https://www.pharmasop.in The Ultimate Resource for Pharmaceutical SOPs and Best Practices Wed, 19 Jun 2024 17:23:00 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 https://www.pharmasop.in/sop-for-calibration-and-maintenance-procedures-for-calibrating-and-maintaining-equipment/ Wed, 19 Jun 2024 17:23:00 +0000 https://www.pharmasop.in/?p=1902

Calibration and Maintenance Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for calibrating and maintaining equipment to ensure accurate and reliable performance.

2) Scope

This SOP applies to all equipment used in the pharmaceutical manufacturing facility that requires calibration and maintenance.

3) Responsibilities

– Maintenance personnel are responsible for performing calibration and maintenance activities.
– QA personnel are responsible for verifying the accuracy of calibration and maintenance records.
– Department managers are responsible for ensuring that their equipment is regularly calibrated and maintained.

4) Procedure

1. Calibration Schedule
1.1. Develop a calibration schedule for all equipment requiring regular calibration.
1.2. Ensure the schedule specifies the frequency and type of calibration required.
2. Calibration Procedures
2.1. Perform calibration according to the manufacturer’s instructions and established protocols.
2.2. Use calibrated reference standards traceable to national or international standards.
2.3. Record calibration results, including any adjustments made to the equipment.
2.4. Label equipment with calibration status, date, and due date for the next calibration.
3. Maintenance Schedule
3.1. Develop a maintenance schedule for all equipment requiring regular maintenance.
3.2. Ensure the schedule specifies the frequency and type of maintenance required.
4. Maintenance Procedures
4.1. Perform maintenance according to the manufacturer’s instructions and established protocols.
4.2. Inspect equipment for wear, damage, and proper functioning.
4.3. Replace or repair any worn or damaged parts.
4.4. Record maintenance activities, including any repairs or replacements made.
5. Verification and Documentation
5.1. Verify that all calibration and maintenance activities are performed as scheduled.
5.2. Maintain calibration and maintenance records, including dates, results, and personnel involved.
5.3. Ensure records are reviewed and approved by QA personnel.
6. Handling Out-of-Tolerance Equipment
6.1. Identify and label any equipment found to be out of tolerance during calibration.
6.2. Remove out-of-tolerance equipment from service until it has been recalibrated and verified.
6.3. Document any corrective actions taken to address out-of-tolerance equipment.
7. Training
7.1. Train maintenance personnel on calibration and maintenance procedures.
7.2. Provide regular refresher training and updates on new calibration and maintenance protocols.
7.3. Document all training activities in the training log.
8. Review and Approval
8.1. Submit calibration and maintenance records to the QA department for review.
8.2. QA will review and approve the records, ensuring all activities have been performed correctly and equipment is functioning properly.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Calibration Schedule
– Calibration Record Form
– Maintenance Schedule
– Maintenance Record Form
– Training Log

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ISO 17025 – General Requirements for the Competence of Testing and Calibration Laboratories

8) SOP Version

Version 1.0

]]> https://www.pharmasop.in/sop-for-document-control-procedures-for-managing-the-creation-approval-distribution-and-archiving-of-documents/ Wed, 19 Jun 2024 15:41:00 +0000 https://www.pharmasop.in/?p=1901

Document Control Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for managing the creation, approval, distribution, and archiving of documents to ensure accurate and up-to-date documentation within the pharmaceutical manufacturing facility.

2) Scope

This SOP applies to all controlled documents within the pharmaceutical manufacturing facility, including SOPs, batch records, specifications, and quality manuals.

3) Responsibilities

– Document Control personnel are responsible for managing document control activities.
– QA personnel are responsible for reviewing and approving controlled documents.
– Department managers are responsible for ensuring that their team members comply with document control procedures.

4) Procedure

1. Document Creation
1.1. Identify the need for a new document or revision to an existing document.
1.2. Draft the document using the approved template, ensuring clarity and accuracy.
1.3. Include a unique document number, version number, and effective date.
2. Document Review and Approval
2.1. Submit the draft document to the relevant department for review.
2.2. Incorporate any feedback and make necessary revisions.
2.3. Submit the revised document to the QA department for final approval.
2.4. Obtain signatures from authorized personnel to approve the document.
3. Document Distribution
3.1. Distribute approved documents to relevant departments and personnel.
3.2. Ensure that only the most current versions of documents are in use.
3.3. Maintain a distribution log to track the dissemination of controlled documents.
4. Document Control
4.1. Store controlled documents in a secure and easily accessible location.
4.2. Implement a document control system to manage document versions and revisions.
4.3. Regularly review and update documents to ensure they remain current and relevant.
5. Document Archiving
5.1. Archive obsolete or superseded documents in a secure location.
5.2. Maintain an archive log to track archived documents and their retention periods.
5.3. Ensure that archived documents are retrievable for regulatory inspections and audits.
6. Handling Document Changes
6.1. Initiate a Document Change Request (DCR) for any revisions to controlled documents.
6.2. Follow the review and approval process for document changes.
6.3. Update the document control system to reflect the changes.
7. Training
7.1. Train all relevant personnel on document control procedures.
7.2. Provide regular refresher training and updates on any changes to document control policies.
7.3. Document all training activities in the training log.
8. Audits and Inspections
8.1. Conduct regular internal audits to ensure compliance with document control procedures.
8.2. Prepare for external audits and inspections by regulatory authorities.
8.3. Address any findings from audits and implement corrective actions as needed.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– DCR: Document Change Request

6) Documents, if any

– Document Control Template
– Document Review Log
– Distribution Log
– Archive Log
– Training Log

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ISO 9001:2015 – Quality Management Systems

8) SOP Version

Version 1.0

]]> https://www.pharmasop.in/sop-for-cleaning-and-sanitation-procedures-for-cleaning-and-sanitizing-equipment-and-facilities/ Wed, 19 Jun 2024 13:59:00 +0000 https://www.pharmasop.in/?p=1900

Cleaning and Sanitation Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for cleaning and sanitizing equipment and facilities to ensure a hygienic manufacturing environment and prevent contamination.

2) Scope

This SOP applies to all equipment and facilities within the pharmaceutical manufacturing facility that require regular cleaning and sanitation.

3) Responsibilities

– Production personnel are responsible for executing cleaning and sanitation procedures.
– QA personnel are responsible for monitoring the effectiveness of cleaning and sanitation activities.
– Maintenance personnel are responsible for ensuring that cleaning equipment and supplies are available and in good condition.

4) Procedure

1. Cleaning Schedule
1.1. Develop a cleaning schedule for all equipment and facilities, specifying the frequency and type of cleaning required.
1.2. Ensure the schedule is visible and accessible to all relevant personnel.
2. Cleaning Procedures for Equipment
2.1. Dismantle equipment as necessary to access all parts for cleaning.
2.2. Use approved cleaning agents and methods specific to each type of equipment.
2.3. Scrub and rinse equipment thoroughly to remove residues.
2.4. Inspect equipment after cleaning to ensure all residues are removed.
2.5. Reassemble equipment and document the cleaning activity in the equipment log.
3. Cleaning Procedures for Facilities
3.1. Clean floors, walls, and ceilings using appropriate cleaning agents and methods.
3.2. Focus on high-touch areas such as door handles, switches, and benches.
3.3. Dispose of waste materials in designated containers.
3.4. Document facility cleaning activities in the cleaning log.
4. Sanitation Procedures
4.1. Sanitize cleaned equipment and facilities using approved sanitizing agents.
4.2. Follow the manufacturer’s instructions for the concentration and contact time of sanitizing agents.
4.3. Ensure all surfaces are thoroughly wetted with the sanitizing solution.
4.4. Allow sanitized areas to air dry before use.
5. Verification and Monitoring
5.1. Conduct regular inspections to verify the cleanliness and sanitation of equipment and facilities.
5.2. Use microbiological swabs and tests to monitor the effectiveness of cleaning and sanitation procedures.
5.3. Document the results of inspections and tests in the monitoring log.
6. Handling Cleaning Supplies
6.1. Store cleaning agents and supplies in designated areas, away from production materials.
6.2. Label all cleaning agents with their contents and expiration dates.
6.3. Ensure cleaning equipment is cleaned and maintained after each use.
7. Training
7.1. Train all relevant personnel on proper cleaning and sanitation procedures.
7.2. Provide regular refresher training and updates on new cleaning protocols.
7.3. Document all training activities in the training log.
8. Documentation
8.1. Maintain detailed records of all cleaning and sanitation activities, including dates, times, personnel involved, and results of inspections.
8.2. Ensure all records are reviewed and approved by QA personnel.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Cleaning Schedule
– Equipment Cleaning Log
– Facility Cleaning Log
– Sanitation Monitoring Log
– Training Log

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– WHO Good Manufacturing Practices for Pharmaceutical Products

8) SOP Version

Version 1.0

]]> https://www.pharmasop.in/sop-for-change-control-procedures-for-managing-changes-to-processes-equipment-or-procedures/ Wed, 19 Jun 2024 12:17:00 +0000 https://www.pharmasop.in/?p=1899

Change Control Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for managing changes to processes, equipment, or procedures to ensure that all changes are properly evaluated, documented, and implemented without negatively impacting product quality.

2) Scope

This SOP applies to all changes affecting the manufacturing processes, equipment, procedures, or systems within the pharmaceutical manufacturing facility.

3) Responsibilities

– Department managers are responsible for initiating change control requests.
– QA personnel are responsible for evaluating, approving, and overseeing the implementation of changes.
– QC personnel are responsible for verifying that changes do not adversely affect product quality.

4) Procedure

1. Initiating Change Control
1.1. Identify the need for a change in processes, equipment, or procedures.
1.2. Complete a Change Control Request Form detailing the proposed change, its rationale, and potential impact.
1.3. Submit the completed form to the QA department for initial review.
2. Preliminary Evaluation
2.1. QA personnel conduct a preliminary evaluation of the proposed change to assess its potential impact on product quality, regulatory compliance, and business operations.
2.2. If the change is deemed significant, proceed with a formal risk assessment.
3. Risk Assessment
3.1. Conduct a risk assessment to identify potential risks associated with the proposed change.
3.2. Use appropriate risk assessment tools such as Failure Mode and Effects Analysis (FMEA) or Hazard Analysis and Critical Control Points (HACCP).
3.3. Document the findings and mitigation measures in the Risk Assessment Report.
4. Approval Process
4.1. Review the Change Control Request Form, Risk Assessment Report, and any supporting documentation.
4.2. QA personnel, along with relevant stakeholders, approve or reject the proposed change.
4.3. Document the approval decision and any conditions for implementation.
5. Implementation
5.1. Develop an implementation plan detailing the steps required to execute the change.
5.2. Communicate the approved change and implementation plan to all affected departments.
5.3. Execute the change according to the plan, ensuring minimal disruption to operations.
6. Verification and Validation
6.1. Perform verification and validation activities to ensure the change has been implemented correctly and does not adversely affect product quality.
6.2. Document the results of verification and validation activities.
7. Documentation
7.1. Update all relevant documentation, including SOPs, batch records, and equipment logs, to reflect the approved change.
7.2. Maintain a comprehensive Change Control Log to track all change control activities.
8. Review and Approval
8.1. Submit the Change Control Log and supporting documentation to the QA department for final review.
8.2. QA will review and approve the documentation, ensuring that all necessary actions have been taken and that the change has been properly managed.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– FMEA: Failure Mode and Effects Analysis
– HACCP: Hazard Analysis and Critical Control Points
– SOP: Standard Operating Procedure

6) Documents, if any

– Change Control Request Form
– Risk Assessment Report
– Change Control Log

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q10 – Pharmaceutical Quality System

8) SOP Version

Version 1.0

]]> https://www.pharmasop.in/sop-for-employee-training-procedures-for-training-employees-on-manufacturing-processes-safety-protocols-and-quality-standards/ Wed, 19 Jun 2024 10:35:00 +0000 https://www.pharmasop.in/?p=1898

Employee Training Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for training employees on manufacturing processes, safety protocols, and quality standards to ensure competence and compliance.

2) Scope

This SOP applies to all employees involved in the manufacturing, quality control, and quality assurance processes within the pharmaceutical manufacturing facility.

3) Responsibilities

– HR personnel are responsible for coordinating training programs.
– Department managers are responsible for identifying training needs and ensuring their team members receive appropriate training.
– QA personnel are responsible for providing training on quality standards and regulatory requirements.

4) Procedure

1. Training Needs Assessment
1.1. Conduct a training needs assessment for all employees based on their job roles and responsibilities.
1.2. Identify specific training requirements for new hires, existing employees, and employees transitioning to new roles.
2. Training Plan Development
2.1. Develop an annual training plan that includes mandatory training sessions, refresher courses, and any specialized training required.
2.2. Schedule training sessions and assign trainers.
3. Training Programs
3.1. Provide training on manufacturing processes, including:
3.1.1. Standard operating procedures (SOPs)
3.1.2. Equipment operation and maintenance
3.1.3. Good manufacturing practices (GMP)
3.2. Provide training on safety protocols, including:
3.2.1. Personal protective equipment (PPE) usage
3.2.2. Emergency procedures
3.2.3. Hazardous material handling
3.3. Provide training on quality standards, including:
3.3.1. Quality control procedures
3.3.2. Regulatory requirements
3.3.3. Documentation and record-keeping
4. Training Delivery
4.1. Use a variety of training methods, such as classroom sessions, on-the-job training, e-learning, and workshops.
4.2. Ensure that training materials are up-to-date and relevant to current practices and regulations.
4.3. Provide practical demonstrations and hands-on training where applicable.
5. Training Records
5.1. Maintain comprehensive training records for all employees.
5.2. Include details such as the date of training, topics covered, trainer’s name, and employee’s signature.
5.3. Update training records regularly and ensure they are easily accessible for review.
6. Training Evaluation
6.1. Evaluate the effectiveness of training programs through assessments, quizzes, and feedback from participants.
6.2. Use evaluation results to improve future training sessions.
7. Continuous Improvement
7.1. Review training programs annually to ensure they meet the evolving needs of the organization and regulatory requirements.
7.2. Incorporate feedback from employees and trainers to enhance the training process.
8. Review and Approval
8.1. Submit the annual training plan and records to the QA department for review.
8.2. QA will review and approve the training plan, ensuring it meets the required standards and compliance.

5) Abbreviations, if any

– HR: Human Resources
– QA: Quality Assurance
– GMP: Good Manufacturing Practices
– PPE: Personal Protective Equipment

6) Documents, if any

– Training Needs Assessment Form
– Annual Training Plan
– Training Attendance Record
– Training Evaluation Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q10 – Pharmaceutical Quality System

8) SOP Version

Version 1.0

]]> https://www.pharmasop.in/sop-for-auditing-suppliers-procedures-for-auditing-and-qualifying-suppliers-of-raw-materials-and-components/ Wed, 19 Jun 2024 08:53:00 +0000 https://www.pharmasop.in/?p=1897

Supplier Auditing and Qualification Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for auditing and qualifying suppliers of raw materials and components to ensure they meet specified quality standards and regulatory requirements.

2) Scope

This SOP applies to all suppliers of raw materials and components used in the pharmaceutical manufacturing facility.

3) Responsibilities

– Purchasing personnel are responsible for initiating supplier audits.
– QA personnel are responsible for conducting supplier audits and qualifying suppliers.
– QC personnel provide technical support during supplier evaluations.

4) Procedure

1. Supplier Selection
1.1. Identify potential suppliers based on business needs and product specifications.
1.2. Conduct a preliminary assessment of each supplier’s capability, quality systems, and regulatory compliance.
2. Pre-Audit Preparation
2.1. Notify the supplier of the planned audit and agree on a schedule.
2.2. Prepare an audit plan, including the audit scope, objectives, and checklist.
2.3. Gather relevant documents and records related to the supplier’s performance and previous audits, if applicable.
3. Conducting the Audit
3.1. Conduct an on-site audit of the supplier’s facilities, processes, and quality systems.
3.2. Use the audit checklist to evaluate key areas, such as:
3.2.1. Quality management system
3.2.2. Manufacturing processes
3.2.3. Quality control and testing
3.2.4. Documentation and record-keeping
3.2.5. Compliance with regulatory requirements
3.3. Document all observations, findings, and any non-conformances identified during the audit.
4. Audit Report
4.1. Prepare a detailed audit report summarizing the findings and observations.
4.2. Include an assessment of the supplier’s strengths and areas for improvement.
4.3. Assign a risk rating to the supplier based on the audit findings.
5. Supplier Qualification
5.1. Review the audit report and make a decision on supplier qualification.
5.2. If the supplier meets the required standards, qualify them as an approved supplier.
5.3. If the supplier does not meet the required standards, communicate the findings and required corrective actions to the supplier.
6. Corrective Actions and Follow-Up
6.1. If corrective actions are required, work with the supplier to develop a CAPA plan.
6.2. Monitor the implementation of corrective actions and conduct follow-up audits if necessary.
7. Documentation
7.1. Maintain all audit records, including the audit plan, checklist, audit report, and correspondence with the supplier.
7.2. Update the approved supplier list based on the audit results and qualification status.
8. Review and Approval
8.1. Submit the audit report and qualification decision to the QA department for review.
8.2. QA will review and approve the results, ensuring that all necessary actions have been taken and that the supplier meets the required standards.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Supplier Audit Plan
– Supplier Audit Checklist
– Supplier Audit Report Form
– CAPA Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q10 – Pharmaceutical Quality System

8) SOP Version

Version 1.0

]]> https://www.pharmasop.in/sop-for-environmental-monitoring-procedures-for-monitoring-and-controlling-the-manufacturing-environment/ Wed, 19 Jun 2024 07:11:00 +0000 https://www.pharmasop.in/?p=1896

Environmental Monitoring Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for monitoring and controlling the manufacturing environment to ensure it meets specified quality standards.

2) Scope

This SOP applies to all areas within the pharmaceutical manufacturing facility where environmental monitoring is required.

3) Responsibilities

– QC personnel are responsible for conducting environmental monitoring.
– Maintenance personnel are responsible for ensuring that environmental control systems are functioning properly.
– QA personnel are responsible for reviewing and approving monitoring results and ensuring compliance with regulatory standards.

4) Procedure

1. Monitoring Plan
1.1. Develop an environmental monitoring plan that includes the frequency and locations of sampling.
1.2. Define the parameters to be monitored, such as temperature, humidity, airborne particulates, and microbial contamination.
2. Sampling Methods
2.1. Use appropriate sampling methods for each parameter:
2.1.1. Temperature and humidity: Use calibrated thermohygrometers.
2.1.2. Airborne particulates: Use particle counters.
2.1.3. Microbial contamination: Use settle plates, contact plates, and air samplers.
3. Sample Collection
3.1. Collect samples according to the defined monitoring plan.
3.2. Ensure that sampling equipment is properly calibrated and maintained.
3.3. Label each sample with the date, time, location, and parameter being monitored.
4. Sample Analysis
4.1. Analyze samples in the QC laboratory using validated methods.
4.2. Record the results of the analysis, including any deviations from acceptable limits.
5. Data Recording and Trending
5.1. Record all monitoring results in the environmental monitoring log.
5.2. Perform trend analysis to identify patterns or recurring issues.
6. Deviations and Out-of-Specification Results
6.1. Investigate any deviations or out-of-specification (OOS) results immediately.
6.2. Identify the root cause of the deviation or OOS result.
6.3. Implement corrective and preventive actions (CAPA) to address the issue.
7. Review and Approval
7.1. Submit the environmental monitoring log and any deviation reports to the QA department for review.
7.2. QA will review and approve the results, ensuring that all necessary actions have been taken and that the environment meets specified quality standards.
8. Reporting
8.1. Prepare periodic reports summarizing the environmental monitoring data and trends.
8.2. Share reports with relevant departments and regulatory authorities as required.
9. Maintenance of Control Systems
9.1. Ensure that HVAC systems, HEPA filters, and other environmental control systems are regularly maintained and calibrated.
9.2. Document all maintenance activities and repairs.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– OOS: Out-of-Specification
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Environmental Monitoring Plan
– Environmental Monitoring Log
– Deviation Report Form
– CAPA Report Form

7) Reference, if any

– FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing
– ISO 14644-1:2015 – Cleanrooms and Associated Controlled Environments

8) SOP Version

Version 1.0

]]> https://www.pharmasop.in/sop-for-recall-procedures-procedures-for-recalling-defective-or-non-compliant-products-from-the-market/ Wed, 19 Jun 2024 05:29:00 +0000 https://www.pharmasop.in/?p=1895

Recall Procedures for Defective or Non-Compliant Products

1) Purpose

The purpose of this SOP is to establish a standardized procedure for recalling defective or non-compliant products from the market to ensure consumer safety and compliance with regulatory requirements.

2) Scope

This SOP applies to all products distributed by the pharmaceutical manufacturing facility.

3) Responsibilities

– QA personnel are responsible for coordinating recall activities.
– QC personnel are responsible for providing technical support and investigation.
– Distribution personnel are responsible for handling logistics and communication with customers and regulatory bodies.

4) Procedure

1. Initiating a Recall
1.1. Identify the need for a recall based on product complaints, adverse event reports, or internal quality audits.
1.2. QA personnel should convene a recall committee to assess the situation and determine the recall strategy.
2. Classification of Recall
2.1. Classify the recall based on the severity of the issue:
2.1.1. Class I: Situations where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
2.1.2. Class II: Situations where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
2.1.3. Class III: Situations where use of, or exposure to, a violative product is not likely to cause adverse health consequences.
3. Notification
3.1. Notify relevant regulatory authorities about the recall, including details of the product, nature of the defect, and the recall strategy.
3.2. Notify customers and distributors, providing instructions for returning or destroying the affected product.
4. Recall Execution
4.1. Coordinate the return of the affected product from the market, ensuring all recalled products are securely transported and stored.
4.2. Track the quantity of recalled products and document the entire process.
5. Investigation and Root Cause Analysis
5.1. Conduct a thorough investigation to identify the root cause of the defect or non-compliance.
5.2. Use appropriate root cause analysis tools, such as fishbone diagrams, 5 Whys, or failure mode and effects analysis (FMEA).
6. Corrective and Preventive Actions (CAPA)
6.1. Develop a CAPA plan to address the root cause of the recall.
6.2. Implement corrective actions to prevent recurrence of the issue.
6.3. Document all actions taken in the CAPA report.
7. Documentation
7.1. Maintain detailed records of the recall process, including notifications, returned product quantities, investigation findings, and CAPA.
7.2. Sign and date all entries in the recall records.
8. Review and Approval
8.1. Submit the completed recall records and CAPA report to the QA department for review.
8.2. QA will review and approve the results, ensuring that all necessary actions have been taken and that the recall has been properly executed.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Recall Notification Template
– Recall Log
– CAPA Report Form

7) Reference, if any

– FDA 21 CFR Part 7 – Enforcement Policy
– WHO Guidelines on Recall Procedures for Pharmaceutical Products

8) SOP Version

Version 1.0

]]> https://www.pharmasop.in/sop-for-handling-deviations-procedures-for-identifying-documenting-investigating-and-resolving-deviations-from-standard-procedures/ Wed, 19 Jun 2024 03:47:00 +0000 https://www.pharmasop.in/?p=1894

Deviation Handling Procedures

1) Purpose

The purpose of this SOP is to establish a standardized procedure for identifying, documenting, investigating, and resolving deviations from standard procedures in the pharmaceutical manufacturing process.

2) Scope

This SOP applies to all deviations from standard procedures within the pharmaceutical manufacturing facility.

3) Responsibilities

– Production and QC personnel are responsible for identifying and documenting deviations.
– QA personnel are responsible for investigating deviations, determining their impact, and ensuring appropriate corrective actions are taken.

4) Procedure

1. Identifying Deviations
1.1. Identify deviations from standard procedures during routine operations, audits, or inspections.
1.2. Examples of deviations include out-of-specification results, equipment malfunctions, and procedural errors.
2. Documenting Deviations
2.1. Document each deviation on a deviation report form.
2.2. Include details such as the nature of the deviation, date and time of occurrence, affected batch or process, and personnel involved.
2.3. Assign a unique deviation reference number for tracking purposes.
3. Initial Assessment
3.1. Conduct an initial assessment to determine the potential impact of the deviation on product quality and safety.
3.2. If the deviation has a significant impact, immediately notify the QA department and halt affected operations if necessary.
4. Investigation
4.1. QA personnel should lead a thorough investigation to determine the root cause of the deviation.
4.2. Review relevant records, conduct interviews with involved personnel, and perform any necessary tests.
4.3. Document all findings and observations during the investigation.
5. Root Cause Analysis
5.1. Identify the root cause of the deviation using appropriate analysis tools, such as fishbone diagrams, 5 Whys, or failure mode and effects analysis (FMEA).
6. Corrective and Preventive Actions (CAPA)
6.1. Develop a CAPA plan to address the root cause of the deviation.
6.2. Implement corrective actions to resolve the immediate issue.
6.3. Implement preventive actions to prevent recurrence of the deviation.
6.4. Document all actions taken in the CAPA report.
7. Documentation
7.1. Record all deviation handling activities in the deviation report form and CAPA report.
7.2. Include details of the investigation, root cause analysis, and CAPA.
7.3. Sign and date all entries in the reports.
8. Review and Approval
8.1. Submit the completed deviation report and CAPA report to the QA department for review.
8.2. QA will review and approve the results, ensuring that all necessary actions have been taken and that the deviation has been properly resolved.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Deviation Report Form
– CAPA Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q10 – Pharmaceutical Quality System

8) SOP Version

Version 1.0

]]> https://www.pharmasop.in/sop-for-handling-customer-complaints-procedures-for-logging-investigating-and-resolving-customer-complaints-related-to-capsule-quality/ Wed, 19 Jun 2024 02:05:00 +0000 https://www.pharmasop.in/?p=1893

Customer Complaint Handling Procedures

1) Purpose

The purpose of this SOP is to establish a standardized procedure for logging, investigating, and resolving customer complaints related to the quality of capsules.

2) Scope

This SOP applies to all customer complaints received by the pharmaceutical manufacturing facility.

3) Responsibilities

– Customer Service personnel are responsible for logging customer complaints.
– QC personnel are responsible for investigating complaints related to capsule quality.
– QA personnel are responsible for reviewing and approving the investigation results and ensuring appropriate corrective actions are taken.

4) Procedure

1. Logging Complaints
1.1. Record the details of the customer complaint in the customer complaint log.
1.2. Include information such as customer name, contact details, product details (e.g., batch number), nature of the complaint, and date received.
1.3. Assign a unique complaint reference number for tracking purposes.
2. Initial Assessment
2.1. Customer Service personnel should conduct an initial assessment of the complaint to determine its validity.
2.2. Forward valid complaints to the QC department for further investigation.
3. Investigation
3.1. QC personnel should conduct a thorough investigation of the complaint, including:
3.1.1. Reviewing production and quality control records for the batch in question.
3.1.2. Conducting additional testing on retained samples if necessary.
3.1.3. Interviewing relevant personnel involved in the production and quality control processes.
3.2. Document all findings and observations during the investigation.
4. Root Cause Analysis
4.1. Identify the root cause of the issue based on the investigation findings.
4.2. Use root cause analysis tools such as fishbone diagrams, 5 Whys, or failure mode and effects analysis (FMEA).
5. Corrective and Preventive Actions (CAPA)
5.1. Develop a CAPA plan to address the identified root cause.
5.2. Implement corrective actions to resolve the immediate issue.
5.3. Implement preventive actions to prevent recurrence of the issue.
5.4. Document all actions taken in the CAPA report.
6. Communication with Customer
6.1. Provide the customer with a summary of the investigation findings and actions taken.
6.2. Offer replacements, refunds, or other appropriate resolutions as necessary.
6.3. Maintain open communication with the customer until the complaint is fully resolved.
7. Documentation
7.1. Record all complaint handling activities in the customer complaint log.
7.2. Include details of the investigation, root cause analysis, CAPA, and communication with the customer.
7.3. Sign and date all entries in the log.
8. Review and Approval
8.1. Submit the completed complaint log and CAPA report to the QA department for review.
8.2. QA will review and approve the results and ensure that all necessary actions have been taken.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Customer Complaint Log
– CAPA Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ISO 10002:2018 – Quality Management – Customer Satisfaction – Guidelines for Complaints Handling in Organizations

8) SOP Version

Version 1.0

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