Governance in the Health Industries
Drawing on his long experience as a senior QA executive in various companies, Steve Biddulph connects Quality Assurance & Good Governance, and suggests how the former can help the latter. A future article will focus on Business Oversight.
Poor corporate governance and oversight are frequently cited factors in Observations of poor quality and non-compliances, by Regulatory agencies, particularly FDA investigators following (GMP, GCP and PAI) inspections.
Official enquiries into major tragedies in other industries often mention poor corporate governance and oversight. What is meant by this?
Governance is the way in which companies decide to run their business, with their ways of working enshrined (or not!) in a series of company policies, covering all functions and activities internally and externally. Governance will include Quality & Regulatory activities, Finance, Personnel Management, R&D, Marketing, Procurement, and Legal.
Good Governance requires managing in a responsible and ethical manner, all areas of activity. It requires:
- Integrity – with all standards applying to a company’s activities being communicated & put into practice by all concerned parties via company policies. The standards must ensure that the ways of working are defined; taking into account the different cultures & socio-economic environments of third parties. These policies must be communicated internally & also to exterior stakeholders.
- Responsibility and accountability – within the company’s organisation being clearly defined.
As a result, the company’s personnel can be expected to accept, and act in accordance with their responsibilities; and face accountability.
These principles find their counterparts in legal, financial , and regulatory mechanisms in many developed economies.
Our experience in QA, Regulatory Compliance, & Project Management shows successful policy execution is achieved with the help of full transparency on strategy, objectives and individual actions to be taken, plus training, communication and collaboration.
In the Pharmaceutical Industry Good Governance starts with basic research, & continues through development, non-clinical, clinical, registration, manufacture, distribution and post marketing surveillance; in order to ensure consistent and appropriate product quality, patient safety, and compliance with relevant regulatory and legal requirements.
Good Governance has been given a boost – via communication with exterior stakeholders, including “society” – by the current trend for ESG investing. Essentially this means investing in companies which are judged to protect the Environment, promote Sustainability, and show good corporate Governance.
Having discussed Good Governance, in the next article we will turn our attention to Company Oversight.
Should you require further information on Good Governance and how to successfully improve or implement it in your company or function, then please contact Galenisys.
The big roll-out 2021
We can expect next years headlines to major on the manufacture, distribution, & use of the vaccines post stage 3. Here at Galenisys we’ll be following the roll-out with particular interest, having helped several of the sites which are now gearing up, with assignments to observe sterile suite behaviour & techniques and / or remediation and / or audits. We wish them well.