india pharma 2017 data integrity panel key points
TRANSCRIPT
Opening remarks: Key points Ajaz S. Hussain, Ph.D.
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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
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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?
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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?
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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?
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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?
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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?
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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?
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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?
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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?
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