CAPA, Purpose:
CAPA, The purpose of this document is to define a systemic, standardized and effective approach to ensure that a system is in place to address quality and compliance issues and to continually improve operations by identifying any required remedial, corrective and preventive actions and implement them in a controlled fashion.
CAPA, Scope:
The process applies to quality related non-conformities or undesirable situations in XX Pharmaceuticals Ltd. (Both General & Sterile Block) from any one of the following interface processes where CAPA is required to prevent recurrence or potential occurrence of the :
[][]Critical or major deviation.
[][]Critical or major justified market complaints.
[][]Outcomes of change control procedure
[][]Internal audit
[][]Risk Management
[][]Product incidents and recall
[][]Batch rejects and reworks
[][]Periodic product reviews
[][]Stability Test Failure
[][]Out of specification results investigations.
[][]Output of monthly quality review meeting
[][]Any other investigation
[][]The process does not apply to the following as these are managed separately by individual SOPs:
[][]Minor deviation.
[][]Triggered from various gap analysis
Definitions / Abbreviation:
[][]QA: Quality Assurance
[][]SOP: Standard Operating Procedure
[][]CAPA: Corrective action and preventive action
[][]Remedial action: Action to eliminate the immediate compliance issue associated with a deviation or non conformance.
[][]Corrective action: Action to eliminate the cause of a detected non conformity or other undesirable situation & avoid reoccurrence.
[][]Preventive action: Action to eliminate the cause of a potential non conformity or any undesirable potential non conformity & avoid occurrence.
Responsibilities:
The roles and responsibility is as follows:
Head of Quality Assurance or his/her Designee
[][]Provide effective governance of the CAPA process
[][]Ensure local process are managed according to SOP
[][]Post approved CAPA in CAPA tracking system and update it
[][]Follow up and verify close-out
[][]To authorize the closure CAPA’s
Functional Head or his designee
[][]To approve and ensure implementation of the solution into routine use
CAPA owner
[][]Accountable for CAPA objective
[][]To assess possible impact on other functions
[][]Nominate CAPA leader
[][]To approve implementation of the solution into routine use.
[][]To implement the CAPA into routine use
[][]To collect data for long term monitoring of the CAPA
CAPA Team
[][]To support CAPA leader by means of their knowledge skill and experiences.
[][]To review and accept root cause and objective.
[][]To select best solution option(s) for evaluation.
[][]To select solution for implementation into routine use.
[][]Track and close out as per commitment and target date
[][]Provide physical evidence of CAPA closing
Manager, Quality Assurance
[][]Nominate CAPA Team.
[][]To select best solution option(s) for evaluation.
[][]To select solution for implementation into routine use.
[][]To approve implementation of the solution into routine use.
[][]To record and approve closure
[][]Define ongoing monitoring criteria of the Process Owner.
[][]To review and approve the root cause and objective.
[][]To assess the possible impacts on other functions
[][]Ensure that process is ‘in place’ and ‘in use’
[][]To approve implementation of the solution into routine use
[][]Approve changes to an agreed CAPA or date extension request
Procedure:
CAPA Objective
[][]After identification of a significant quality and compliance incident (triggered by any one of the interface process stated in scope) Departmental Head/CAPA Owner will prepare the [][]CAPA objective. Source of the CAPA objective may be anyone from the following:
[][]Formal investigation report according to SOP on Deviation & Investigation
[][]Audit findings and Audit report
[][]Significant risk in the Risk Register
[][]Investigation report triggered from OOS/Stability Failure/Market Complaints/Recall/ Change control
[][]Out comes from monthly quality review meetings
[][]CAPA objective constitutes the following information:
=>Current Situation/Problem to be solved
=>Actual or most probable root cause.
=>Criticality Classification (Critical/Major/Minor)
=>Time scale for resolving the issue depending on criticality.
[][]Departmental Head/CAPA owner is accountable for CAPA objective. Depending upon the criticality/priority settings in CAPA objective, CAPA owner will take the role of CAPA leader or assign a competent person as CAPA leader.
[][]The CAPA Leader will request for a reference number from the Quality Compliance. The number format will be as CAPA/YY/XXX, where YY represent for the last two digit of a year and XXX stands for the three digit sequential number derived from a CAPA register (Annexure-III) maintained by Quality Compliance personnel.
CAPA Team:
[][]Manager, Quality Assurance determines the Leader Depending upon the nature of CAPA objective and CAPA leader may form a team.
[][]For simple CAPAs one person may take the roles of Owner, CAPA leader and CAPA team.
[][]For complex CAPAs Operators, inspectors and others involved directly with the manufacture of affected product or processes should be considered for CAPA team membership.
[][]Based on the gravity, Functional Head/Department Manager will allocate resources to CAPA team.
Review & Source of CAPA :
[][]The CAPA team will review the source and all data gathered during preparation of investigation of incidence of CAPA to ensure that full understanding of the root cause.
[][]If team requires additional data they will identify and drive to collate it.
[][]Based on the risk analysis of the root cause, CAPA leader will define the criticality of the CAPA as critical, major or minor.
Determine the scope:
[][]The CAPA team will determine the possible impact of root cause on other functions/departments and record it as scope of CAPA.
[][]CAPA leader will record all the above information in the designated place of CAPA form (Annexure I)
Define and agree solution options:
[][]Determine Ideal Solution specifications
=>The CAPA team will prepare a list of criteria for an effective CAPA which will lead a robust and permanent solution to the problem. These will include any critical success factors, without which the solution will not work.
=>It may include resources required, particular people need to involve or get support from, or time constraints, cost and communication.
Develop a list of solutions
[][]The CAPA team will list all possible solution options either to eliminate the root cause permanently or to mitigate the problem where it is not possible to eliminate the root cause.
Assess the solutions
[][]The CAPA team will assess each solution option, or combination of options against ideal solution specification to determine the best solution option. At this stage the CAPA team considers practicalities such as cost effectiveness, ease of implementation, reduction of associated risk and ability to meet business needs.
Select the solution option (s)/Actions
[][]After assessment CAPA team will select the best solution option for implementation. For maximum CAPA only one selected option will meet all the criteria/requirement to eliminate/ mitigate the root cause. (At least mitigate the risk if it is not possible to eliminate the root causes).
[][]Where more than one solution options are available, select the solution which best meets the acceptance criteria.
[][]CAPA leader can escalate the issue to Monthly quality review meeting where it is not possible to define and select any solution for a CAPA objective.
Approval of proposed CAPA:
[][]Proposed CAPAs that require any trial or changes to process, ways of working, procedures or equipment, CAPA leader will raise Change Control which will be progressed through Change Control Procedure through SOP.
[][]For all major/critical CAPA, CAPA leader will consider the requirement of following at this stage:
[][]Requirements of revision/creation of any controlled documents (SOP, BMR or BPR) and associated training.
[][]Resume of operation until the CAPA is complete.
[][]CAPA leader will ensure the closing of Change Control within the defined timeframe.
[][]Then CAPA leader will submit the dully filled CAPA form (Annexure I) to Manager, Quality Assurance and Audit along with associated Change Control and validation report (if available).
[][]Manager, Quality Assurance will review and ensure that all necessary input and decision point is available in CAPA form.
[][]He/She will ensure that while developing the CAPA scope is clearly and comprehensively defined. If he/she finds any short coming CAPA will sent back for further review.
[][]After approval/authorization, QA personnel will post the CAPA in the CAPA tracking system and handover the original CAPA form to CAPA leader.
Closing of CAPA:
[][]CAPA leader will coordinate the implementation of CAPA within agreed timeframe and collect the short term monitoring data (if available).
[][]During implementation for any deviations, changes or delays to the plan, CAPA owner will raise a date extension request (Annexure II).
[][]QA Executive will ensure that an assessment of the delay has been properly conducted and will forward it to Manager, Quality Assurance.
[][]Manager, Quality Assurance will review the date extension request and the risk assessment conducted. If the justification and risk assessment appropriate, he/she will approve it and QA Executive will update the CAPA Tracking system accordingly.
[][]All date extension approvals will be formally endorsed in Monthly Quality Review Meeting.
[][]CAPA leader and CAPA owner both define the monitoring system for short and longer term monitoring of the effectiveness of the solution. Monitoring system may include any of the following (but not limited to):
=>Monthly Quality review meeting
=>Specification
[][]Duration and levels of monitoring (e.g. higher frequency initial, lower frequency longer term, extensive sampling for impacted batches etc.)
Note: For CAPA where Change Control is not required, CAPA leader and CAPA Owner directly define the monitoring criteria.
[][]After closing CAPA leader will submit the duly filled CAPA form along with closing evidences to Manager, Quality Assurance for verifying the effective closing of the CAPA. Manager, Quality Assurance will ensure that CAPA has been effectively closed.
[][]QA personnel will update the status of CAPA tracking system and post the necessary closing evidences.
[][]CAPA owner is responsible for implementing/sustaining the CAPA as routine activities.
Review of CAPA effectiveness:
[][]If requirement of long /short term monitoring data is defined as a part of monitoring system, CAPA owner will collate and communicate the monitoring data or trend to AGM, Quality Assurance for review.
[][]Executive, Quality Assurance will categorize, trend and sort the area/systems from where maximum CAPA has been triggered. He will conduct an unnoticed inspection at any time to verify the sustainable improvement of those particular systems.
Annexure:
Annexure I- Corrective and preventive action (CAPA) form
Annexure II- Date extension request
Annexure III- CAPA Issuance Log Book