Standard Operating Procedure for Implementing Corrective and Preventive Actions (CAPA)

1) Purpose

This SOP outlines the procedures for identifying, implementing, and monitoring corrective and preventive actions (CAPA) to ensure the continuous improvement of GMP processes and compliance.

2) Scope

This SOP applies to all personnel responsible for identifying deviations, non-conformances, and other issues requiring CAPA at [Company Name].

3) Responsibilities

• Department Supervisors: Identify issues requiring CAPA and ensure that corrective actions are implemented.
• Quality Assurance (QA): Monitors the effectiveness of CAPA and ensures compliance with GMP standards.

4) Procedure

4.1 Identifying Issues Requiring CAPA

4.1.1 Sources of CAPA

• CAPA may be required as a result of internal audits, deviations, non-conformances, complaints, or process failures. Any identified issues should be documented in the CAPA log.

4.1.2 CAPA Investigation

• Perform a root cause analysis for each identified issue to determine the underlying cause. Use tools such as Fishbone Diagrams, 5-Why Analysis, or Failure Mode and Effect Analysis (FMEA).

4.2 Implementing Corrective Actions

4.2.1 Developing Corrective Actions

• Based on the root cause analysis, develop corrective actions to address the issue. Corrective actions should be specific, measurable, achievable, relevant, and time-bound (SMART).
• Document the proposed corrective actions in the CAPA log and submit them for QA approval.

4.2.2 Implementing Corrective Actions

• Department supervisors must implement corrective actions according to the proposed timeline. Document the completion of corrective actions in the CAPA log and submit for QA review.

4.3 Implementing Preventive Actions

4.3.1 Identifying Preventive Measures

• Review processes to identify potential risks or failures that could lead to non-conformance. Implement preventive measures to mitigate these risks before issues occur.

4.3.2 Monitoring Preventive Actions

• Document all preventive actions in the CAPA log and monitor their effectiveness over time. Ensure that preventive measures are integrated into relevant SOPs and processes.

4.4 Post-CAPA Activities

4.4.1 Monitoring CAPA Effectiveness

• QA will conduct follow-up audits to verify the effectiveness of corrective and preventive actions. Document the results of follow-up audits in the CAPA log.

4.4.2 Documentation

• All CAPA-related activities, including root cause analysis, corrective actions, preventive actions, and follow-up audits, must be documented in the CAPA log and retained for regulatory audits.

5) Abbreviations, if any

• CAPA: Corrective and Preventive Action
• QA: Quality Assurance

6) Documents, if any

• CAPA Log

7) References, if any

• Internal SOP for root cause analysis

8) SOP Version

Version 1.0

Annexure

1. CAPA Log Template

  

    
Date
    
Issue Identified
    
Root Cause
    
Corrective Action
    
Preventive Action
    
Due Date
    
QA Approval
  
  

    
DD/MM/YYYY
    
Description of Issue
    
Root Cause Analysis
    
Corrective Action Taken
    
Preventive Action Implemented
    
Deadline for Completion
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

1) Purpose

This SOP outlines the procedures for conducting internal GMP audits and implementing corrective actions to ensure compliance with Good Manufacturing Practices and regulatory requirements.

2) Scope

This SOP applies to all departments and personnel involved in GMP-regulated activities at [Company Name].

3) Responsibilities

• Internal Audit Team: Conducts scheduled GMP audits of production, quality control, and documentation activities.
• Department Supervisors: Ensure that their respective areas are prepared for audits and that corrective actions are implemented as required.
• Quality Assurance (QA): Reviews audit findings and verifies the effectiveness of corrective actions.

4) Procedure

4.1 Planning the Audit

4.1.1 Developing the Audit Schedule

• Develop an annual audit schedule, with at least one internal GMP audit conducted per department per year. Prioritize critical areas based on risk assessments and past audit findings.
• Distribute the audit schedule to department heads and ensure that adequate resources are allocated for the audit process.

4.1.2 Preparing for the Audit

• Audit teams must prepare an audit checklist specific to the area being audited. The checklist should include key areas such as production processes, quality control, documentation, and personnel training.
• Ensure that all relevant SOPs, batch records, and logs are available for review during the audit.

4.2 Conducting the Audit

4.2.1 Performing the Audit

• During the audit, review all processes, records, and practices to ensure compliance with GMP standards. Inspect production areas, equipment, and documentation for adherence to procedures.
• Interview personnel to assess their understanding of GMP principles and their roles in ensuring compliance. Document all observations and findings in the audit report.

4.2.2 Identifying Non-Conformances

• If any non-conformances are identified during the audit, document them in the audit report and classify them based on their severity (e.g., minor, major, critical).
• Discuss findings with the department supervisor and ensure that corrective actions are proposed to address the non-conformances.

4.3 Post-Audit Activities

4.3.1 Preparing the Audit Report

• Compile all audit findings and corrective actions into an audit report. Include a summary of the areas audited, non-conformances identified, corrective actions required, and timelines for implementation.
• Submit the audit report to QA for review and approval.

4.3.2 Implementing Corrective Actions

• Department supervisors must implement corrective actions within the specified timeline and document the completion of these actions in the corrective action log.
• QA will verify the effectiveness of the corrective actions through follow-up audits or inspections.

5) Abbreviations, if any

• GMP: Good Manufacturing Practices
• QA: Quality Assurance

6) Documents, if any

• Audit Report
• Corrective Action Log

7) References, if any

• Internal SOP for corrective actions

8) SOP Version

Version 1.0

Annexure

1. Audit Report Template

Standard Operating Procedure for Emergency Preparedness and Response

1) Purpose

This SOP outlines the procedures for responding to emergencies, including fire, chemical spills, and equipment failures, in GMP-regulated facilities. The goal is to ensure safety and minimize the impact on production.

2) Scope

This SOP applies to all personnel working in GMP-regulated areas at [Company Name].

3) Responsibilities

• Employees: Report emergencies immediately and follow the emergency response protocols.
• Supervisors: Lead the emergency response and ensure the safety of all personnel.
• Quality Assurance (QA): Document all incidents and ensure compliance with regulatory reporting requirements.

4) Procedure

4.1 Emergency Preparedness

4.1.1 Emergency Drills

• Conduct regular emergency drills, including fire evacuation, chemical spill response, and equipment failure scenarios. Ensure all personnel participate in drills at least once per year.
• Document the results of each drill, including the response time and areas for improvement, in the emergency preparedness log.

4.1.2 Emergency Equipment

• Ensure that all emergency equipment, including fire extinguishers, spill kits, and first aid supplies, is accessible and in good working order. Inspect emergency equipment monthly and document the inspection in the equipment log.

4.2 Emergency Response Procedures

4.2.1 Fire Response

• In the event of a fire, activate the nearest fire alarm and evacuate the building immediately. Follow the designated evacuation routes and assemble at the designated meeting point.
• Only trained personnel should attempt to use fire extinguishers to contain small fires.

4.2.2 Chemical Spill Response

• For minor chemical spills, use the spill kit to contain and clean up the spill. Dispose of contaminated materials as per the hazardous waste disposal SOP.
• For major spills, evacuate the area and contact the EHS (Environmental, Health, and Safety) team for assistance. Document all spills in the incident log.

4.2.3 Equipment Failure

• If critical production equipment fails, stop production immediately and notify the supervisor. Record the equipment failure in the maintenance log and submit for QA review.
• Do not resume production until the equipment has been repaired and approved for use by QA.

4.3 Post-Emergency Activities

4.3.1 Incident Reporting

• Document all emergency incidents, including fires, spills, and equipment failures, in the incident log. Provide a detailed description of the event, the response, and any corrective actions taken.
• Submit the incident report to QA and EHS for review and follow-up.

4.3.2 Corrective Actions

• Following any emergency incident, implement corrective actions to prevent recurrence. Review the incident during the next safety meeting and update SOPs as needed.

5) Abbreviations, if any

• QA: Quality Assurance
• EHS: Environmental, Health, and Safety

6) Documents, if any

• Emergency Preparedness Log
• Incident Log
• Equipment Log

7) References, if any

• Internal SOP for hazardous waste disposal
• Internal SOP for fire safety

8) SOP Version

Version 1.0

Annexure

1. Incident Log Template

  

    
Date
    
Incident Type
    
Location
    
Description
    
Response Actions
    
QA Approval
  
  

    
DD/MM/YYYY
    
Fire/Chemical Spill/Equipment Failure
    
Room/Facility
    
Detailed Description
    
Response Taken
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preventing Cross-Contamination in Production

1) Purpose

This SOP outlines the procedures for preventing cross-contamination in GMP-regulated production areas, ensuring product safety and compliance with GMP standards.

2) Scope

This SOP applies to all personnel working in production areas at [Company Name].

3) Responsibilities

• Operators: Follow protocols to prevent cross-contamination during production activities.
• Supervisors: Monitor compliance with cross-contamination prevention measures.
• Quality Assurance (QA): Regularly review production areas to ensure adherence to cross-contamination prevention measures.

4) Procedure

4.1 Segregation of Production Areas

4.1.1 Dedicated Production Zones

• Maintain dedicated areas for the production of different products or dosage forms. Ensure that production lines are physically separated to avoid cross-contamination.
• Label all production areas clearly, indicating the product being manufactured.

4.1.2 Airflow and Ventilation

• Ensure that the HVAC system is properly maintained and that airflow is directed from clean areas to less clean areas to prevent airborne contamination. Use HEPA filters where necessary.
• Document any changes in airflow patterns and report deviations in the environmental control log.

4.2 Personnel Hygiene and Gowning

4.2.1 Gowning Procedures

• All personnel must wear the appropriate protective garments, including gloves, hairnets, and shoe covers, when entering production areas. Change garments between shifts and before entering areas where different products are being manufactured.
• Gowning areas must be equipped with clean garments, and personnel must follow SOP for gowning to prevent contamination.

4.2.2 Hand Hygiene

• All personnel must wash hands thoroughly with soap and water and use hand sanitizers before entering production areas. Perform hand hygiene before and after handling materials.

4.3 Equipment Cleaning and Maintenance

4.3.1 Cleaning Between Batches

• Clean all production equipment thoroughly between product batches to prevent contamination. Follow cleaning procedures outlined in the cleaning SOP and document all cleaning activities in the cleaning log.
• Conduct visual inspections of equipment after cleaning to ensure that no residues remain. Report any deviations to the supervisor.

4.3.2 Maintenance of Equipment

• Perform routine maintenance of all production equipment as per the maintenance schedule. Document maintenance activities in the equipment maintenance log.
• Ensure that any damaged equipment is repaired or replaced immediately to prevent contamination risks.

4.4 Material Handling

4.4.1 Segregation of Materials

• Segregate raw materials, intermediates, and finished products to prevent cross-contamination. Store materials in clearly labeled containers and ensure that storage areas are segregated by product type.
• Maintain separate storage areas for hazardous materials, active ingredients, and excipients.

4.4.2 Material Transfer

• Follow approved transfer protocols when moving materials between different production areas. Use dedicated equipment for specific materials, and document all material transfers in the batch manufacturing record (BMR).

4.5 Post-Operation Activities

4.5.1 Documentation

• Record all activities related to cross-contamination prevention, including cleaning, maintenance, and material handling, in the appropriate logs (e.g., cleaning log, maintenance log).
• Submit all documentation to QA for review and approval before starting a new batch.

5) Abbreviations, if any

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• HEPA: High-Efficiency Particulate Air

6) Documents, if any

• Cleaning Log
• Maintenance Log
• Environmental Control Log

7) References, if any

• Internal SOP for cleaning and maintenance

8) SOP Version

Version 1.0

Annexure

1. Cross-Contamination Prevention Log Template

  

    
Date
    
Area
    
Activity Performed
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Production Area
    
Cleaning/Inspection/Material Transfer
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Supplier Qualification and Quality Audits

1) Purpose

This SOP defines the process for qualifying suppliers and conducting regular quality audits to ensure that materials meet GMP requirements and product quality standards.

2) Scope

This SOP applies to all personnel involved in the evaluation, qualification, and auditing of suppliers at [Company Name].

3) Responsibilities

• Purchasing Department: Identify and evaluate potential suppliers based on quality standards.
• Quality Assurance (QA): Conduct supplier audits and review supplier documentation to ensure compliance with GMP regulations.

4) Procedure

4.1 Supplier Qualification Process

4.1.1 Supplier Evaluation

• Identify potential suppliers and evaluate their ability to provide materials that meet GMP standards. Evaluate suppliers based on their quality management systems, regulatory compliance, and history of supply performance.

4.1.2 Documentation Review

• Review documentation from the supplier, including Certificates of Analysis (COAs), product specifications, and GMP certifications. Document all reviews in the supplier qualification log.

4.1.3 Supplier Approval

• Approve suppliers that meet GMP standards and product specifications. Document the approval in the supplier qualification log and maintain records for auditing purposes.

4.2 Supplier Quality Audits

4.2.1 Audit Planning

• QA will develop an annual audit schedule based on the criticality of the supplier and the materials supplied. Plan audits for key suppliers at least once per year.

4.2.2 Conducting the Audit

• Conduct on-site audits or remote documentation audits to evaluate the supplier’s GMP compliance. Use a standard audit checklist to assess the supplier’s quality systems, documentation, and production processes.

4.2.3 Audit Findings and Corrective Actions

• Document any findings during the audit and communicate them to the supplier. Suppliers must submit corrective action plans for any deficiencies identified during the audit.
• Record all findings and corrective actions in the audit report. Submit the report for QA review and approval.

4.3 Post-Audit Activities

4.3.1 Ongoing Supplier Monitoring

• QA will continue to monitor supplier performance, reviewing incoming materials for compliance with specifications. Any issues must be documented and addressed with the supplier immediately.

4.3.2 Documentation

• Document all supplier qualifications, audit findings, and corrective actions in the supplier qualification log. Maintain records for at least five years.

5) Abbreviations, if any

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• COA: Certificate of Analysis

6) Documents, if any

• Supplier Qualification Log
• Audit Report

7) References, if any

• Internal SOP for supplier audits

8) SOP Version

Version 1.0

Annexure

1. Supplier Qualification Log Template

  

    
Date
    
Supplier Name
    
Materials Supplied
    
GMP Compliance Status
    
QA Approval
  
  

    
DD/MM/YYYY
    
Supplier Name
    
Materials Description
    
Compliance Status
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Temperature and Humidity Monitoring in Production Areas

1) Purpose

This SOP outlines the procedures for monitoring and controlling temperature and humidity levels in GMP production areas to ensure product quality and compliance with regulatory standards.

2) Scope

This SOP applies to all personnel involved in the monitoring and recording of temperature and humidity levels in controlled areas at [Company Name].

3) Responsibilities

• Operators: Record temperature and humidity levels at specified intervals and report any deviations.
• Maintenance Team: Ensure HVAC systems are functioning properly and within the specified parameters.
• Quality Assurance (QA): Review environmental logs and investigate any deviations from set parameters.

4) Procedure

4.1 Monitoring Equipment

4.1.1 Calibration of Monitoring Devices

• Ensure that all temperature and humidity monitoring devices are calibrated regularly to ensure accuracy. Record all calibrations in the calibration log.

4.1.2 Placement of Monitoring Devices

• Place temperature and humidity sensors in critical areas of the production facility. Ensure sensors are not obstructed and are placed away from heat sources, doors, and windows.

4.2 Recording and Reporting

4.2.1 Temperature and Humidity Readings

• Record temperature and humidity levels at least twice per shift (e.g., every four hours) or as required by production standards. Ensure readings are within the specified range for the product being manufactured.
• If any deviation occurs, report it immediately to the supervisor and document it in the environmental control log.

4.2.2 Response to Deviations

• In the event of temperature or humidity deviations, stop production immediately, and investigate the cause. Make adjustments to HVAC systems if necessary and document corrective actions.
• Record deviations in the deviation log and submit for QA review.

4.3 Post-Monitoring Activities

4.3.1 Documentation

• Record all temperature and humidity readings in the environmental control log. Ensure the log is reviewed by QA at the end of each shift.

4.3.2 Maintenance of HVAC Systems

• Perform routine maintenance of HVAC systems to ensure optimal performance. Document any repairs or maintenance in the equipment log and submit for QA review.

5) Abbreviations, if any

• HVAC: Heating, Ventilation, and Air Conditioning
• QA: Quality Assurance

6) Documents, if any

• Environmental Control Log
• Calibration Log
• Deviation Log

7) References, if any

• Internal SOP for HVAC maintenance

8) SOP Version

Version 1.0

Annexure

1. Temperature and Humidity Monitoring Log Template

  

    
Date
    
Room ID
    
Temperature (°C)
    
Humidity (%)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Room Identifier
    
Temperature Measured
    
Humidity Measured
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Routine Maintenance of GMP Equipment and Facilities

1) Purpose

This SOP provides guidelines for the routine maintenance of GMP equipment and facilities to ensure optimal performance, prevent contamination, and maintain compliance with GMP standards.

2) Scope

This SOP applies to all personnel involved in the maintenance of equipment and facilities at [Company Name].

3) Responsibilities

• Operators: Perform routine maintenance and document all activities in the maintenance log.
• Maintenance Team: Responsible for overseeing equipment maintenance schedules and performing corrective actions.
• Quality Assurance (QA): Reviews maintenance logs and ensures that all equipment is functioning within GMP standards.

4) Procedure

4.1 Routine Maintenance Schedule

4.1.1 Daily Maintenance

• Inspect all equipment at the start and end of each production shift. Check for any wear or damage that may affect performance or safety. Document inspections in the equipment log.
• Perform basic cleaning and lubrication of moving parts, following the manufacturer’s guidelines. Record all activities in the maintenance log.

4.1.2 Weekly Maintenance

• Conduct a detailed inspection of all critical equipment, including motors, belts, filters, and seals. Replace any worn components and document the replacements in the maintenance log.
• Calibrate equipment as per the calibration schedule to ensure accuracy. Record all calibrations in the calibration log and submit for QA approval.

4.1.3 Monthly Maintenance

• Perform a full-system check of all GMP equipment, including HVAC systems, temperature controls, and cleanroom facilities. Address any identified issues promptly and document the maintenance in the log.

4.2 Post-Maintenance Activities

4.2.1 Cleaning and Documentation

• After performing maintenance, clean all tools, equipment, and areas involved in the process. Ensure that no debris or contaminants remain in the production environment.
• Document all maintenance activities, including inspections, repairs, calibrations, and cleaning, in the maintenance log. Submit records to QA for review.

4.2.2 QA Review and Equipment Approval

• QA must review and approve all maintenance logs before equipment is returned to service. Any deviations from the maintenance schedule must be documented in the deviation log.

5) Abbreviations, if any

• GMP: Good Manufacturing Practices
• QA: Quality Assurance

6) Documents, if any

• Maintenance Log
• Calibration Log
• Deviation Log

7) References, if any

• Manufacturer’s equipment manual
• Internal SOP for equipment calibration

8) SOP Version

Version 1.0

Annexure

1. Maintenance Log Template

  

    
Date
    
Equipment ID
    
Maintenance Performed
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Equipment Name
    
Maintenance Description
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Waste Management and Disposal in GMP Facilities

1) Purpose

This SOP outlines the procedures for the management and disposal of waste generated in GMP-regulated production areas. Proper waste management is critical for preventing contamination and ensuring compliance with environmental regulations.

2) Scope

This SOP applies to all personnel involved in waste handling and disposal at [Company Name].

3) Responsibilities

• Operators: Ensure proper segregation of waste and disposal in designated areas.
• Supervisors: Monitor waste disposal activities and ensure compliance with waste management procedures.
• Environmental, Health, and Safety (EHS) Team: Ensure compliance with local regulations for waste disposal and manage waste disposal contractors.

4) Procedure

4.1 Waste Segregation

4.1.1 Waste Categories

• Waste generated in GMP areas must be segregated into the following categories:
  • Hazardous waste
  • Non-hazardous waste
  • Biological waste
  • Recyclable waste

4.1.2 Proper Labeling

• Label all waste containers clearly, specifying the type of waste and any relevant handling instructions. Ensure labels are visible and legible at all times.
• For hazardous waste, include hazard symbols and any necessary precautions on the labels.

4.2 Waste Disposal Procedures

4.2.1 Hazardous Waste Disposal

• Dispose of hazardous waste following the guidelines provided in the Safety Data Sheet (SDS) for each chemical. Coordinate with certified waste disposal contractors for hazardous waste removal.
• Document all hazardous waste disposals in the waste management log, including the type of waste, quantity, and disposal method.

4.2.2 Non-Hazardous Waste Disposal

• Dispose of non-hazardous waste in designated containers and ensure it is removed regularly. Non-hazardous waste may include packaging materials, paper, and general waste from GMP areas.

4.2.3 Biological Waste Disposal

• Dispose of biological waste following regulatory guidelines. This includes biological samples, used gloves, or any contaminated equipment. Use biohazard bags and ensure that waste is autoclaved before disposal.

4.3 Post-Operation Activities

4.3.1 Waste Management Documentation

• Record all waste disposal activities, including the type of waste, quantity, and disposal method, in the waste management log. Ensure all entries are reviewed by the EHS team and QA.

4.3.2 Compliance Monitoring

• The EHS team will perform regular audits to ensure compliance with waste management regulations. Any deviations from the SOP must be documented in the deviation log and corrective actions implemented.

5) Abbreviations, if any

• GMP: Good Manufacturing Practices
• EHS: Environmental, Health, and Safety

6) Documents, if any

• Waste Management Log
• Deviation Log

7) References, if any

• Local environmental regulations
• Internal SOP for hazardous waste disposal

8) SOP Version

Version 1.0

Annexure

1. Waste Management Log Template

  

    
Date
    
Waste Type
    
Quantity (kg/L)
    
Disposal Method
    
Operator Initials
    
Supervisor Approval
  
  

    
DD/MM/YYYY
    
Type of Waste
    
Quantity Disposed
    
Disposal Method
    
Operator Name
    
Supervisor Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Employee Training and Competency Development

1) Purpose

This SOP outlines the procedures for training and competency development for employees working in GMP-regulated areas. Proper training ensures that employees are knowledgeable about GMP requirements, their roles, and responsibilities.

2) Scope

This SOP applies to all employees working in GMP-regulated production and quality control areas at [Company Name].

3) Responsibilities

• Training Manager: Responsible for organizing and scheduling employee training programs.
• Supervisors: Ensure employees have completed required training before performing their roles and assess employee competency periodically.
• Quality Assurance (QA): Verifies that training records are accurate and compliant with GMP regulations.

4) Procedure

4.1 Training Program Setup

4.1.1 Identifying Training Needs

• Conduct a needs assessment to identify required training for all roles in GMP areas, including new hires and existing staff. Ensure that training covers relevant SOPs, GMP principles, safety protocols, and job-specific tasks.

4.1.2 Scheduling Training

• Develop a training schedule that covers both initial and ongoing training sessions. All new hires must complete initial training before they begin working in GMP areas.
• Ensure ongoing GMP and role-specific training sessions are conducted at least once every six months.

4.2 Conducting Training Sessions

4.2.1 Training Content

• Training sessions should cover:
  • GMP principles and regulatory requirements.
  • Personal hygiene and cleanroom entry/exit procedures.
  • Handling of hazardous chemicals and safety protocols.
  • Job-specific tasks and procedures, including SOP compliance.
• Provide training materials, such as handouts, videos, and practical demonstrations to reinforce learning.

4.2.2 Competency Assessment

• Assess employee competency through written tests, practical demonstrations, and on-the-job evaluations. Employees must demonstrate competency in their roles before being authorized to work independently in GMP areas.
• Document all assessments and retain records in the employee training log.

4.3 Post-Training Activities

4.3.1 Recordkeeping

• Document the completion of all training sessions and competency assessments in the employee training log. Include the employee’s name, training date, topics covered, and the trainer’s initials.
• Submit training records to QA for review and retention as per GMP documentation requirements.

4.3.2 Training Feedback and Improvement

• Collect feedback from employees on the effectiveness of the training program. Use the feedback to identify areas for improvement in future training sessions.
• QA and supervisors must review training feedback and incorporate necessary changes to the training program.

5) Abbreviations, if any

• GMP: Good Manufacturing Practices
• QA: Quality Assurance

6) Documents, if any

• Employee Training Log
• Competency Assessment Form

7) References, if any

• Internal SOP for employee development and training

8) SOP Version

Version 1.0

Annexure

1. Employee Training Log Template

  

    
Employee Name
    
Employee ID
    
Training Date
    
Training Topics
    
Trainer Initials
    
QA Approval
  
  

    
Employee Name
    
Employee ID
    
DD/MM/YYYY
    
Topics Covered
    
Trainer Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Pest Control and Management in GMP Areas

1) Purpose

This SOP outlines the procedures for pest control and management in GMP areas to ensure a clean and contamination-free manufacturing environment.

2) Scope

This SOP applies to all personnel responsible for pest control in GMP areas at [Company Name].

3) Responsibilities

• Pest Control Operators: Perform regular inspections and implement pest control measures.
• Maintenance Team: Ensure that building integrity is maintained to prevent pest entry.
• Quality Assurance (QA): Review pest control logs and ensure compliance with regulatory standards.

4) Procedure

4.1 Pest Control Measures

4.1.1 Regular Inspections

• Inspect GMP areas for signs of pests at least once per week, including storage areas, loading docks, and production facilities. Use traps and monitoring devices to detect infestations.
• Document the results of the inspections in the pest control log.

4.1.2 Pest Prevention Measures

• Ensure that all entry points, including doors and windows, are sealed properly to prevent pest entry. Install mesh screens where necessary.
• Maintain a clean environment by regularly disposing of waste and ensuring proper storage of raw materials.

4.1.3 Pest Control Applications

• If pests are detected, use approved pest control chemicals or traps according to the product’s label instructions. Only certified personnel may apply pest control measures.
• Ensure that all pest control applications are documented in the pest control log, including the date, type of pest control used, and location.

4.2 Post-Operation Activities

4.2.1 Reporting and Documentation

• Record all pest control measures, inspections, and actions taken in the pest control log. Submit documentation to QA for review weekly.
• If a pest infestation is found, supervisors must notify QA immediately and implement corrective actions to prevent further contamination.

4.2.2 Maintenance of Pest Control Equipment

• Ensure that pest control traps, monitoring devices, and equipment are maintained and cleaned regularly. Replace any worn-out traps or damaged equipment as needed.
• Document the maintenance of pest control equipment in the equipment maintenance log.

5) Abbreviations, if any

• GMP: Good Manufacturing Practices
• QA: Quality Assurance

6) Documents, if any

• Pest Control Log
• Equipment Maintenance Log

7) References, if any

• Internal SOP for pest control

8) SOP Version

Version 1.0

Annexure

1. Pest Control Log Template

  

    
Date
    
Area Inspected
    
Pest Type (if detected)
    
Action Taken
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Room/Facility Inspected
    
Type of Pest Detected
    
Control Measures Taken
    
Operator Name
    
QA Name