SOP on Corrective and Preventive Action (CAPA)
Objective : To lay down a procedure to operate as a single control point for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and / or encountered non-conformities in order to prevent their occurrence and / or recurrence.
Scope : This Standard Operating Procedure shall apply to all corrective and preventive action taken in all formulation plants.
Responsibility : HOD of concerned department shall be responsible for implementation of this procedure.
Head, Quality Assurance/ designee shall be responsible for compliance to this procedure.
Abbreviations and Definitions :
CAPA : Corrective Action and Preventive Action
Non-conformities : Non-conformities in products, manufacturing process, equipment, building and facilities with respect to predetermined acceptance criteria, specification, or cGMP elements.
Corrective Action : The action taken to eliminate the causes of an existing non-conformity, defects or other undesirable situation in order to prevent recurrence, to a degree appropriate to the magnitude of problems and adequate with the risks encountered.
Preventive Action : The action taken to eliminate the causes of a potential non-conformity, defects or other undesirable situation in order to prevent occurrence, to a degree appropriate to the magnitude of problems and adequate with the risks encountered.
Isolated Incident : Incidents not happening repeatedly.
Procedure :The concerned department shall determine action to eliminate the causes of potential non-conformities and/or encountered non-conformities in order to prevent their occurrence and/or recurrence.
The concerned department shall determine potential non-conformities and/or review encountered non-conformities arising out of procedures like Handling of Deviations in Facility, Standard Operating Procedures, Batch Manufacturing Record and Specifications; Internal Audits; Change Control; Handling of Product Complaints; Product Recall; Handling of Non-conforming In-process and Finished products; non-conforming delivery from vendors, etc. and their causes.
The concerned department along with any other relevant department, if applicable, shall determine the causes of non-conformities.
The concerned department head(s) shall evaluate the need for action to ensure that non-conformities do not occur and to prevent occurrence of potential non-conformities.
The actions required shall be determined and implemented by the concerned department.
Records of results of actions taken are to be recorded on form ‘Corrective and Preventive Action’.
Quality Assurance personnel shall allocate eleven-digit number to each CAPA form and sign with date. The number shall be in SCAPAXXX/YY format, where
S – Represents the first letter of the respective Site.
CAPA – Denotes Corrective action and Preventive action
XXX – Serial number of the CAPA i.e. 001, 002, 003, etc.
‘/’ – ‘Slash’
YY – Indicates last two digits of the year e.g. 25 for 2025, 26 for 2026. A new series of CAPA shall start at the beginning of New Year e.g. the third CAPA for the year 2025 shall have a number of GCAPA003/025 for Goa location.
The number on the form ‘Corrective and Preventive Action’ shall be given after the concerned department has proposed and/or executed the corrective and preventive action, as appropriate.
The CAPA number shall be written on corresponding recording forms (e.g. Complaint Information Form, Deviation Report, Internal Audit Report, Product Recall – Investigation & Disposition, Change Control) of procedures out of which CAPA are originating for each CAPA identified.
A logbook titled ‘Record of Corrective and Preventive Action’ shall be maintained by Quality Assurance for traceability, reviewing, trending and verification of the actions taken.