Pharmaceutical companies deal with human and veterinary life. So, risk management and safety measures need to be prioritized and taken care of CAPA system in pharmaceutical industry holds a lot of importance to mitigate risk factors and increase safety and quality metrics.
Corrective and Prevention Action (CAPA) is a method to mitigate risks, identify existing problems, perform Root Cause Analysis (RCA), and plan and document effective solutions for future reference. CAPA plan for pharmaceutical processes holds a lot of importance in the Quality Management System (QMS) of pharma industries.
Corrective action can be defined as the necessary actions required to eradicate non-conformance and avoid repeating the same mistakes. While prevention action can be defined as the required actions implemented to prevent non-conformance as per the Root Cause Analysis Report (RCA).
CAPA Process of Pharmaceutical Industry:
Implementation of CAPA in the pharma industry is an efficient and realistic way to improve complaint handling and non-conformance. The pharmaceutical CAPA program follows the Plan Do Check Act Cycle every time to maintain its quality metrics. Root Cause Analysis (RCA) is a method that identifies sources of problems analytically and helps to come up with desirable corrections. It is an effective approach of the CAPA process. For quality management system in pharma industry, there are seven steps for CAPA, which are as follows:
- Identification – This is also the first step of root cause analysis in pharma CAPA. In this step, the corrections required for the products are identified. Along with that different sources through which the management got notified, like complaints, batch record review, audit trails, non-conformance reports, and lawsuits are identified.
- Evaluation – This step decides whether the problem requires a CAPA process or not, its severity, and the risk involved in the problem.
- Investigation – An important step for root cause analysis in pharma CAPA. This step is important for planning purposes. It finds the loopholes in Standard Operation Procedures (SOPs), and the production process of pharmaceutical industry. Documentation in pharma CAPA is done at this step by conducting audits for validation and verification.
- Analysis – This is the final and most important step of root cause analysis in pharma CAPA. Existing information is analyzed and documented. Upon analysis, missing information, complaint sources, and non-conformance reports are also investigated and documented.
- Action Plan – After proper documentation of the analysis report, necessary procedures of CAPA for pharma compliance are implemented. It can be done through training and education programs for Good Manufacturing Practices (GMP), updating Standard Operating Procedures (SOPs), or improvising quality metrics.
- Implementation – This step is the immediate effect of the action plan step. It involves designing the necessary modules designed to make the action plan successful.
- Follow-Up – This step is the final step where the final CAPA report is prepared based on the previous steps. To achieve conformance in pharma industries, continuous improvement through pharma CAPA is necessary, and for that follow-up step is mandatory.
Requirements Of Pharmaceutical CAPA:
The regulatory requirements of CAPA for pharma compliance are as follows:
- ICH Q10 – A model by the International Council for Harmonisation of technical requirements for pharmaceuticals for human use. It is designed for the Quality Management Systems (QMS) of pharmaceutical industries. It stands as the base of the Good Manufacturing Practices (GMPs) that the pharma industries follow. CAPA is one of the pharmaceutical quality metrics of ICH Q10. The ICH Q10 guidelines imply the seven-step CAPA process to deal with complaint handling and non-conformance.
- ISO 9001:2015 – International Organization for Standardization (ISO) is a developing body for making standard protocols for quality management systems in the pharma industry. ISO 9001:2015 deals with non-conformance to ensure preventive CAPA for pharma quality.
Common Challenges Of CAPA:
Facing challenges while implementing of proper Quality Management System (QMS) is very common which are:
- Inefficiency in Root Cause Analysis (RCA) leads to errors during auditing pharma CAPA processes. Identifying problems becomes an issue of great concern which leads to failure.
- Manual CAPA can lead to disasters most of the time. It leads to delays, missing critical information, and manipulations. For human error prevention in pharma CAPA, computerized tools are available which leads to the error-free implementation of CAPA in pharma industry.
- Improper or no documentation of CAPA processes during audit trials leads to massive failure in the process. No risk management in pharmaceutical CAPA processes stands in this situation.
CAPA in pharma industry is a crucial and important measure. It not only helps in dealing with non-conformance and complaint handling but focuses on the safety and efficacy of the products. The process of CAPA can be done in an organized way with CAPA quality management system (QMS) tools.
Global Pharma Tek has an expert team in clinical data management. Our team is experienced in dealing with CAPA Quality Management System (QMS) tools. We efficiently perform the Root Cause Analysis (RCA) and other pharmaceutical CAPA programs.