SOP for Corrective action and Preventive Action (CAPA)

This Document describes (Standard Operating procedure) SOP for Corrective Action and Preventive Action i.e. CAPA

SOP for Corrective Action and Preventive Action (CAPA)

I. Purpose & Scope:

• The purpose of this SOP for implementing of corrective and preventive action triggered through recommendation based on investigation or observation through deviation and other QMS review process to avoid occurrence or reoccurrence to eliminate the chance of potential non-conformities
• This Standard operating procedure shall be applicable for implementation of Corrective Action and Preventive Action decided after investigation from root cause of Deviations, Out of Specification, Laboratory Incident, Product Complaints, Product Recall, Returned Goods, External Audit, Internal Audit, Product Quality Review and Risk Assessment etc.

II. Responsibilities:

• All Quality Assurance personnel shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

Procedure :

• Corrective Action: Action to eliminate the cause of a detected non-conformity or other undesirable situation.
• Preventive Action: Action to eliminate the cause of a potential non-conformity or other  undesirable potential situation.

The CAPA shall be initiated as a result of following but not limited to : 

• Deviation: CAPA shall be initiated as a result of deviation.
• OOS: CAPA shall be initiated if the results found out of the specified limits mentioned in specification. e.g. Out of specification in assay result.
• External Audit: Corrective action and preventive action i.e. CAPA shall be initiated if any critical or major observations found during audit which violates GMP and written procedures.
• Annual Product Review: CAPA shall be initiated as a result of any unusual observations found during annual product review.
• Returned Goods: CAPA shall be initiated as a result of returned goods due to any non commercial reasons. e.g. Improper packing.
• Product Complaint: CAPA shall be initiated as a result of product complaint. g. Transport damage.
• Regulatory and Customer Requirement: CAPA shall be initiated as a result of non conformance to regulatory and customer requirement. e.g. Inadequate text matters printed on the product pack.
• Product Recall: CAPA shall be initiated as a result of product recall. e.g. Recall of the product due to any change in physical properties of the product.

Responsibility : 

• The Head QA is responsible to communicate all opened/closed CAPA of management review meeting to top management.
• Senior top management is responsible for providing the necessary support to ensure preventive and/or corrective actions are carried out and completed in a timely manner.

 Proposal for CAPA :

• Initiator department Head or designee and concern department shall propose corrective and preventive action with proposed target completion date to be taken against the non-conformity.
• Manager QA or designee shall verify the proposed corrective and preventive action and shall give recommendation if required.

Approval/ Rejection of proposed CAPA : 

• Head QA shall review the proposed CAPA and approve or reject the same.
• Head QA shall tick mark in the column provided for Approval or Rejection of CAPA
• In case of rejection, Head QA shall write the recommendations for effective CAPA.

Justification for extension/delay for CAPA :

• CAPA shall be closed within proposed target date of completion.
• If in case any corrective action and preventive action i.e. CAPA is not completed within the target date, initiator department Head or designee shall give the justification for extension / delay of the CAPA with next target date of completion.
• Head QA shall review the proposed justification for delay / extension of CAPA and assess the impact of CAPA extension with revised target date and approve or reject the same.
• Head QA shall tick mark in the column provided for Approval or Rejection of extension proposal.
• In case of rejection, Head QA shall write the comment.

Implementation of Corrective Action and Preventive Action : 

• CAPA Initiator department Head or designee shall implement Corrective action and Preventive action within the timeline as per action plan provided.
• corrective action and preventive action i.e. CAPA Initiator department Head or designee shall interact with cross functional team to get required input/support for implementation of corrective action and preventive action i.e. CAPA.
• CAPA Initiator department Head or designee shall verify adequacy and effectiveness of corrective action and preventive action i.e. CAPA implemented.
• CAPA Initiator department Head or designee shall record the implementation activities conducted and attach the evidence that Corrective and Preventive actions are effective.
• The documents shall then be submitted to the QA manager or designee for verification of implemented Corrective and Preventive Actions.

Verification and effectiveness check of implemented CAPA : 

• Manager or designee shall verify the effectiveness of implementation of corrective and preventive action i.e. CAPA by checking the relevant documents, system, and procedure etc. by reviewing the following, as applicable:
• All relevant SOPs, forms or other records are updated to reflect the “new” practices, as outlined in the CAPA plan.
• Training record of concerned personnel on revised or new process, system or procedures or retrained as outlined in the corrective action and preventive action i.e. CAPA plan.
• Completed batch records and forms, logbooks or other documents to verify that all revised or new procedures have been applied, as outlined in the CAPA plan.
• The changes were completed in accordance with the appropriate quality system (i.e. Change Control, Training)
• CAPA was completed in accordance to due date(s).
• A. Manager or designee shall review and closure of corrective and preventive action i.e. CAPA.
• Head QA shall review the CAPA implementation and other recommendations (if any), and shall write his or her comments and shall put his or her signature and date and shall close the same.
• If the same non-conformity re-occurs again, the preventive action need to be reviewed again the investigation has to be carried out and the investigation report has to be submitted to head QA.