Key Terms Used in CAPA Management

1. Corrective action

A systematic process undertaken to identify, analyze, and eliminate the root cause of a nonconformity or deviation in order to prevent its recurrence.

2. Preventive action

Proactive measures taken to identify and eliminate potential causes of nonconformities or deviations before they occur.

3. Nonconformity

Any deviation from established standards, procedures, or specifications that may affect the quality, safety, or efficacy of a pharmaceutical product.

4. Deviation

An unexpected or unplanned event that occurs during the manufacturing, testing, packaging, or distribution of a pharmaceutical product and may impact its quality, safety, or efficacy.

5. Root cause analysis

A systematic approach used to identify the underlying cause(s) of a nonconformity or deviation by examining contributing factors and their interactions.

6. Corrective action plan

A documented strategy outlining the steps to be taken to address and resolve a nonconformity or deviation identified through investigation and analysis.

7. Preventive action plan

A documented strategy outlining proactive measures to be implemented in order to prevent the occurrence of potential nonconformities or deviations.

8. Risk assessment

The process of evaluating the likelihood and potential impact of identified risks on product quality, safety, or efficacy in order to prioritize corrective and preventive actions.

9. CAPA (Corrective and Preventive Actions) system

A formalized system within an organization that manages the identification, investigation, resolution, and prevention of nonconformities and deviations.

10. Quality management system (QMS)

A set of policies, processes, procedures, and resources implemented by an organization to ensure consistent quality in its products or services throughout all stages of their lifecycle.

11. Change control

A formalized process for evaluating proposed changes to systems, processes, equipment, materials, etc., in order to assess their potential impact on product quality and ensure appropriate corrective and preventive actions are taken.

12. Continuous improvement

The ongoing effort to enhance processes, systems, and products through the identification and implementation of corrective and preventive actions based on data analysis, feedback, and lessons learned.

13. Validation

The documented evidence that a process, system, or equipment consistently produces results meeting predetermined specifications and quality requirements.

14. Verification

The process of evaluating whether a product, system, or component meets specified requirements or standards.

15. Compliance

Adherence to applicable laws, regulations, guidelines, and standards governing the pharmaceutical industry to ensure the safety, efficacy, and quality of products.

Read also: Corrective and Preventive Action (CAPA) in Pharmaceutical Industry

Resource Person: Ershad Moradi

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