Quality Management Systems in Drug Safety
Quality is defined as one of the areas that are relatively new to drug safety and pharmacovigilance (PV). It is no longer enough to do a good job and know you’re doing a good job, but now this must be documented and reviewed by overseers to ensure that, you really are doing a good job! In fact, one might say that, after x years of doing drug safety, “I know how to do this!” But if one thinks about it, it is always worthwhile having another set of eyes look at someone’s work to be sure no issues or errors have slipped in. We certainly want someone to double check airplanes and the pilot before take-off or the functioning of nuclear reactors. So now we have it in the drug safety spectrum. With drug safety evolving into a key priority area for the biopharmaceutical industry, the emphasis on quality and compliance has increased substantially. As regulatory oversight of company safety activities for approved pharmaceutical products becomes more holistic than simply assuring adequate and compliant procedures that meet legal obligations, the system is being transformed into one that is more proactive, robust and more clinically useful.
Each company should have a quality management system (QMS) which includes a mission statement of the goals and scope of the program as well as defining applicable laws, regulations and, importantly, best practices (procedures where the law is unclear or silent). In addition, there should be written, versioned procedural documents (SOPs, Manuals, and Work Instructions etc.). It is a good idea to create a corporate “Quality Manual” summarizing, at a high level, the company’s intent to maintain top quality.QMS should make it simpler for companies to comply with the law and to help prevent harm to human subjects and patients. Biopharmaceutical companies are required to promote the safe use of drugs and protect patient and public health. QMS should address quality planning, quality adherence, quality control/quality assurance and quality improvements. Compliance management s an overarching component which encompasses processes and procedures. It pertains to having controls in place to manage compliance with requirements of the Competent Authorities (CAS) around quality, completeness of PV data, assessment and timeline compliance, independence of PV activities and effective communication.
A key element of compliance management is to have the right technology and valid, traceable processes with audit trails. Other aspects of compliance management are defining and monitoring of key performance indicators (KPIs), ensuring root cause analysis (RCA) and corrective and preventive action plans (CAPA) and conducting periodic audits. It also includes effectiveness measures for actions taken to minimize risks and support their safe and effective use of the medicinal products in patients. Here must be a commitment by management to quality and they should lead by example. They should communicate this policy, receive and respond to feedback and maintain a customer focus noting that the concept of “customer” is broadly defined to include not just patients and health care providers but many others such as health authorities, and internal company clients. Management should ensure that planning and the quality system are put in place.
The broad area of planning, processes, controls, and execution plays an important role where the company should be prepared and anticipate issues and problems. This may be hard in PV where spontaneous reports determine one’s workload and fate. Explicitly or implicitly, all guidance’s have similar expectations from a QMS. For QMS to provide its real worth it needs to be more than a mere obligation or mandate, it needs to be a living system with a real impact on the PV system. By laying out the framework for the PV system, the implementation of a QMS can ensure that compliance and quality are delivered without exception. Every company has to have a quality system in place. The health agencies will inspect and punish those who don’t.
