Corrective and Preventive Actions (CAPA) / Corrective Action and Preventive Action are important aspects of the Pharmaceutical Industry to meet regulatory requirements. Hence, it is an essential requirement for continuous improvement. Herein we are providing complete guidance on “CAPA”.
Corrective and Preventive Actions (CAPA)
In the pharmaceutical industry, Corrective and Preventive Actions (CAPA) are a critical component of quality management systems and are often a requirement of regulatory agencies such as the FDA. CAPA helps pharmaceutical companies identify, assess, and correct quality problems in their products, processes, or systems to ensure that they meet regulatory requirements and customer expectations.
Examples of CAPA activities in the pharmaceutical industry may include:
- Investigating and resolving product quality issues such as out-of-specification results, product complaints, and non-conformances.
- Implementing process improvements to eliminate root causes of problems and ensure product quality.
- Developing and updating SOPs (Standard Operating Procedures) to ensure that processes are performed consistently and in compliance with regulatory requirements.
- Conducting risk assessments to identify potential quality problems and implementing preventive measures to mitigate these risks.
CAPA helps pharmaceutical companies maintain and improve the quality of their products and processes over time, which ultimately leads to increased customer satisfaction and improved patient outcomes.
Corrective and Preventive Actions SOP (CAPA SOP)
Standard Operating Procedure (SOP) is required to handle and implement the “Corrective and Preventive Actions”. The model SOP is provided here for guidance purposes only.
SOP Objective
To describe the procedure for ensuring Corrective action (i.e. action taken to eliminate the cause of an existing nonconformity, noncompliance, defect, or other undesirable situation in order to prevent reoccurrence.) and Preventive action (i.e. action taken to eliminate the causes of a potential nonconformity, noncompliance, defect or other undesirable situation in order to prevent occurrence) that bears an apparent potential of adverse impact on Production and Quality.
SOP Scope
This SOP is applicable for the activities which are carried out at any Pharmaceuticals Limited.
CAPA is applicable to any Non-conformance observation, Market complaints, OOS result, OOT result, Incidents, Annual Product review, Management review, Product recall, recommendations based on validation/ Qualification study, Utilities and system, Manufacturing process, Audit observation (Customer / Regulatory), Supplier issues, Risk Assessments and etc.
Corrective and Preventive Actions Procedure
A procedure that requires CAPA management as an essential element to correct/ for improvement of the existing quality system.
Corrective Actions and Preventive Actions (CAPA) Initiation
A Corrective and Preventive Actions activity shall initiate in the below-mentioned cases but not limited to.
In case of any activity which may affect the quality of the product or quality system, CAPA can be recommended by the user department and approved by QA Head/ Designee.
Consider the Source of CAPA from the below conditions.
- Incident (Lab/ General)
- Customer complaint/ Product recall
- OOS/ OOT result
- Annual Product Quality Review
- Management review
- Recommendations based on validation/ Qualification study
- Utilities and system
- Manufacturing process
- Audit observation (Internal/ Customer / Regulatory)
- Risk Assessments
Assessment of CAPA and further impact of proposed corrective and Preventive Actions shall carry-out by QA Executive/ Designee.
QA Designee shall initiate the CAPA based on the approved recommendations and record the details by generating the CAPA reference number as mentioned below.
Follow the CAPA number as CAPA/XX/YY/ZZZ.
Ex: CAPA/01/17/001
Where:
- CAPA: Corrective Action and Preventive Action
- XX: Location Code (For 01 for API Unit-X, 02 for API Unit-Y, 03 for API Unit-Z, etc.)
- YY: Last two digits of the current year
- ZZZ: Sequential Number
The above details of CAPA reference numbers and timelines shall capture in a predefined format for easy tracking.
Then, the CAPA format shall share with the respective departments for further implementation of CAPA as per the timelines.
Important Notes (CAPA management)
1) CAPA shall review by QA on a daily basis and follow up by the respective departments for timely closure.
2) In the case of multiple departments involved in the action plan, a separate tracking format can issue to the respective departments with the same CAPA reference number.
Corrective Actions and Preventive Actions (CAPA) Timelines
The initial timeline for the implementation of the CAPA shall be 45 days or based on the proposed CAPA, Head QA shall assign the timeline for the initial completion of the CAPA.
Upon receipt of the CAPA form (tracker format) by the user department, the responsible person shall progress the action plan as per the timelines.
After completion of the respective action plan, the user department HOD/ Designee shall review the CAPA and the CAPA form shall submit to QA for further verification.
QA Head/ Designee shall ensure the implementation of proposed action points as per the timelines.
Extention of Timelines
Extension of CAPA implementation: In case of delay in implementation, an extension of timelines shall be provided based on the request & justification by the user department.
The First (1st) extension of CAPA timelines can allow by QA Head/ Designee for 30 days with proper justification. In case of delay in implementation even after the first extension of CAPA, the same matter shall be escalated to the Quality Head/ Site Head.
Hence, the Second (2nd) extension of CAPA timelines shall be based on the approval from the Quality Head/ Site Head, and the timeline shall not be more than 30 days.
CAPA effectiveness and evaluation
Effectiveness monitoring shall be based on the impact of the proposed change and the monitoring program shall be decided during the CAPA initiation.
QA department shall communicate with the respective user departments for supporting documents to verify the effectiveness of CAPA.
The CAPA Effectiveness shall be evaluated as per the periodical schedule and the details are mentioned below:
A minimum of Two effectiveness monitoring programs shall be carried out for evaluation of CAPA implementation [Effectiveness monitoring can be reduced based on the degree of impactness].
First effectiveness monitoring shall be carried out within a short interval after implementation of the proposed action plan (can be selected at 30/60/90 days intervals, based on the impact).
Second effectiveness monitoring shall be carried out after the implementation of the proposed action plan (can be selected at 180/ 365 days intervals, based on the further applicability).
Refer never before Pharma articles only at PharmaeliX – OOS SOP Latest Guidance 2023
QA Head shall ensure the CAPA effectiveness
If Corrective Actions and Preventive Actions are found to be effective, a conclusion shall be drawn by the Head/ Designee QA, Status shall be updated in respective formats followed by closure.
In case of CAPA is found to be ineffective, a further action plan shall be recommended/ progressed.
Periodic review of CAPA management
The proposed CAPA and implementation status shall be evaluated half-yearly.
Previous year CAPA & implementation shall capture in the Summary of CAPA, and QA Head/ Designee shall evaluate.
Ex: June’2022 and before initiated CAPA shall be reviewed by end of July’2022, December’2022, and before initiated CAPA shall be reviewed by end of January’2023.
- During the CAPA review, repeated observation/ CAPA and ineffective CAPA shall evaluate/ investigate.
Archival/ Document Storage
During the implementation of Corrective and Preventive Actions, the CAPA format can be maintained at the user department/ QA for tracking purposes. After the closure of CAPA, the document shall be archived in the QA department.
Free Download CAPA Format | CAPA Report Template
Download the “Corrective and Preventive Actions format” provided here for easy implementation of CAPA.
CAPA Guidelines
Corrective and Preventive Actions Guidelines are available for better clarity and Guidance. Refer below link to USFDA.
CAPA examples – ATM Card
Those who are using ATM cards might be experienced the Card being disappeared from the machine. Hence, the Banks and the ATM machine vendors have taken Corrective and Preventive Actions so that the Card never goes into that.
Stay tuned here for the never before and latest Pharma articles only at harmaeliX – Quality Risk Management (QRM) Fundamentals
Corrective and Preventive Actions Frequently Asked Questions (FAQ)
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