Corrective And Preventative Actions (CAPA), also sometimes termed Corrective Action Plans (CAPs), are compiled from the findings of inspections and audits.
Where audits and inspections identify parts of the pharmacovigilance system that are non-functional and issues that are being encountered, CAPs will then:
Describe in detail how the company proposes to remedy each individual issue
Describe in detail the timescales and mechanisms by which this will be done
Describe in detail how those actions relate and contribute to the system as a whole
The prospect of executing corrective actions following findings of an inspection or audit can be a particularly daunting task for companies. A purely hypothetical example here could be as follows:
An Individual Case Study Report of a serious event is submitted to the regulatory authorities outside the legally required timescale, triggering an inspection. The findings of the inspection then require an adequate response from the company, in the form of a CAPA, which addresses any and all issues within the pharmacovigilance operations which have contributed to that delay. The inspection could also have identified numerous other issues of concern. Each would need to be individually addressed, with a response adequately reflecting the level of severity, formulated in sufficient detail, and using the correct terminology.
Addressing Major And/Or Critical Findings From The Pharmacovigilance System Audits
Within the European Union (EU), when the findings of a drug safety system audit bring to light major or critical findings, both the findings AND the resulting CAPA are required to be held in the Annex of the Pharmacovigilance System Master File (PSMF) for that marketing authorization until the issue has been fully resolved to the regulator’s satisfaction.
What Do CAPAs Compel Companies To Do?
CAPAs can demand anything. They are a formal response to a major or critical finding within the pharmacovigilance system. Whatever they do demand has to be:
achievable within a defined timeframe
and have assigned responsibility
They may need prior investigation with root-cause analysis before being drafted. Possible courses of action required can include:
modification or rewriting of certain Standard Operating Procedures (SOPs)
training for staff to be received in those specific new procedures
that all SOPs must be rewritten or that an entirely new set replaces them
that staff receive training in all those new procedures
However, it is also possible that within a specified timescale:
modifications to Quality Management processes are required on a large scale
a Safety Database is required to undergo important modifications
a Safety Database is required to be updated
And finally, where there have been serious systemic failures in compliance with EU drug safety laws:
the entire pharmacovigilance system may be required to be overhauled
new components may need to be added to that system
departments could need to be reorganized
in rarer cases, entire companies could need to be reorganized
Why Use PrimeVigilance For Formulating And Implementing CAPAs?
Our consultants have been extensively involved in interpreting inspection and audit findings and can pitch the response at the appropriate level. Indeed many of our consultants are former regulators and have in-depth knowledge of what regulators expect. For example, it is essential that the findings are explored appropriately to determine whether they are manifestations of underlying problems or isolated events. The response to the findings is crucial in ensuring that suitable remedies – with achievable commitments – are offered. Getting this wrong can cost companies enormous sums in activities that may be either too superficial or too intensive and wide-ranging.
The implementation of a corrective and preventive action plan can be challenging in the extreme, and expert advice and support can make the difference between a vicious cycle of repeated inspections (or worse) and a rapidly achievable compliant system that is acceptable to auditors and inspectors. To speak to one of our expert staff about how we can support you with all aspects of Corrective And Preventative Actions or Corrective Action Plans, please call in complete confidence on +44 (0)1483 307 920.
PrimeVigilance – compliant and taking the right actions