Standard Operating Procedure for Internal Audits

1) Purpose

The purpose of this SOP is to establish procedures for planning, conducting, and reporting internal audits to verify compliance with regulatory requirements, quality standards, and organizational policies within the organization.

2) Scope

This SOP applies to all departments and functions within the organization responsible for conducting internal audits.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Internal Audit Manager:

Responsible for overseeing the internal audit program and conducting audits as per schedule.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving audit plans, reports, and corrective actions.

3.3 Department Managers/Supervisors:

Responsible for supporting internal audits within their respective departments and implementing corrective actions.

4) Procedure

4.1 Audit Planning:

4.1.1 Establish an Internal Audit Schedule based on organizational priorities and regulatory requirements.
4.1.2 Define audit scope, objectives, and criteria for each audit.
4.1.3 Identify audit team members and allocate resources for audit preparation.

4.2 Audit Execution:

4.2.1 Conduct entrance meetings with auditees to explain audit objectives, scope, and expectations.
4.2.2 Review documentation and records to assess compliance with applicable standards and procedures.
4.2.3 Perform interviews and observations to gather audit evidence.

4.3 Audit Reporting:

4.3.1 Prepare an Audit Report summarizing findings, observations, and non-conformities identified.
4.3.2 Include recommendations for corrective actions and improvements based on audit findings.
4.3.3 Obtain auditee feedback on draft Audit Report before finalizing and distributing.

4.4 Corrective Action and Follow-Up:

4.4.1 Assign corrective actions to address audit findings and non-conformities.
4.4.2 Monitor implementation of corrective actions and verify effectiveness.
4.4.3 Close audit findings upon completion of corrective actions and verification.

4.5 Audit Records and Documentation:

4.5.1 Maintain audit records, including Audit Reports, corrective action plans, and verification records.
4.5.2 Archive audit documentation in accordance with document retention policies.
4.5.3 Use audit findings for management review and continuous improvement initiatives.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Internal Audit Schedule
2. Audit Plan Template
3. Audit Report Template
4. Corrective Action Plan Form

7) Reference, if any

1. ISO 19011:2018 Guidelines for auditing management systems
2. FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0

Standard Operating Procedure for Calibration of Equipment

1) Purpose

The purpose of this SOP is to establish procedures for the calibration, maintenance, and verification of equipment to ensure accuracy, reliability, and compliance with regulatory requirements within the organization.

2) Scope

This SOP applies to all departments and personnel responsible for the calibration and maintenance of equipment used in production, testing, and quality control activities.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Calibration Manager:

Responsible for overseeing the calibration program and ensuring compliance with calibration procedures.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving calibration procedures and records.

3.3 Equipment Users:

Responsible for notifying the Calibration Manager of equipment requiring calibration and maintenance.

4) Procedure

4.1 Equipment Identification:

4.1.1 Identify equipment requiring calibration based on established calibration schedules.
4.1.2 Label equipment with unique identification numbers and calibration due dates.
4.1.3 Maintain an Equipment Calibration Schedule to track calibration activities.

4.2 Calibration Standards and Procedures:

4.2.1 Establish calibration standards and procedures for each type of equipment.
4.2.2 Ensure calibration procedures are based on manufacturer recommendations and regulatory requirements.
4.2.3 Document calibration procedures in the Equipment Calibration Manual.

4.3 Calibration Execution:

4.3.1 Perform calibration activities by trained personnel following approved procedures.
4.3.2 Use calibrated standards and equipment traceable to national or international standards.
4.3.3 Record calibration results, including deviations and adjustments made during calibration.

4.4 Calibration Records and Documentation:

4.4.1 Maintain accurate and up-to-date calibration records for each equipment.
4.4.2 Document calibration certificates, adjustment records, and calibration due dates.
4.4.3 Secure calibration records in a controlled environment accessible only to authorized personnel.

4.5 Equipment Maintenance and Verification:

4.5.1 Perform preventive maintenance on equipment as per manufacturer recommendations.
4.5.2 Verify equipment performance periodically through calibration checks and tests.
4.5.3 Address non-conformities or deviations identified during equipment verification.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Equipment Calibration Schedule
2. Equipment Calibration Manual
3. Calibration Certificates
4. Maintenance Records

7) Reference, if any

1. ISO 9001:2015 Quality management systems – Requirements
2. FDA Guidance for Industry: Calibration of Equipment Used in GMP Environment

8) SOP Version

Version 1.0

Standard Operating Procedure for Product Complaint Handling

1) Purpose

The purpose of this SOP is to establish procedures for the receipt, evaluation, investigation, and resolution of product complaints to ensure customer satisfaction, regulatory compliance, and continuous improvement.

2) Scope

This SOP applies to all departments and personnel within the organization responsible for receiving, documenting, and resolving product complaints.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Complaints Manager:

Responsible for overseeing the product complaint handling process and ensuring timely resolution.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving complaint investigations and corrective actions.

3.3 Customer Service Representatives:

Responsible for receiving and documenting product complaints from customers.

4) Procedure

4.1 Complaint Receipt and Registration:

4.1.1 Receive product complaints from customers through designated channels (e.g., phone, email, web portal).
4.1.2 Record complaint details including customer information, nature of complaint, and product identification.
4.1.3 Assign a unique complaint number and enter details into the Complaint Log.

4.2 Complaint Evaluation and Classification:

4.2.1 Evaluate the complaint to determine validity, seriousness, and impact on product quality or safety.
4.2.2 Classify complaints based on severity and regulatory implications (e.g., adverse events, recalls).
4.2.3 Notify QA and relevant departments of critical complaints requiring immediate action.

4.3 Complaint Investigation:

4.3.1 Form an investigation team including QA, Regulatory Affairs, and Production personnel.
4.3.2 Conduct a thorough investigation to determine root cause(s) of the complaint.
4.3.3 Document investigation findings, including root cause analysis and impact assessment.

4.4 Corrective and Preventive Actions (CAPA):

4.4.1 Develop and implement corrective actions addressing root causes identified during investigation.
4.4.2 Propose preventive actions to prevent recurrence of similar complaints.
4.4.3 Obtain QA approval of CAPA plans and monitor implementation effectiveness.

4.5 Resolution and Follow-Up:

4.5.1 Communicate resolution of the complaint to the customer within defined timelines.
4.5.2 Document customer feedback or acceptance of resolution.
4.5.3 Follow up with customers as necessary to ensure satisfaction and closure of complaint.

4.6 Trend Analysis and Reporting:

4.6.1 Analyze product complaint trends to identify recurring issues or emerging patterns.
4.6.2 Prepare periodic reports on complaint trends, investigation outcomes, and corrective actions.
4.6.3 Present findings to management for review and decision-making on process improvements.

5) Abbreviations, if any

QA – Quality Assurance
CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Complaint Log
2. Investigation Reports
3. CAPA Plans and Reports
4. Customer Communication Records

7) Reference, if any

1. FDA Guidance for Industry: Handling and Reporting of Product Quality Complaints
2. ISO 13485 Medical devices – Quality management systems

8) SOP Version

Version 1.0

Standard Operating Procedure for Non-Conformance Management

1) Purpose

The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of non-conformances to prevent recurrence and ensure continuous improvement within the organization.

2) Scope

This SOP applies to all departments and processes within the organization that may encounter non-conformances impacting product quality, safety, or regulatory compliance.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Non-Conformance Coordinator:

Responsible for overseeing the non-conformance management process and ensuring timely resolution.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving non-conformance investigations and corrective actions.

3.3 Department Managers/Supervisors:

Responsible for initiating non-conformance reports and implementing corrective actions.

4) Procedure

4.1 Non-Conformance Identification:

4.1.1 Identify and document instances of non-conformance from established processes or procedures.
4.1.2 Classify non-conformances based on severity and impact on product quality or safety.
4.1.3 Assign a unique non-conformance number and enter details into the Non-Conformance Log.

4.2 Non-Conformance Investigation:

4.2.1 Form an investigation team including relevant stakeholders (e.g., QA, Production).
4.2.2 Conduct a root cause analysis to determine factors contributing to the non-conformance.
4.2.3 Document investigation findings, including root cause(s) and impact assessment.

4.3 Impact Assessment:

4.3.1 Evaluate the impact of the non-conformance on product quality, safety, and regulatory compliance.
4.3.2 Determine immediate corrective actions to prevent further non-conformances.
4.3.3 Notify QA and relevant departments of the non-conformance assessment.

4.4 Corrective and Preventive Actions (CAPA):

4.4.1 Develop and implement corrective actions addressing root causes of the non-conformance.
4.4.2 Propose preventive actions to prevent recurrence of similar non-conformances.
4.4.3 Obtain QA approval of CAPA plans and monitor implementation effectiveness.

4.5 Non-Conformance Closure and Documentation:

4.5.1 Verify completion and effectiveness of implemented corrective actions.
4.5.2 Close non-conformance report and document final disposition and approval.
4.5.3 Archive non-conformance records and maintain for regulatory inspections and audits.

5) Abbreviations, if any

QA – Quality Assurance
CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Non-Conformance Log
2. Investigation Reports
3. CAPA Plans
4. Non-Conformance Closure Records

7) Reference, if any

1. FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
2. ICH Q10 Pharmaceutical Quality System

8) SOP Version

Version 1.0

Standard Operating Procedure for Training Records and Documentation

1) Purpose

The purpose of this SOP is to establish procedures for the creation, maintenance, and control of training records and documentation to ensure personnel are adequately trained and qualified to perform their assigned responsibilities.

2) Scope

This SOP applies to all departments and personnel within the organization responsible for conducting and documenting training activities.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Training Manager:

Responsible for overseeing the training program and ensuring compliance with training requirements.

3.2 Department Supervisors/Managers:

Responsible for identifying training needs and ensuring personnel complete required training.

3.3 Quality Assurance (QA) Specialist:

Responsible for maintaining training records and conducting periodic reviews of training effectiveness.

4) Procedure

4.1 Training Needs Assessment:

4.1.1 Identify training needs based on job responsibilities, changes in procedures, or regulatory requirements.
4.1.2 Document training requirements for each position or role within the organization.
4.1.3 Prioritize training based on criticality and impact on operations.

4.2 Training Plan Development:

4.2.1 Develop a training plan outlining objectives, content, and methods for delivering training.
4.2.2 Obtain approval of the training plan from department supervisors and management.
4.2.3 Allocate resources and schedule training sessions based on the training plan.

4.3 Training Execution:

4.3.1 Conduct training sessions using approved training materials and resources.
4.3.2 Document attendance and participation of trainees in each training session.
4.3.3 Assess trainee understanding and competency through evaluations or assessments.

4.4 Training Records Management:

4.4.1 Maintain accurate and up-to-date training records for all personnel.
4.4.2 Document training completion, assessment results, and any qualifications or certifications obtained.
4.4.3 Secure training records in a controlled environment accessible only to authorized personnel.

4.5 Training Evaluation and Continuous Improvement:

4.5.1 Evaluate training effectiveness through feedback from trainees and supervisors.
4.5.2 Identify opportunities for improving training content, delivery methods, or assessment tools.
4.5.3 Update training materials and procedures based on evaluation findings and feedback.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Training Needs Assessment Form
2. Training Plan Template
3. Training Attendance Records
4. Training Evaluation Forms
5. Training Effectiveness Reports

7) Reference, if any

1. ISO 9001:2015 Quality management systems – Requirements
2. FDA Guidance for Industry: Training Programs for Employees in GMP Environment

8) SOP Version

Version 1.0

Standard Operating Procedure for Document Control

1) Purpose

The purpose of this SOP is to establish procedures for the control, distribution, revision, and archiving of documents to ensure accuracy, accessibility, and compliance with regulatory requirements within the organization.

2) Scope

This SOP applies to all departments and functions within the organization that create, review, approve, distribute, and maintain documents as part of the quality management system.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Document Control Manager:

Responsible for overseeing the document control system and procedures.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving controlled documents and managing document changes.

3.3 Department Heads:

Responsible for ensuring departmental compliance with document control procedures and requirements.

4) Procedure

4.1 Document Creation and Approval:

4.1.1 Create documents using approved templates and formats.
4.1.2 Obtain necessary approvals (e.g., author, reviewer, approver) as per document control procedures.
4.1.3 Assign a unique document number and version control for identification.

4.2 Document Distribution:

4.2.1 Distribute approved documents to relevant departments or individuals.
4.2.2 Ensure controlled copies are accessible only to authorized personnel.
4.2.3 Maintain a distribution log to track document dissemination.

4.3 Document Revision and Change Control:

4.3.1 Initiate document changes through the Change Request Form.
4.3.2 Review and approve document changes by designated personnel.
4.3.3 Update document version and notify affected parties of changes.

4.4 Document Retrieval and Archiving:

4.4.1 Establish document retrieval procedures to ensure timely access to current documents.
4.4.2 Archive obsolete or superseded documents in accordance with document retention policies.
4.4.3 Maintain document archives and ensure availability for regulatory inspections and audits.

4.5 Document Control Review and Improvement:

4.5.1 Conduct periodic reviews of document control procedures and effectiveness.
4.5.2 Implement improvements to document control processes based on review findings and feedback.
4.5.3 Provide training to personnel on updated document control procedures as necessary.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Document Control Procedures Manual
2. Document Templates
3. Change Request Form
4. Distribution Log
5. Document Archive Inventory

7) Reference, if any

1. ISO 9001:2015 Quality management systems – Requirements
2. FDA Guidance for Industry: Document Control

8) SOP Version

Version 1.0

Standard Operating Procedure for Supplier Qualification and Management

1) Purpose

The purpose of this SOP is to establish procedures for the qualification, selection, evaluation, and management of suppliers to ensure a consistent supply of materials and services that meet quality and regulatory requirements.

2) Scope

This SOP applies to all departments and functions within the organization responsible for supplier management, including procurement, quality assurance, and production.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Procurement Manager:

Responsible for establishing and maintaining the supplier qualification program.

3.2 Quality Assurance (QA) Specialist:

Responsible for approving supplier qualification and monitoring supplier performance.

3.3 Production Manager:

Responsible for ensuring that only qualified suppliers are used for materials and services.

4) Procedure

4.1 Supplier Qualification:

4.1.1 Identify potential suppliers based on business needs and requirements.
4.1.2 Evaluate supplier capabilities, quality systems, and regulatory compliance.
4.1.3 Conduct supplier audits or assessments as necessary to verify capabilities.

4.2 Supplier Selection and Approval:

4.2.1 Select suppliers based on evaluation criteria including quality, reliability, and cost.
4.2.2 Obtain necessary documentation (e.g., certificates, quality agreements) from selected suppliers.
4.2.3 Approve suppliers for use based on evaluation results and regulatory requirements.

4.3 Supplier Performance Monitoring:

4.3.1 Monitor supplier performance through metrics such as on-time delivery and quality of materials.
4.3.2 Conduct periodic reviews or audits of supplier performance and compliance.
4.3.3 Address non-conformities or issues with suppliers through corrective actions.

4.4 Supplier Relationship Management:

4.4.1 Maintain regular communication with suppliers to ensure alignment on quality expectations.
4.4.2 Manage supplier relationships to foster collaboration and continuous improvement.
4.4.3 Update supplier records and qualifications as necessary based on performance reviews.

4.5 Supplier Change Control:

4.5.1 Evaluate and approve changes to supplier arrangements or specifications.
4.5.2 Document changes and communicate them to relevant departments.
4.5.3 Update supplier qualification records and documentation accordingly.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Supplier Qualification Checklist
2. Supplier Evaluation Reports
3. Supplier Audit Reports
4. Supplier Performance Metrics

7) Reference, if any

1. ISO 9001:2015 Quality management systems – Requirements
2. FDA Guidance for Industry: Supplier Evaluation and Control

8) SOP Version

Version 1.0

Standard Operating Procedure for Change Management

1) Purpose

The purpose of this SOP is to establish procedures for the management of changes to facilities, equipment, materials, processes, and documentation to ensure controlled and effective change management within the manufacturing facility.

2) Scope

This SOP applies to all departments and functions within the manufacturing facility that are responsible for initiating, evaluating, implementing, and verifying changes.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Change Control Board (CCB):

Responsible for reviewing and approving changes based on impact assessment and risk evaluation.

3.2 Change Initiator:

Responsible for initiating change requests and providing necessary documentation and justification.

3.3 Quality Assurance (QA) Specialist:

Responsible for assessing change impact on product quality and regulatory compliance and ensuring change control processes are followed.

4) Procedure

4.1 Change Request Initiation:

4.1.1 Identify the need for change and complete the Change Request Form.
4.1.2 Include details such as reason for change, scope, and potential impact.
4.1.3 Obtain approval from the Change Initiator’s supervisor.

4.2 Change Evaluation:

4.2.1 Review the Change Request Form for completeness and accuracy.
4.2.2 Assess the impact of the proposed change on product quality, safety, efficacy, and regulatory compliance.
4.2.3 Conduct risk assessment to determine the level of change control required.

4.3 Change Approval:

4.3.1 Present the change request and evaluation findings to the Change Control Board (CCB).
4.3.2 Obtain approval or rejection of the change request based on CCB decision.
4.3.3 Document CCB approval and communicate decisions to relevant stakeholders.

4.4 Change Implementation:

4.4.1 Develop an implementation plan including timelines, responsibilities, and resources.
4.4.2 Execute the change in accordance with approved procedures and protocols.
4.4.3 Verify and validate the effectiveness of the change through testing and validation activities.

4.5 Change Verification and Closure:

4.5.1 Verify completion of change implementation and compliance with approved procedures.
4.5.2 Close the Change Request Form and update relevant documentation and records.
4.5.3 Review and document lessons learned from the change management process.

5) Abbreviations, if any

CCB – Change Control Board
QA – Quality Assurance

6) Documents, if any

1. Change Request Form
2. Change Evaluation Report
3. Implementation Plan
4. Verification and Validation Reports

7) Reference, if any

1. FDA Guidance for Industry: Change Control – Implementation and Management Systems for Pharmaceutical and Biotechnology Manufacturing
2. ISO 13485 Medical devices – Quality management systems

8) SOP Version

Version 1.0

Standard Operating Procedure for Handling Deviations

1) Purpose

The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations from established processes or procedures to ensure product quality, compliance, and continuous improvement.

2) Scope

This SOP applies to all departments and processes within the manufacturing facility that may be subject to deviations impacting product quality, safety, or efficacy.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Deviation Coordinator:

Responsible for managing and overseeing the deviation handling process.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving deviation investigations and corrective actions.

3.3 Department Managers/Supervisors:

Responsible for initiating deviation reports and implementing corrective actions.

4) Procedure

4.1 Deviation Identification:

4.1.1 Identify and document deviations from established processes or procedures.
4.1.2 Classify deviations based on impact on product quality, safety, or regulatory compliance.
4.1.3 Assign a unique deviation number and enter details into the Deviation Log.

4.2 Deviation Investigation:

4.2.1 Form an investigation team including relevant stakeholders (e.g., QA, Production).
4.2.2 Conduct a thorough investigation to determine root cause(s) of the deviation.
4.2.3 Document investigation findings and conclusions.

4.3 Impact Assessment:

4.3.1 Evaluate the impact of the deviation on product quality and safety.
4.3.2 Determine the need for immediate corrective actions to prevent further deviation occurrence.
4.3.3 Notify QA and Production management of the deviation assessment.

4.4 Corrective and Preventive Actions (CAPA):

4.4.1 Develop and implement corrective actions to address root causes of the deviation.
4.4.2 Propose preventive actions to prevent recurrence of similar deviations.
4.4.3 Obtain QA approval of CAPA plans and monitor implementation timelines.

4.5 Deviation Closure and Documentation:

4.5.1 Verify completion and effectiveness of implemented corrective actions.
4.5.2 Close deviation report and document final disposition and approval.
4.5.3 Archive deviation records and maintain for regulatory inspections and audits.

5) Abbreviations, if any

QA – Quality Assurance
CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Deviation Log
2. Investigation Reports
3. CAPA Plans
4. Deviation Closure Records

7) Reference, if any

1. FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
2. ICH Q10 Pharmaceutical Quality System

8) SOP Version

Version 1.0

Standard Operating Procedure for Handling Customer Complaints

1) Purpose

The purpose of this SOP is to establish procedures for the receipt, documentation, investigation, and resolution of customer complaints to ensure timely and effective handling, customer satisfaction, and continuous improvement.

2) Scope

This SOP applies to all departments involved in the receipt and management of customer complaints within the facility.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Customer Service Representative:

Responsible for receiving and documenting customer complaints.

3.2 Quality Assurance (QA) Specialist:

Responsible for investigating and resolving customer complaints.

3.3 Sales and Marketing:

Responsible for communicating with customers regarding complaint resolutions.

4) Procedure

4.1 Complaint Receipt and Documentation:

4.1.1 Receive customer complaints via designated channels (e.g., phone, email, website).
4.1.2 Document complaint details including customer information, product details, and nature of complaint.
4.1.3 Assign a unique complaint identification number and enter complaint into the Complaint Log.

4.2 Complaint Evaluation and Investigation:

4.2.1 Evaluate the severity and potential impact of the complaint on product quality and safety.
4.2.2 Initiate investigation to determine root cause(s) of the complaint.
4.2.3 Gather relevant information and conduct necessary tests or analyses.

4.3 Corrective and Preventive Actions (CAPA):

4.3.1 Implement immediate corrective actions to address urgent complaints.
4.3.2 Develop and implement corrective and preventive actions (CAPA) based on investigation findings.
4.3.3 Monitor and verify effectiveness of CAPA through follow-up and review.

4.4 Resolution and Communication:

4.4.1 Communicate complaint resolution to the customer in a timely manner.
4.4.2 Provide appropriate compensation or replacement as per company policies.
4.4.3 Document resolution details and obtain customer acknowledgment if required.

4.5 Trend Analysis and Reporting:

4.5.1 Conduct trend analysis of customer complaints to identify recurring issues.
4.5.2 Report complaint trends and analysis findings to management.
4.5.3 Implement improvements to prevent recurrence of similar complaints.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Complaint Log
2. Investigation Reports
3. CAPA Records
4. Trend Analysis Reports

7) Reference, if any

1. ISO 10002: Customer Satisfaction – Guidelines for Complaints Handling in Organizations
2. FDA Guidance for Industry: Handling and Reporting of Adverse Events and Product Complaints in Medical Devices

8) SOP Version

Version 1.0