Procedure for Labeling Ointment Containers

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for labeling ointment containers to ensure accuracy, compliance with regulatory requirements, and Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for verifying, applying, and inspecting labels on ointment containers.

3. Responsibilities

• Packaging Operator: Ensures labels are correctly affixed to ointment containers.
• Packaging Supervisor: Monitors the labeling process and ensures compliance with specifications.
• Quality Assurance (QA) Officer: Verifies labeling accuracy and batch records.
• QA Manager: Approves the final labeled batch before release.

4. Accountability

The QA and Packaging Managers are accountable for ensuring that labeling operations comply with GMP standards and regulatory requirements.

5. Procedure

5.1 Pre-Labeling Checks

• Ensure that the packaging area is clean and free from previous batch materials.
• Verify that the correct labels are available as per the Batch Packaging Record (BPR).
• Confirm that the printing machine is set to the correct batch number, expiry date, and manufacturing date.

5.2 Labeling Process

• Adjust the labeling machine for proper label alignment.
• Ensure that each ointment container receives only one label.
• Monitor the label application process to prevent misalignment or wrinkling.

5.3 Inspection and Verification

• Perform a random sampling of labeled containers to verify label placement and adherence.
• Check for smudging, misprints, or missing information.
• QA must verify that all label information matches the batch records.

5.4 Handling of Defective Labels

• Separate and document any incorrectly labeled containers.
• Report labeling defects to the Packaging Supervisor and QA.
• Ensure that rejected labels are disposed of properly.

5.5 Documentation and Review

• Record all labeling activities in the Labeling Log.
• QA must approve the labeled batch before further packaging.
• Maintain all documentation for traceability and audits.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BPR – Batch Packaging Record

7. Documents

• Labeling Inspection Log (Annexure-1)
• Batch Labeling Verification Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q10 – Pharmaceutical Quality System
• USP <41> – Weights and Balances

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Labeling Inspection Log

Annexure-2: Batch Labeling Verification Report

12. Revision History:

Procedure for Assembling Packing Materials

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for assembling packing materials for ointment packaging. Proper assembly ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and product integrity.

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for selecting, verifying, and assembling packing materials before the packaging process.

3. Responsibilities

• Packaging Operator: Collects, inspects, and assembles packing materials.
• Packaging Supervisor: Ensures correct materials are issued and assembled as per batch records.
• Quality Assurance (QA) Officer: Verifies material integrity and compliance with specifications.
• QA Manager: Reviews and approves final packing material documentation.

4. Accountability

The QA and Packaging Managers are accountable for ensuring that packing materials meet quality and regulatory standards before packaging begins.

5. Procedure

5.1 Pre-Assembling Checks

• Ensure that the packaging area is clean and free from previous batch materials.
• Verify that the correct packaging materials are available for the assigned batch.
• Check that the required packing components (tubes, cartons, labels, inserts) are in good condition.

5.2 Packing Material Verification

• Compare received packing materials against the Batch Packaging Record (BPR).
• Ensure that labels match product specifications, including batch number and expiry date.
• Confirm that packaging materials are free from damage or contamination.

5.3 Assembling Packing Components

• Arrange primary packaging materials (e.g., ointment tubes) in the correct sequence.
• Verify the presence of secondary packaging components (e.g., cartons, inserts).
• Ensure that tamper-evident seals and batch-coded labels are available.

5.4 Documentation and Review

• Record all assembled packing materials in the Packaging Material Log.
• QA must verify assembled materials before final packaging begins.
• Any discrepancies must be documented, investigated, and resolved before proceeding.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BPR – Batch Packaging Record

7. Documents

• Packing Material Inspection Log (Annexure-1)
• Batch Packaging Verification Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q10 – Pharmaceutical Quality System
• USP <41> – Weights and Balances

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Packing Material Inspection Log

Annexure-2: Batch Packaging Verification Report

12. Revision History:

Procedure for QA Documentation Practices

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the documentation practices required for Quality Assurance (QA) activities in ointment manufacturing. Proper documentation ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and product quality standards.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for preparing, reviewing, maintaining, and archiving documentation related to manufacturing, testing, and quality control.

3. Responsibilities

• QA Officer: Ensures accurate and complete documentation of QA activities.
• QC Analyst: Records analytical and test results as per defined procedures.
• Production Supervisor: Ensures documentation of batch manufacturing records (BMR) and process deviations.
• QA Manager: Reviews and approves all QA documentation before final archiving.

4. Accountability

The QA and QC Managers are accountable for ensuring that all documentation is maintained as per GMP and regulatory requirements.

5. Procedure

5.1 General Documentation Requirements

• All documents must be prepared, reviewed, and approved as per defined formats.
• Handwritten entries must be clear, legible, and in permanent ink.
• Corrections must be made using a single-line strike-through, followed by initials and date.
• No overwriting or erasing of data is allowed.

5.2 Types of QA Documents

5.2.1 Batch Manufacturing Records (BMR)

• Must contain complete details of batch processing.
• Each entry must be signed and dated by responsible personnel.
• Reviewed and approved by QA before batch release.

5.2.2 Standard Operating Procedures (SOPs)

• All procedures must be documented and followed as per the approved SOPs.
• Each SOP must have a unique SOP number, version control, and approval signature.
• Any revision in SOPs must be documented with justification.

5.2.3 Quality Control Test Records

• All test results must be recorded with supporting raw data.
• Test results must meet predefined acceptance criteria.
• All analytical test results must be verified and approved by QA.

5.2.4 Deviation and Change Control Records

• All deviations must be recorded, investigated, and approved.
• Any changes in manufacturing processes must follow change control procedures.

5.2.5 Logbooks

• Equipment usage and cleaning logbooks must be maintained.
• Personnel entry and exit records must be updated regularly.

5.3 Review and Approval Process

• QA must review all completed records before batch release.
• QC must verify all analytical data before submission to QA.
• QA Manager must approve all critical documents before finalization.

5.4 Document Storage and Retention

• All documents must be stored in a designated QA archive.
• Retention periods for different documents must follow regulatory guidelines.
• Records must be easily retrievable for audits and regulatory inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• SOP – Standard Operating Procedure

7. Documents

• QA Documentation Checklist (Annexure-1)
• QA Document Review Log (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q7 – Good Manufacturing Practice Guide
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: QA Documentation Checklist

Annexure-2: QA Document Review Log

12. Revision History:

Procedure for Maintaining GMP Standards

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach to maintaining Good Manufacturing Practices (GMP) in ointment manufacturing. GMP ensures that products are consistently produced and controlled to meet quality standards and regulatory requirements.

2. Scope

This SOP applies to all personnel in the Production, Quality Assurance (QA), and Quality Control (QC) departments responsible for implementing and maintaining GMP standards in the manufacturing facility.

3. Responsibilities

• Production Operator: Ensures GMP compliance during manufacturing processes.
• Production Supervisor: Monitors GMP adherence and provides necessary training.
• QC Analyst: Conducts tests to verify GMP compliance.
• QA Officer: Conducts GMP audits and ensures regulatory adherence.
• QA Manager: Approves GMP policies and oversees implementation.

4. Accountability

The QA and Production Managers are accountable for ensuring that GMP standards are implemented, followed, and continuously improved.

5. Procedure

5.1 General GMP Requirements

• Ensure all manufacturing processes follow written and approved SOPs.
• Maintain clean and controlled production environments.
• Ensure proper documentation practices (Good Documentation Practices, GDP).

5.2 Facility and Equipment Compliance

• Keep production areas free from contamination and cross-contamination risks.
• Ensure regular maintenance and calibration of equipment.
• Document equipment cleaning and maintenance activities.

5.3 Personnel Hygiene and Training

• Ensure all personnel wear appropriate protective clothing.
• Maintain personal hygiene to prevent product contamination.
• Provide regular GMP training for all employees.

5.4 Material Handling and Storage

• Ensure raw materials and finished products are stored under proper conditions.
• Label all materials correctly to prevent mix-ups.
• Use a First-In-First-Out (FIFO) or First-Expiry-First-Out (FEFO) system.

5.5 Manufacturing Process Controls

• Monitor and document critical process parameters.
• Ensure in-process quality control checks are performed.
• Address deviations through corrective and preventive actions (CAPA).

5.6 Cleaning and Sanitation

• Follow approved cleaning procedures for all equipment and areas.
• Use validated cleaning agents and ensure proper documentation.
• Perform regular environmental monitoring.

5.7 Documentation and Record Keeping

• Maintain batch manufacturing records (BMR) and batch packaging records (BPR).
• Document all deviations and investigations.
• Ensure traceability of all processes and materials.

5.8 Internal Audits and Continuous Improvement

• Conduct regular GMP audits to identify compliance gaps.
• Implement corrective actions based on audit findings.
• Review GMP policies periodically for updates.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• BPR – Batch Packaging Record
• CAPA – Corrective and Preventive Action

7. Documents

• GMP Compliance Checklist (Annexure-1)
• GMP Audit Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q7 – Good Manufacturing Practice Guide
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: GMP Compliance Checklist

Annexure-2: GMP Audit Report

12. Revision History:

Procedure for Approving QC Results

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for approving Quality Control (QC) test results in ointment manufacturing. This ensures that test results are accurate, meet Good Manufacturing Practices (GMP), and comply with product specifications before product release.

2. Scope

This SOP applies to all personnel in the Quality Control (QC) and Quality Assurance (QA) departments responsible for reviewing, verifying, and approving QC test results for raw materials, in-process samples, and finished products.

3. Responsibilities

• QC Analyst: Conducts quality control tests and records test results.
• QC Supervisor: Reviews test results and ensures they meet acceptance criteria.
• QA Officer: Cross-checks QC data for completeness and accuracy.
• QA Manager: Approves QC test results before batch release.

4. Accountability

The QA and QC Managers are accountable for ensuring that QC results are reviewed, approved, and documented as per GMP and regulatory requirements.

5. Procedure

5.1 QC Data Review Process

• Ensure that all QC test results are recorded in the QC Test Report.
• Verify that raw data, instrument logs, and calibration records are complete.
• Check that QC tests were performed according to validated methods.

5.2 Verification of QC Test Results

5.2.1 Raw Material Testing

• Confirm that raw material test results meet predefined specifications.
• Ensure that raw material Certificate of Analysis (CoA) is reviewed and approved.

5.2.2 In-Process Testing

• Verify test results for pH, viscosity, and microbial contamination.
• Ensure that in-process test results meet process control parameters.

5.2.3 Finished Product Testing

• Check assay, microbial limits, and packaging integrity test results.
• Confirm that all test results meet final product specifications.

5.3 Handling Out-of-Specification (OOS) Results

• Identify test results that do not meet acceptance criteria.
• Initiate an OOS investigation following OOS procedures.
• Implement corrective and preventive actions (CAPA) if required.

5.4 Final Approval of QC Test Results

• Ensure all QC test results are reviewed by the QC Supervisor.
• QA Officer cross-verifies the QC data and signs off on test results.
• QA Manager provides final approval for batch release.

5.5 Documentation

• Record all approved QC test results in the QC Test Log.
• Ensure traceability of test reports for future audits.
• Store all test results securely for regulatory inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• CoA – Certificate of Analysis
• OOS – Out of Specification
• CAPA – Corrective and Preventive Action

7. Documents

• QC Test Report (Annexure-1)
• QC Test Approval Log (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• USP <1225> – Validation of Compendial Procedures
• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: QC Test Report

Annexure-2: QC Test Approval Log

12. Revision History:

Procedure for Conducting QA Audits in Ointment Manufacturing

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for conducting Quality Assurance (QA) audits in ointment manufacturing. The QA audit ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality standards.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA) and Compliance departments responsible for conducting internal and external audits of ointment manufacturing processes, facilities, equipment, and documentation.

3. Responsibilities

• QA Auditor: Conducts audits, identifies non-conformances, and prepares audit reports.
• Production Manager: Ensures manufacturing processes comply with GMP requirements.
• Quality Control (QC) Analyst: Supports QA audits by providing testing and laboratory documentation.
• Compliance Officer: Ensures regulatory requirements are met and oversees corrective actions.
• QA Manager: Reviews audit findings, approves reports, and monitors implementation of corrective actions.

4. Accountability

The QA Manager and Compliance Officer are accountable for ensuring that QA audits are conducted as per GMP and regulatory guidelines.

5. Procedure

5.1 Audit Planning

• Define the scope and objectives of the QA audit.
• Prepare an annual audit schedule covering all critical manufacturing processes.
• Identify audit criteria based on GMP regulations and company policies.
• Ensure that the audit team is trained and qualified.

5.2 Conducting the Audit

5.2.1 Facility and Equipment Inspection

• Verify that manufacturing areas comply with GMP cleanliness and safety standards.
• Check calibration and maintenance records of production equipment.
• Ensure that raw materials and finished products are stored as per defined conditions.

5.2.2 Process Compliance Audit

• Observe the adherence to standard operating procedures (SOPs).
• Review batch manufacturing records for completeness and accuracy.
• Verify in-process quality control checks and test result documentation.

5.2.3 Documentation and Record Review

• Ensure batch manufacturing records (BMR) and batch packaging records (BPR) are complete.
• Verify deviation reports and corrective actions taken.
• Ensure compliance with change control procedures.

5.2.4 Personnel Training and Hygiene

• Check that manufacturing personnel are trained as per regulatory requirements.
• Ensure hygiene and protective clothing standards are maintained.
• Verify documentation of training records.

5.3 Identifying Non-Conformances

• Classify audit findings into:
  • Critical: Issues affecting patient safety or regulatory compliance.
  • Major: Non-conformances that may impact product quality.
  • Minor: Issues that require procedural improvements.
• Document all observations in the QA Audit Report.

5.4 Corrective and Preventive Actions (CAPA)

• Discuss audit findings with relevant department heads.
• Develop a Corrective and Preventive Action (CAPA) plan.
• Ensure that corrective actions address the root cause of non-conformances.
• Set timelines for implementing corrective measures.

5.5 Follow-Up and Audit Closure

• Perform a follow-up audit to verify corrective actions have been implemented.
• Close the audit once all non-conformances have been resolved.
• Ensure that audit records are stored for regulatory review.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• CAPA – Corrective and Preventive Action
• BMR – Batch Manufacturing Record
• BPR – Batch Packaging Record

7. Documents

• QA Audit Checklist (Annexure-1)
• QA Audit Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: QA Audit Checklist

Annexure-2: QA Audit Report

12. Revision History:

Procedure for Handling Deviation Reports

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized approach for handling, investigating, and documenting deviations in pharmaceutical manufacturing processes. Proper deviation management ensures compliance with Good Manufacturing Practices (GMP) and regulatory requirements while maintaining product quality.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for identifying, reporting, investigating, and closing deviation reports in the manufacturing process.

3. Responsibilities

• Production Operator: Identifies and reports deviations observed during production.
• Production Supervisor: Investigates deviations and ensures corrective actions are taken.
• Quality Control (QC) Analyst: Evaluates deviations affecting product quality and performs necessary testing.
• Quality Assurance (QA) Officer: Reviews deviation reports, initiates corrective actions, and ensures compliance with regulatory standards.
• QA Manager: Approves the final deviation report and ensures preventive measures are implemented.

4. Accountability

The QA and Production Managers are accountable for ensuring that all deviations are properly recorded, investigated, and resolved in compliance with GMP and regulatory requirements.

5. Procedure

5.1 Identification of Deviations

• Deviations may occur in manufacturing, packaging, labeling, testing, or documentation.
• Common types of deviations include:
  • Minor: Deviations with minimal impact on product quality.
  • Major: Deviations that may impact product quality or regulatory compliance.
  • Critical: Deviations that affect patient safety or lead to batch rejection.
• Any observed deviation must be reported immediately to the Production Supervisor and QA department.

5.2 Deviation Reporting

• Complete a Deviation Report Form with the following details:
  • Date and time of occurrence
  • Location and process step where the deviation occurred
  • Detailed description of the deviation
  • Immediate corrective action taken (if any)
• Submit the Deviation Report to the QA department for review.

5.3 Deviation Investigation

• QA assigns an investigator to assess the deviation.
• The investigation should determine:
  • Root cause of the deviation
  • Impact on product quality and safety
  • Potential recurrence of the issue
• Conduct a risk assessment if the deviation affects product safety.

5.4 Corrective and Preventive Actions (CAPA)

• Based on the investigation findings, develop a Corrective and Preventive Action (CAPA) plan.
• Corrective actions should address the root cause of the deviation.
• Preventive measures should be implemented to prevent recurrence.
• Examples of CAPA include:
  • Updating SOPs or training personnel
  • Modifying equipment settings or processes
  • Improving material handling procedures

5.5 Approval and Closure

• QA Manager reviews and approves the deviation report.
• Ensure all corrective actions are implemented before closing the deviation.
• Record the deviation closure date and store the report for audit purposes.

5.6 Documentation

• Maintain all deviation reports in the Deviation Log.
• Ensure traceability of deviations, investigations, and CAPA actions.
• QA must review deviation trends periodically for continuous improvement.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• CAPA – Corrective and Preventive Action

7. Documents

• Deviation Report Form (Annexure-1)
• Deviation Log (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Deviation Report Form

Annexure-2: Deviation Log

12. Revision History:

Procedure for QA Oversight During Packing Operations

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized process for Quality Assurance (QA) oversight during packing operations in ointment manufacturing. This ensures that the packaging process meets Good Manufacturing Practices (GMP) requirements and that finished products comply with regulatory standards.

2. Scope

This SOP applies to all personnel in the QA and Production departments responsible for monitoring, verifying, and ensuring compliance with packing operations for ointment products.

3. Responsibilities

• QA Officer: Conducts in-process checks and ensures packing process adherence to standards.
• Production Operator: Performs packing operations according to approved procedures.
• Production Supervisor: Oversees packing operations and ensures compliance with QA guidelines.
• QA Manager: Reviews and approves packing records and ensures compliance with GMP regulations.

4. Accountability

The QA and Production Managers are accountable for ensuring that all packing operations are conducted as per regulatory requirements and that product integrity is maintained.

5. Procedure

5.1 Pre-Packing QA Checks

• Ensure that the packing area is clean and ready for operations.
• Verify that packing materials (tubes, cartons, labels) are QA-approved.
• Ensure that batch records and product specifications are available.

5.2 In-Process QA Oversight

5.2.1 Verification of Packing Materials

• Confirm that the correct batch number, expiry date, and manufacturing date are printed on packaging.
• Check that the correct labels and patient information leaflets are used.

5.2.2 Filling and Sealing Inspection

• Ensure that filled containers meet specified weight/volume requirements.
• Check for proper sealing of tubes to prevent leakage.
• Monitor random samples to confirm consistency in filling.

5.2.3 Labeling and Printing Verification

• Verify that labels are correctly aligned and securely affixed.
• Ensure that barcode and serialization numbers are correct.
• Check for smudging or misprints on labels.

5.2.4 Final Packing Inspection

• Ensure that packed units are uniform and meet appearance standards.
• Check for damaged or defective packaging materials.
• Verify the reconciliation of packing components.

5.3 Post-Packing QA Review

• Perform final verification of packed batch against specifications.
• Ensure that rejected units are properly documented and removed.
• QA must approve the packed batch before release for distribution.

5.4 Documentation

• Record all QA oversight activities in the Packing Oversight Log.
• Document any deviations and corrective actions taken.
• Ensure traceability by maintaining batch-wise records.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record

7. Documents

• Packing Oversight Log (Annexure-1)
• Packing Batch Approval Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q10 – Pharmaceutical Quality System
• USP <41> – Weights and Balances

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Packing Oversight Log

Annexure-2: Packing Batch Approval Report

12. Revision History:

Procedure for Validation of Manufacturing Processes

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a structured process for validating manufacturing processes in ointment production. Process validation ensures that manufacturing activities consistently produce products that meet predefined quality standards and regulatory requirements.

2. Scope

This SOP applies to all personnel in the Production, Quality Assurance (QA), and Quality Control (QC) departments involved in the validation of manufacturing processes, including mixing, heating, filling, and packaging.

3. Responsibilities

• Production Operator: Performs manufacturing activities as per validated procedures.
• Production Supervisor: Ensures process parameters are followed and recorded.
• Quality Control (QC) Analyst: Conducts in-process and final product testing.
• Quality Assurance (QA) Officer: Reviews validation protocols, ensures compliance, and approves validation reports.
• Validation Team: Conducts process qualification studies and risk assessments.

4. Accountability

The QA Manager and Validation Team are accountable for ensuring that all manufacturing processes are validated and compliant with Good Manufacturing Practices (GMP).

5. Procedure

5.1 Validation Planning

• Define the scope, objectives, and responsibilities of process validation.
• Prepare a Validation Master Plan (VMP) outlining the validation approach.
• Identify critical process parameters (CPP) and critical quality attributes (CQA).
• Establish acceptance criteria for validation.

5.2 Process Design Qualification (DQ)

• Ensure that equipment and facilities meet GMP design requirements.
• Verify equipment installation, calibration, and maintenance records.
• Review raw material specifications and ensure compatibility with process design.

5.3 Process Performance Qualification (PQ)

• Conduct trial production runs under controlled conditions.
• Collect process data, including mixing time, temperature, and viscosity.
• Analyze process variability and consistency across multiple batches.

5.4 Process Validation Execution

5.4.1 Validation Batches

• Perform three consecutive full-scale manufacturing runs.
• Monitor and record in-process parameters at critical points.
• Ensure batch-to-batch consistency in product characteristics.

5.4.2 Analytical Testing

• Conduct active ingredient assay, pH testing, and microbial analysis.
• Ensure uniformity of dosage and absence of contamination.
• Compare results against predefined acceptance criteria.

5.4.3 Stability Studies

• Conduct accelerated and real-time stability testing.
• Monitor physical and chemical stability over time.
• Ensure product retains its intended quality throughout its shelf life.

5.5 Process Validation Report (PVR)

• Summarize validation findings and statistical analyses.
• Document deviations and corrective actions taken.
• Obtain QA approval before the manufacturing process is officially validated.

5.6 Continuous Process Verification

• Monitor validated processes periodically to detect potential variations.
• Implement corrective actions if deviations exceed acceptable limits.
• Revalidate processes as per regulatory guidelines or after significant process changes.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• CPP – Critical Process Parameter
• CQA – Critical Quality Attribute
• PQ – Process Qualification
• PVR – Process Validation Report

7. Documents

• Validation Master Plan (Annexure-1)
• Process Validation Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q8 – Pharmaceutical Development
• USP <1225> – Validation of Compendial Procedures

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Validation Master Plan

Annexure-2: Process Validation Report

12. Revision History:

Procedure for Batch Manufacturing Record Review

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for reviewing Batch Manufacturing Records (BMR) to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and product quality standards.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for preparing, reviewing, and approving BMRs in ointment manufacturing.

3. Responsibilities

• Production Operator: Completes batch records and ensures accurate documentation of manufacturing activities.
• Production Supervisor: Verifies that records are properly filled out before submitting them to QA.
• Quality Control (QC) Analyst: Ensures all analytical results and test reports are documented correctly.
• Quality Assurance (QA) Officer: Reviews the BMR for completeness, accuracy, and compliance with specifications.
• QA Manager: Approves the final BMR for batch release.

4. Accountability

The QA and Production Managers are accountable for ensuring that BMRs are reviewed accurately and meet regulatory and GMP requirements before batch release.

5. Procedure

5.1 BMR Documentation Review

• Ensure that all pages of the BMR are included and properly numbered.
• Verify that the batch number, product name, and manufacturing date are correctly recorded.
• Ensure that all entries are legible and signed by authorized personnel.
• Confirm that corrections (if any) are made following proper documentation practices (single-line strike-through, initials, date).

5.2 Process and Equipment Review

• Verify that the correct equipment was used as per the master batch record.
• Ensure that cleaning and calibration records for the equipment are documented.
• Check that in-process control (IPC) tests were conducted at specified intervals.

5.3 Raw Material and Component Verification

• Ensure that all raw materials used are from approved sources.
• Verify that batch numbers of raw materials match the materials listed in the BMR.
• Check that material dispensing was performed as per the predefined quantity.

5.4 In-Process Quality Control (IPQC) Checks

• Verify that required in-process checks (e.g., pH, viscosity, temperature) are documented.
• Ensure that test results fall within the specified acceptance criteria.
• Confirm that deviations (if any) are documented and justified.

5.5 Packaging and Labeling Review

• Check that the correct packaging materials were used.
• Verify that label details (batch number, expiry date) are correct.
• Ensure that reconciliation of packaging materials is documented.

5.6 Deviations and Corrective Actions

• Identify and review any deviations recorded in the BMR.
• Ensure corrective actions taken are documented and approved.
• Confirm that deviation reports are closed before batch release.

5.7 Final Approval and Batch Release

• Ensure all sections of the BMR are completed and signed by authorized personnel.
• QA Manager must review and approve the final BMR.
• Once approved, the batch may be released for distribution.

5.8 Documentation

• Maintain copies of the reviewed and approved BMR for future audits.
• Record batch release details in the Batch Record Review Log.
• Ensure records are stored securely and accessible for regulatory inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• IPQC – In-Process Quality Control

7. Documents

• Batch Record Review Log (Annexure-1)
• Batch Release Approval Form (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• USP <1163> – Good Documentation Practices

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Batch Record Review Log

Annexure-2: Batch Release Approval Form

12. Revision History: