Enhancing Pharmaceutical Product Quality With a Comprehensive Corrective and Preventive Actions (CAPA) Framework: From Reactive to Proactive.

Autor:	Arunagiri T; Department of Pharmaceutical Quality Assurance, Sri Ramaswamy Memorial (SRM) College of Pharmacy, Sri Ramaswamy Memorial (SRM) Institute of Science and Technology, Chennai, IND., Kannaiah KP; Department of Pharmaceutical Quality Assurance, Sri Ramaswamy Memorial (SRM) College of Pharmacy, Sri Ramaswamy Memorial (SRM) Institute of Science and Technology, Chennai, IND., Vasanthan M; Department of Pharmaceutical Quality Assurance, Sri Ramaswamy Memorial (SRM) College of Pharmacy, Sri Ramaswamy Memorial (SRM) Institute of Science and Technology, Chennai, IND.
Jazyk:	angličtina
Zdroj:	Cureus [Cureus] 2024 Sep 19; Vol. 16 (9), pp. e69762. Date of Electronic Publication: 2024 Sep 19 (Print Publication: 2024).
DOI:	10.7759/cureus.69762
Abstrakt:	Corrective and preventive actions (CAPA) are crucial components of quality assurance (QA) within the pharmaceutical industry, essential for maintaining product quality, safety, and regulatory compliance. The review explores the multifaceted role of CAPA in pharmaceutical manufacturing, emphasizing its structured approach to detecting, addressing, and preventing quality issues. CAPA systems are integral to the broader quality management system (QMS), functioning as a dual-loop mechanism that is reactive and proactive approach aligned with continuous improvement principles outlined by the International Organization for Standardization (ISO) 9001:2000. It details the three distinct phases of CAPA: correction or remedial action, corrective action (CA), and preventive action (PA). It highlights the importance of root cause analysis and the necessity for immediate corrections and long-term preventive measures to avoid recurring issues. Regulatory expectations, such as those from the Food and Drug Administration (FDA) under the Code of Federal Regulations (CFR) title 21 part 820 and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q10, are discussed, underscoring the need for a comprehensive CAPA plan that integrates data analysis and ongoing process enhancements. Additionally, the paper introduces the 8D methodology as a structured problem-solving approach to complement CAPA efforts. By providing an in-depth examination of CAPA procedures and their implementation, this article aims to contribute to the understanding and effectiveness of quality systems in pharmaceutical manufacturing. Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. (Copyright © 2024, Arunagiri et al.)
Databáze:	MEDLINE
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