What is the [Current] Desired Level of CGMP Compliance?
The 10th December 2019 was a remarkable day for several reasons, in Washington, DC. In one part of the United States Congress, the question – what is the desired level of compliance with CGMP, was posed repeatably to two witnesses, under oath. These witnesses were Doctors Janet Woodcock and Mary Denigan-Macauley representing the US FDA and the US Government Accountability Office (GAO), respectively (1,2). Those questioning the professionals were the Representatives of the US Citizens, members of the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives. The topic of the hearing was “Securing the US Drug Supply: Oversight of FDA’s Foreign Inspection Program” (3).
“Hearings” are for listening – did you hear the voices of the representatives? If not, consider reviewing the available session on the internet (3). While looking at and listening to a live stream, I could not help but reflect on the early days of ValGenesis – why the name “ValGenesis”?
Validation & Valid
Standard dictionary (4) meanings of the noun ‘validation’ are:
- The action of checking or proving the validity or accuracy of something
- The action of making or declaring something legally or officially acceptable
- Recognition or affirmation that a person or their feelings or opinions are valid or worthwhile
Today, are we comfortable to accept the use of the adjective valid? The answer to this question depends on the context, personal, professional, and public. Since the 16th century, the collective meaning of the adjective valid has evolved etymologically. From having force in law and legally binding, to sufficiently supported by facts or authority and well-grounded, and to the current general broad meaning in the life-science sector – the documentary evidence demonstrating that a procedure, process, or activity, when carried out yields expected outcomes and maintains a desired level of compliance.
The regulatory action of making or declaring something legally or officially acceptable depends on professionals taking actions in a corporation of checking or proving the validity of data and information. Knowing how to provide evidence of integrity and quality over a product life-cycle demands that professionals recognize and affirm that they, their feelings, opinions, and know-how are valid. In the 21st century, the suitability and capability of professionals and processes are essential to validation.
Validation is personal, professional, and public! Going “paperless” is then crucial to progressing on the 2020-2030 journey. So it is clear, on reflecting on the early days of ValGenesis –why the name “ValGenesis” is so appropriate for a 100% Paperless Validation Lifecycle Management System.
- The US FDA. Testimony of Janet Woodcock, MD. Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives. December 10, 2019. https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Updated%20Testimony%20-%20Woodcock%20%28FDA%29%2020191210.pdf (Accessed 11 December 2019)
- US GAO. Statement of Mary Denigan-Macauley. Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives. Preliminary Findings Indicate Persistent Challenges with FDA Foreign Inspections. December 10, 2019. https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Testimony%20-%20Denigan-Macauley%20%28GAO%29%2020191210.pdf (Accessed 11 December 2019)
- The US House of Representatives. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations. Hearing on “Securing the U.S. Drug Supply Chain: Oversight of FDA’S Foreign Inspection Program.” December 10, 2019. https://energycommerce.house.gov/committee-activity/hearings/hearing-on-securing-the-us-drug-supply-chain-oversight-of-fda-s-foreign (Accessed 11 December 2019)
- 4. Lexico.com, a collaboration between Dictionary.com and Oxford University Press https://www.lexico.com/en/definition/validation (Accessed 11 December 2019)
About the Author
Dr. Ajaz Hussain, Ph.D.
Advisory Board Chairman & Board Member of ValGenesis
Dr. Ajaz Hussain is a distinguished contributor and acknowledged leader in the advancement of pharmaceuticals, regulatory science, and drug development. During Dr. Hussain’s tenure at the FDA, as Deputy Director, Office of Pharmaceutical Science, he led the FDA efforts on Process Analytical Technology (PAT) Initiative and CGMPs for the 21st Century. He was the FDA’s lead for Quality ICH negotiations and the establishment of ICH initiative on Pharmaceutical Quality for the 21st Century (ICH Q8, Q9, and Q10). He has served as the President of the National Institute for Pharmaceutical Technology & Education (a not-for-profit collaboration among leading American universities), as the principal of his consulting company Insight, Advice & Solutions. He has also held several senior management positions including CSO & President of Biotechnology at Wockhardt, Chief Scientific Officer at Philip Morris International, VP & Global Head of Biopharmaceutical Development at Sandoz, and Associate Professor of Pharmaceutics at the University of Cincinnati’s College of Pharmacy.