Corrective and Preventive actions (CAPA)

1.0 OBJECTIVE

To lay down a procedure for Corrective and Preventive actions for Non Conformances occurred during the manufacturing Process.

2.0 SCOPE

This procedure is applicable to all the drug products manufactured at XXX, Place

3.0 RESPONSIBILITY

3.1 Initiation and Closure: Head of any department

3.2 Review: Head-Quality Assurance

4.0 PROCEDURE

4.1 Corrective Action

4.1.1 Action taken to rectify, fix or correct a specific deviation, defect or undesirable situation.

4.2 Preventive action

4.2.1 Action taken to eliminate the cause of deviation, defect, or other undesirable situation in order to prevent the future occurrence of such or similar an event.

4.3 CAPA procedure involves the following steps

4.3.1 Identification of the problem

4.3.1.1 The initial step in the process is to clearly define the problem. This shall include source of the problem, detailed explanation of the problem and available evidence that the problem exists.

4.3.1.2 Source of the problem

4.3.1.2.1 The source of the problem may be one of the following

4.3.1.2.1.1 GMP Investigations

4.3.1.2.1.2 Deviations

4.3.1.2.1.3 Change control

4.3.1.2.1.4 Laboratory (OOS) Investigations

4.3.1.2.1.5 Internal Audit Reports

4.3.1.2.1.6 External / Customer Audits

4.3.1.2.1.7 Annual Product Reviews

4.3.1.2.1.8 Regulatory Inspection Reports

4.3.1.2.1.9 Management Action Plans

4.3.1.2.1.10 Changes in regulatory / Pharmacopoeia requirements

4.3.1.2.1.11 Product Failures

4.3.1.2.1.12 Complaints

4.3.1.2.1.13 Product recall

4.3.1.2.1.14 Returned Goods

4.3.1.2.1.15 Incidence Report

4.3.1.2.1.16 Installation reports

4.3.1.2.1.17 Tending data

4.3.1.2.1.18 Other sources are possible and will depending on the circumstances.

4.3.1.3 Description of the problem

4.3.1.3.1 The complete description of the problem shall have sufficient information to assure that the problem can be easily understood.

4.3.1.4 Evidence to the problem

4.3.1.4.1 List the specific information available that demonstrate that the problem does exist.

4.3.2 Evaluation

4.3.2.1 Evaluate the problem identified in the ‘Identification’ section and identify the need for action and then the level of action required. The potential impact of the problem and the actual risks to the company and/ or customers must be determined.

4.3.2.1.1 Potential impact

4.3.2.1.1.1 Determine the potential impact of the problem to the product quality, safety, and efficacy and customer satisfaction.

4.3.2.1.2 Assessment of Risk

4.3.2.1.2.1 Based on the determination of the potential impact, the seriousness of the problem is assessed. The level of risk that is associated with the problem may affect the actions that are taken. The risk classification shall be as follows i.e High priority, medium and low priority.

4.3.2.1.2.2 The problem that presents a serious risk to the quality or safety may be assigned a high priority and require immediate remedial action.

4.3.2.1.2.3 When the label is wrongly coded repeatedly may have a low priority.

4.3.2.1.3 Remedial action

4.3.2.1.3.1 Based on the outcome of the potential impact and assessment of the risk, determine the remedial action shall be taken immediately until a thorough investigation and permanent solution shall implemented.

4.3.2.1.3.2 If the remedial actions are necessary, the actions and the resources required are listed. The steps that must be taken immediately to avoid any further adverse effects are explained.

4.3.3 Investigation

4.3.3.1 Conduct the investigation into the problem identified in the above steps. The investigation procedure should include an objective for the actions that will be taken, the procedure to be followed, the personnel that will be responsible and any anticipated resources needed

4.3.3.2 Objective

4.3.3.2.1 The first step in the investigation is to state an objective for the action.

4.3.3.2.2 The objective shall be desired outcome of the corrective and preventive action.

4.3.3.3 Investigation procedure

4.3.3.3.1 The procedure shall consist of set of instructions to determine the contributing and root cause of the problem.

4.3.3.3.2 While writing the instructions for investigating procedure considers equipment, personnel, procedures, design, training and external factors.

4.3.3.3.3 The procedure shall incorporate a comprehensive review and analysis of all circumstances related to the problem.

4.3.3.4 Responsibilities/ Resource

4.3.3.4.1 Assign responsibilities for conducting each aspect of the investigation. Any additional resources that may be required is also identified and documented.

4.3.4 Analysis

4.3.4.1 The investigation procedure that was created is now used to investigate the cause of the problem.

4.3.4.2 The primary goal of the analysis is to determine the root cause of the problem described, but any contributing causes are also identified.

4.3.4.3 The process involves collecting relevant data, investigating all possible causes, and using the information available to determine the cause of the problems.

4.3.4.3.1 Possible Causes or Data collection

4.3.4.3.1.1 A list of possible causes shall be created. This will form the basis for collecting relevant information, test data etc.

4.3.4.3.1.2 By considering all possible causes, appropriate information and data can be collected that will ultimately be used to determine the root cause of the problem.

4.3.4.3.2 Results and Data

4.3.4.3.2.1 The results of the data collection shall be documented and organized. The data may include and not limited to combination of testing results and/ or review records, processes, design, operations etc. that may lead to a determination of the fundamental cause of the problem.

4.3.4.3.2.2 The resulting documentation shall be complete and address the possible causes that were previously determined. This information is used to determine the root cause of the problem.

4.3.4.3.3 Root Cause analysis

4.3.4.3.3.1 Determine the root cause by following the fish bone diagram. Identify the possible causes and draw the effect of those causes.

4.3.4.3.3.2 Document the root cause of the problem and this will be essential for determining the appropriate corrective and/ or preventive actions that must be taken.

4.3.5 Action plan

4.3.5.1 By using the results from the above analysis, the optimum method for correcting the problem shall be determined and action plan shall be developed. The plan shall consists of items to be completed, document changes, any process, procedure, or system changes required, employee training, and any process controls necessary to prevent the problem or a reoccurrence of the problem.

4.3.5.1.1 Actions to be completed

4.3.5.1.1.1 List all the activities and tasks that shall be accomplished to either correct the existing problem or eliminate a potential problem

4.3.5.1.2 Document or specification changes

4.3.5.1.2.1 List any documents that shall be modified and describe in general terms what the modifications will be.

4.3.5.1.3 Process, procedure, or system changes

4.3.5.1.3.1 If any changes to process, procedures, or systems shall be made they are described. Enough detail shall be included to understand what must be done. Explain the expected outcome of these changes.

4.3.5.1.4 Employee training

4.3.5.1.4.1 Employee training is an essential part of any change that is made and should be part of the action plan. To assure that the actions taken will be effectively communicated to all the persons or departments that will be effected.

4.3.6 Implementation

4.3.6.1 The corrective / preventive action plan that has been created shall be implemented. All of the required tasks listed and described in the action plan are initiated, completed and documented.

4.3.6.1.1 Implementation summary

4.3.6.1.1.1 All the activities that have been completed as required in the action plan shall be listed and summarized. This section contains a complete record of the actions that shall be taken to correct the problem and assures that it will not occur. This includes preventive measures, process controls, training etc

4.3.6.1.2 Documentation

4.3.6.1.2.1 All the documents or other specifications that have been modified shall be listed. The documents shall be attached to a final printed report of CAPA. This will facilitate verification of the changes for the follow up.

4.3.7 Follow up

4.3.7.1 The follow-up actions must be effectively monitored to checks that the CAPA is effectively implemented.

4.3.7.1.1 Verification of results

4.3.7.1.1.1 The implementation and completion of all changes, controls, training etc. must be verified. The evidence that this has been done shall be recorded. Information shall be entered to document that all actions have been completed successfully.

4.3.7.1.2 Results/ effectiveness of the actions

4.3.7.1.2.1 Another important aspect of any CAPA action is to make sure that the actions taken were effective. A thorough evaluation shall be done to make sure that the root cause of the problem has been solved, that any resulting secondary situation have been corrected, the proper controls have been established, and that adequate monitoring of the situation is in place.

4.4 Initiation and closure of CAPA:

4.4.1 The initiation of CAPA requires submission of source of the problem by concerned Department Head to QA.

4.4.2 Department Head shall decide the need for CAPA with Head QA.

4.4.3 The Department Head shall get a CAPA form issued from QA. QA shall write the source of the problem on the form before issue of form (Annexure-1).

4.4.4 Department Head shall fill the CAPA form as under.

4.4.4.1 Date CAPA initiated

4.4.4.2 Write the department initiating the CAPA.

4.4.4.3 Write the detailed description of the problem.

4.4.4.4 Write the evidence observed and preliminary assessment of potential impact and/risk.

4.4.4.5 The Department Head shall write their name with signature and date.

4.4.5 The department head shall send the CAPA form to QA.

4.4.6 Head-QA / Designee shall allot a reference number to the CAPA form and make relevant entries in the CAPA register (Annexure-2). Forward the CAPA form to the concerned department.

4.4.7 The CAPA shall be numbered serially in the calendar year for each department with an identification code of department. A typical CAPA form shall be numbered IIII/CAPA/ XX /000 / 00

Where,

IIII indicates Company name

CAPA indicates Corrective and Preventive action

XX indicates Department Code

YYY indicates Serial Number (Starts from 001 to 999)

YY indicates last two digits of the Year

4.5 Then, evaluate the problem listed in the Annexure-1 by the concerned department head and Quality Assurance head along with others departmental heads, if necessary.

4.6 Based on the outcome of the evaluation, if immediate remedial actions are necessary, shall be identified, performed and documented through Annexure-3.

4.7 Based on the problem identified and investigation into the problem shall be initiated through Annexure-4. The investigation procedure shall consist of objective, investigation procedure, resources or responsibilities.

4.8 Investigation procedure determines the root cause of the problem and also other contributing causes of the problem are also identified.

4.9 The data generated during the investigation shall be analyzed. The analysis process involves List of possible causes and supporting data, Analysis Results and Data, Supporting Documents attached Root Cause determination, Supporting documents attached and analysis completion date. The analysis of the problem shall be done through Annexure-5.

4.10 Based on the analysis of the problem, action plan shall be deduced and record the Actions to be completed, Document Changes required, Procedure, process, or system changes required, Training required, Action plan assigned to, Expected completion date and Approved by (Sign and Date) through Annexure-6.

4.11 The action plan implementation and follow up shall be conducted by filling the Annexure-7 after writing the Actions completed, Document Changes Done, Procedure, process, or system changes done, Training given to, Verification done by, CAPA Closure date and finally signature and date by Head-QA.

5.0 ABBREVIATIONS

5.1 QA: Quality Assurance

5.2 GMP: Good Manufacturing Practice

5.3 CAPA: Corrective and Preventive actions

5.4 MD: Managing Director

5.5 SOP: Standard Operating Procedure

6.0 ANNEXURE

6.1 Annexure-1: Corrective / Preventive Action Request

6.2 Annexure-2: Corrective And Preventive Actions Register

6.3 Annexure-3: Remedial Action Required

6.4 Annexure-4: Investigation Procedure

6.5 Annexure-5: Problem Analysis