimizing BDI.

Will ‘Whistle Blower’ system be of any

assistance?

• Zero tolerance for the Sr. VP’s and VPs should be a consideration; but not for those on the front-lines.

Do you think that zero tolerance approach or

termination of the employees responsible for the issue will improve the

situation?

• It is unfortunate that regulator heterogeneity continues to high. Message to regulators- Integrity of data is the foundation upon which science based risk assessment is possible. Do not put the cart before the horse!

Whether there is an agreement in the

approaches to be adopted by different regulatory

agencies?


What are various software solutions available to ensure authenticity and reliability of data?

Electronic lab note books – to validation data management system – batch records – pharmacovigilance …..

• Generally not a difficult task in the context of IT system implementation; our habits are hard to change.

What are the challenges of

switching over from manual systems to electronic systems?

• Ensure effective utility of the IT system (to be) installed; seek end to end connectivity to facilitate information and knowledge transfer that makes science based risk assessment easy to and contributes to effective CAPA

What advice you would like to give to

the industry for implementing

software based systems?
