Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
The Art of CAPA Writing
Posted on February 13th, 2017 by J.-P. Clement MD in Pharmacovigilance
Corrective and Preventive Actions (CAPAs) are a fundamental element of correcting deviation compliance in a regulated and quality Pharmacovigilance environment. Non-conformance to processes defined by Quality Documents (SOPs, Work Instructions, etc.), themselves deriving from applicable regulations and guidelines, can result in critical observations or worse during a regulatory authority PV inspection, and are a lingering pain, diverting resources from your mission and strategic objectives.
A CAPA is a formalized process which should always include a corrective action (how to immediately remediate the identified deviation), an investigation of the root cause(s), a plan to minimize the risk of the re-occurrence of the deviation based on the investigation findings, and efficacy measures to be sure that the plan will generate the expected compliance impact. All companies should have a solid Deviation Management SOP in place to dictate what triggers a CAPA and what is the process to follow.
The key point is the way CAPAs are written reveal, sometimes with brutal honesty, how the company deals with quality issues and can be extremely informative on the quality mindset prevalent in the organization. Let us review some examples.
It is always easier to blame the individuals rather than the systems
There should not be such a thing as deviations resulting from an individual’s mistake if the system is designed around quality with adequate control and reconciliation steps. If a case submission was not sent because someone forgot to click on the “send” button, the system is faulty. If you have to use weak systems such as email to send AE reports to the authorities, you should ensure that a checkpoint forces the verification that the mail was sent to the right entity and has left the outbox. A checklist is needed and its use should be documented. Human errors are rarely directly responsible of non-conformance. Only repeated errors of a same individual in spite of adequate re-training or system changes can qualify as human error. In that case, the adequate response should be to review with Human Resources what can be done to bring the individual to the expected performance. In the vast majority of the cases, the root causes are unnecessarily complex or confusing processes, inadequate training programs, lack of quality control or poor systems not supporting quality activities.
The action plan should be clear and precise, with clear owners, timelines and documentation of activities completed
As most companies use commercial systems to track their CAPAs, there can be a limitation with such systems regarding the capture of the multiple individual tasks part of the preventive actions. Each of these actions should have an owner, a precise timeline (i.e. a date) and a defined, visible and documented deliverable. All these elements should be part of the CAPA description. Not storing the information in the narrative of the CAPA itself is a mistake as it is an open door for unnecessary external tracking tools, for laziness in completing the individuals step in a timely manner, and limits QA’s ability to control that all is going well regarding the CAPA progression.
The CAPA owner should be the CAPA writer, with support and guidance from QA
The business owner closest to and most familiar with the faulty actions is the best person to lead the root cause investigation, identify preventive actions and what should be the effectiveness measurements. It is a great opportunity for increasing the knowledge on quality process and quality assurance, and reinforces the partnership with the QA function. QA should never write CAPAs for the business owner, but should instead guide and advise, being understanding and supportive like a good teacher, while avoiding being judgmental.
Like an artist, to excel in what you do, you need a great mentor, great tools and a solid technique. The final result of what you produce will be a direct reflection of these three elements. Having well designed and well executed CAPA processes will guide the organization a step further towards the ultimate goal of total quality and compliance.
The scope of what pharmacovigilance leaders must consider has greatly increased as regulatory agencies worldwide have broadened their expectations from pharmaceutical companies. The pharmacovigilance department must know about activities beyond their direct influence. Download our complementary whitepaper that addresses the challenges posed by the expectation for global oversight of the end-to-end medicinal product life cycle and proposes some fundamental steps that should be taken by pharmacovigilance leaders.
All opinions shared in this post are the author’s own.
R&D Solutions for Pharma & Life SciencesWe're happy to discuss your needs and show you how Elsevier's Solution can help.
J.-P. Clement MD
Executive Pharmacovigilance Consulting
- Why a reliable FAERS searching capability is essential for pharma companies
- Big Data and Proactive Pharmacovigilance
- The Challenges of Signal Detection in Spontaneous Reporting
- Taking a Balanced Approach to Monitoring Literature
- FDA Speeds Up Generic Approval Process