The purpose of regulatory authorities is to oversee the operations of entities in industries within particular jurisdictions. The oversight role is crucial because it helps to ensure agencies observe set protocols for the certainty of maintaining the desired levels of product quality and safe working spaces for employees. Ostensibly, problems may hardly be alleviated in entirety, as there are always unseen challenges and mishaps. A tool identified as the “corrective action, preventive action” (CAPA) is often used to ensure problems do not recur once identified and corrected for the first time. This report is a detailed CAPA plan for Diwali Pharmaceuticals, which is a Hawaii-based hypothetical company. In essence, this CAPA plan is informed by a recent FDA status as-is report, which indicated that the firm failed to conduct critical investigations needed for the implementation of corrective and preventive actions against batch failures.
The FDA report requires immediate action to avoid the imposition of restrictive actions against Diwali Pharmaceuticals. As such, the decision to adopt the CAPA tool will ensure that the problem is resolved through a structured approach for the certainty of finding a lasting solution. Rodríguez-Pérez (2016) asserts that the CAPA tool provides the structure needed to review the root cause of first-time problems, solve the challenges, document underlying conditions, and recommend preventive measures to avoid recurrence. Ostensibly, the Food and Drug Administration (FDA) recommends the use of the CAPA approach among companies in the food processing, medical device manufacturing, and pharmaceutical industries as the basis of corrective action whenever underlying problems are highlighted.
Identification/Overview of the Problem
The first step to an effective CAPA plan is problem identification and definition. Raj (2016) posits that a workable solution can only be established if the details of the problem or challenge are known, which requires a thorough review of available evidence of an underlying problem. Information about an underlying issue may come from various sources, such as quality audits, customer complaints, service requests, quality assurance inspections, and trend data. For the current hypothetical case study, a recent FDA report indicated that batch failures due to inadequate investigations have increased in a near-exponential manner in the pharmaceutical industry (Deshpande et al., 2020). The regulatory body has since issued a note requiring the company to initiate CAPA processes in a bid to ensure improved quality of all products entering the market. However, further inquiry is needed to have a clear glimpse of the underlying causes, which leads to the investigations component of this plan.
Investigations to determine the facts about the problem highlighted in the report are highly recommended. In essence, this CAPA step is largely a form of research to establish whether a factual problem exists. Pramod et al. (2016) assert that investigations are necessary because they unearth problems that might not have been captured in assessment reports. Particularly, an evaluation of the reasons why highlighted issues are important to warrant some action is critical. Regarding the Diwali Pharmaceuticals case, the investigations must be centered on the number of customer complaints about defective products. The management might have to establish a team to examine the current inventory for the possibilities of faulty batches. Based on the findings from the survey, it will be possible to determine the need for further inquiry or action, which should pave the way for the subsequent steps of the CAPA process.
Analytical Review of the Root Cause
Further inquiry may indicate that the FDA report was misleading if Diwali Pharmaceuticals was among exempted firms with negligible batch failure cases. In that case, the company would only need to maintain its quality assurance systems. However, if the study on existing inventory and the prevalence of customer complaints show proof of an underlying problem, a detailed root-cause analysis would be paramount. Tashi et al. (2016) assert that the success of the CAPA process largely depends on the ability to conduct a thorough root-cause analysis. Critical aspects of focus in this stage include the review of internal processes, such as loopholes in the product testing procedures. Common sources of errors, such as employee negligence and recurrent system failure, must be considered in every review of possible underlying causes (Venkatesh & Puranik, 2018). In the current case, the action and preventive plan will depend on all causes of the problems highlighted in the FDA report.
The team responsible for the CAPA process must recommend and oversee the implementation of corrective and preventive actions. Essentially, the essence of CAPA is to devise strategies to offset identified problems and set strategies to avoid or minimize the chances of reoccurrence. Nevertheless, the action plan must involve the verification and validation of corrective and preventive measures within the organization, and the message passed to concerned regulatory bodies (Rodríguez-Pérez, 2016). Haleem et al. (2015) assert that documenting all activities is critical for effective resolution and handling of product quality problems, which is a basic step to prevention from recurrence. In the case of Diwali Pharmaceuticals, the management will work closely with internal and external assessors and strategists to institute an effective approach to the batch failure problem. A management review panel will then review the action plan activities to determine their viability. The following implementation and follow-up activities are recommended based on the findings from the root-cause analysis.
Deshpande, P., Agawane, R., Tatikola, S. C., & Vasantharaju, S. G. (2020). US FDA warning letters of CAPA violations: A review. Applied Clinical Research, Clinical Trials, and Regulatory Affairs, 7(2), 85-92. Web.
Haleem, R. M., Salem, M. Y., Fatahallah, F. A., & Abdelfattah, L. E. (2015). Quality in the pharmaceutical industry: A literature review. Saudi Pharmaceutical Journal, 23(5), 463-469. Web.
Pramod, K., Tahir, M. A., Charoo, N. A., Ansari, S. H., & Ali, J. (2016). Pharmaceutical product development: A quality by design approach. International Journal of Pharmaceutical Investigation, 6(3), 129-130. Web.
Raj, A. (2016). A review of corrective action and preventive action (CAPA). African Journal of Pharmacy and Pharmacology, 10(1), 1-6. Web.
Rodríguez-Pérez, J. (2016). Handbook of investigation and effective CAPA systems. Quality Press.
Tashi, T., Mbuya, V. B., & Gangadharappa, H. V. (2016). Corrective action and preventive actions and its importance in the quality management system: A review. International Journal of Pharmaceutical Quality Assurance, 7(01), 1-6. Web.
Venkatesh, C., & Puranik, S. B. (2018). Importance of self–inspection in the pharmaceutical industry as per various regulatory guidelines. Biomedical and Pharmacology Journal, 11(1), 387-391. Web.