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:

Procedure for Line Clearance Before Production

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized procedure for performing line clearance before the start of production in the ointment manufacturing process. Line clearance ensures that the production area and equipment are free from any materials, documents, or residues from the previous batch, preventing cross-contamination and mix-ups.

2. Scope

This SOP applies to all personnel in the Production and Quality Assurance (QA) departments responsible for performing and verifying line clearance before the initiation of a new batch in ointment manufacturing.

3. Responsibilities

• Production Operator: Performs physical cleaning and removes unnecessary items from the production area.
• Production Supervisor: Ensures that line clearance activities are completed and documented properly.
• Quality Assurance (QA) Officer: Verifies the effectiveness of line clearance and provides final approval.
• Quality Assurance (QA) Manager: Reviews and ensures compliance with GMP guidelines before approving production startup.

4. Accountability

The QA and Production Managers are accountable for ensuring that line clearance is performed according to GMP standards and documented properly.

5. Procedure

5.1 Pre-Clearance Checks

• Ensure that the previous batch has been completed and all leftover materials have been removed.
• Verify that any rejected, quarantined, or unused materials are stored properly.
• Ensure that used equipment is cleaned and documented as per the cleaning SOP.
• Check that the production area is free from unwanted documents, tags, or labels.

5.2 Equipment Inspection

• Confirm that all machines are clean and in operational condition.
• Check calibration records of critical equipment (e.g., mixers, filling machines).
• Verify that all required tools and accessories are available.

5.3 Raw Material and Packaging Material Verification

• Confirm that only QA-approved raw materials and packaging components are present.
• Ensure that the correct labels and batch records are available.
• Verify that packaging material is not mixed with previous batches.

5.4 Environmental Conditions

• Ensure temperature and humidity levels are within specified limits.
• Check air filtration systems and ensure proper airflow.
• Verify that the production area meets cleanliness requirements.

5.5 Documentation and Approval

• Record all line clearance checks in the Line Clearance Log.
• QA personnel must verify and approve the line clearance checklist.
• Only after QA approval can the production process be initiated.

6. Abbreviations

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

7. Documents

• Line Clearance Log (Annexure-1)
• Line Clearance Approval Form (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• USP <1072> – Disinfection and Cleaning of Equipment

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Line Clearance Log

Annexure-2: Line Clearance Approval Form

12. Revision History:

Procedure for QA Review of Raw Materials

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for the Quality Assurance (QA) review of raw materials used in ointment manufacturing. This ensures compliance with specifications, regulatory requirements, and Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the QA, Quality Control (QC), and Production departments involved in the review, approval, and release of raw materials before use in manufacturing.

3. Responsibilities

• Quality Assurance (QA) Officer: Conducts the review of raw materials and associated documentation.
• Quality Control (QC) Analyst: Performs analytical and microbiological testing of raw materials.
• Warehouse Supervisor: Ensures proper storage and handling of raw materials.
• Production Manager: Ensures only QA-approved raw materials are used in production.

4. Accountability

The QA and QC Managers are accountable for ensuring that raw material review is conducted as per regulatory requirements and that only compliant materials are approved for use.

5. Procedure

5.1 Raw Material Documentation Review

• Check the Certificate of Analysis (CoA) from the supplier.
• Verify batch number, manufacturing date, and expiry date.
• Ensure compliance with predefined specifications.
• Review Material Safety Data Sheet (MSDS) for handling precautions.

5.2 Physical and Chemical Examination

• Inspect packaging integrity and labeling details.
• Verify the appearance, color, odor, and texture of raw materials.
• Ensure that no contamination, leakage, or tampering is observed.

5.3 Quality Control Testing

• Perform identification tests using analytical methods (e.g., HPLC, FTIR).
• Check pH, moisture content, and purity levels.
• Conduct microbiological testing to detect potential contamination.

5.4 Storage and Handling Review

• Confirm that raw materials are stored as per defined environmental conditions.
• Ensure segregation of approved, rejected, and quarantined materials.
• Monitor storage conditions (e.g., temperature, humidity).

5.5 Approval or Rejection

• If raw materials meet specifications, approve them for use.
• If materials fail to meet specifications, quarantine them and initiate corrective actions.
• Document approval or rejection status in the Raw Material Review Log.

5.6 Documentation

• Record all raw material review data in the QA Review Log.
• Attach relevant documents, including CoA, MSDS, and test results.
• QA must sign off on the final approval before raw material release.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• CoA – Certificate of Analysis
• MSDS – Material Safety Data Sheet

7. Documents

• Raw Material Review Log (Annexure-1)
• Raw Material Approval Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• USP <1116> – Microbiological Control and Monitoring

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Raw Material Review Log

Annexure-2: Raw Material Approval Report

12. Revision History:

Procedure for Recording Process Observations

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for recording process observations during ointment manufacturing. Proper documentation of observations ensures process control, traceability, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Production, Quality Control (QC), and Quality Assurance (QA) departments responsible for recording and reviewing process observations during manufacturing, filling, and packaging.

3. Responsibilities

• Production Operator: Records observations related to process conditions, material behavior, and equipment performance.
• Production Supervisor: Ensures observations are documented accurately and any deviations are reported.
• Quality Control Analyst: Reviews recorded observations and conducts additional testing if required.
• Quality Assurance (QA) Personnel: Reviews and approves observation records before batch release.

4. Accountability

The Production, QC, and QA Managers are accountable for ensuring that process observations are documented accurately and reviewed as per GMP and regulatory requirements.

5. Procedure

5.1 Equipment and Materials

• Batch Manufacturing Record (BMR)
• Process Observation Log
• Digital or manual recording sheets
• Temperature, pressure, and pH monitoring devices
• Weighing balance

5.2 Types of Process Observations

5.2.1 Raw Material Observations

• Check and record the condition of raw materials (e.g., color, texture, packaging integrity).
• Verify raw material identity before processing.
• Document any discrepancies in supplier specifications.

5.2.2 Mixing Process Observations

• Record temperature, speed, and duration of mixing.
• Observe viscosity changes and phase separation, if any.
• Document any unusual behaviors, such as foaming or clumping.

5.2.3 In-Process Testing Observations

• Document pH, viscosity, and homogeneity test results.
• Record any out-of-specification (OOS) findings and corrective actions taken.

5.2.4 Filling and Packaging Observations

• Monitor and document filling speed, accuracy, and volume deviations.
• Ensure proper labeling and packaging integrity.
• Record any incidents of leaking or mislabeling.

5.3 Process Documentation Requirements

• Observations should be recorded in real time.
• Corrections should be made using a single-line strike-through, with initials and date.
• Any deviations from standard parameters must be reported to the Production Supervisor.
• Final observations should be reviewed and approved before batch release.

5.4 Corrective Actions

• If any deviation is observed, immediately inform the supervisor.
• Document the corrective actions taken in the Process Observation Log.
• Ensure that affected products are held for further inspection before release.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record
• OOS – Out of Specification

7. Documents

• Process Observation Log (Annexure-1)
• Final Batch Observation Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q8 – Pharmaceutical Development
• USP <1163> – Quality Assurance in Pharmaceutical Compounding

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Process Observation Log

Annexure-2: Final Batch Observation Report

12. Revision History:

Procedure for Conducting On-the-Spot Microbial Testing

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a standardized method for conducting on-the-spot microbial testing in ointment manufacturing. This procedure ensures that the product remains free from microbial contamination at critical control points.

2. Scope

This SOP applies to Quality Control (QC) and Microbiology personnel responsible for performing on-the-spot microbial tests on raw materials, in-process samples, and finished ointments.

3. Responsibilities

• Microbiologist: Conducts microbial testing and records results.
• QC Analyst: Collects samples and ensures proper handling.
• Production Supervisor: Ensures adherence to microbial control measures.
• Quality Assurance (QA) Personnel: Reviews and approves microbial test reports.

4. Accountability

The QC and QA Managers are accountable for ensuring that microbial testing is performed accurately and documented as per GMP and regulatory guidelines.

5. Procedure

5.1 Equipment and Materials

• Sterile sampling swabs
• Agar plates (TSA, SDA, MacConkey)
• Petri dishes
• Incubator (30-35°C)
• Sterile forceps and gloves
• Laminar airflow hood
• Microbial testing logbook

5.2 Sampling for Microbial Testing

5.2.1 Raw Material Sampling

• Collect raw material samples using sterile containers.
• Test for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC).

5.2.2 In-Process Sampling

• Take samples at key process stages (e.g., mixing, filling).
• Use swab sampling on equipment and work surfaces.

5.2.3 Finished Product Sampling

• Randomly select filled containers for microbial testing.
• Test for the presence of specific pathogens (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa).

5.3 Microbial Testing Procedure

5.3.1 Total Aerobic Microbial Count (TAMC)

• Plate the sample on TSA (Tryptic Soy Agar).
• Incubate at 30-35°C for 48 hours.
• Count and record colony-forming units (CFU).

5.3.2 Total Yeast and Mold Count (TYMC)

• Plate the sample on SDA (Sabouraud Dextrose Agar).
• Incubate at 20-25°C for 5-7 days.
• Record fungal growth.

5.3.3 Pathogen Testing

• Use selective media for specific pathogens.
• Incubate at appropriate temperatures.
• Confirm results using biochemical tests.

5.4 Acceptance Criteria

• TAMC: Not more than 100 CFU/g.
• TYMC: Not more than 10 CFU/g.
• Pathogens: Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa must be absent.

5.5 Documentation

• Record all microbial test results in the Microbial Testing Log.
• Ensure that any deviations are documented and corrective actions taken.
• QA personnel must review and approve test results before batch release.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• TAMC – Total Aerobic Microbial Count
• TYMC – Total Yeast and Mold Count

7. Documents

• Microbial Testing Log (Annexure-1)
• Microbial Test Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• USP <1111> – Microbiological Examination of Nonsterile Products
• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Microbial Testing Log

Annexure-2: Microbial Test Report

12. Revision History:

Procedure for Verifying Labeling Accuracy

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for verifying labeling accuracy in ointment packaging. Proper labeling ensures compliance with regulatory requirements and prevents mix-ups, misbranding, and incorrect product identification.

2. Scope

This SOP applies to all personnel in the Production, Quality Control (QC), and Quality Assurance (QA) departments responsible for inspecting and verifying the accuracy of labels on ointment containers before batch release.

3. Responsibilities

• Production Operator: Ensures labels are applied correctly and match the product specifications.
• Production Supervisor: Monitors in-process labeling verification and resolves any issues.
• Quality Control Analyst: Conducts random label accuracy checks and records observations.
• Quality Assurance (QA) Personnel: Reviews and approves labeling documentation before product release.

4. Accountability

The Production, QC, and QA Managers are accountable for ensuring that labeling accuracy is verified and documented as per GMP and regulatory requirements.

5. Procedure

5.1 Equipment and Materials

• Automatic or semi-automatic labeling machine
• Barcode scanner (if applicable)
• Labeling specification sheet
• Reference sample of approved label
• Batch Manufacturing Record (BMR)
• Label Verification Log

5.2 Pre-Labeling Checks

• Ensure that the correct labels are used for the batch.
• Verify label content against the approved label specification.
• Check that the label printer is functioning correctly.
• Perform a trial label application on a dummy container before starting production.

5.3 In-Process Labeling Verification

5.3.1 Visual Inspection

• Inspect labels for legibility, clarity, and correctness.
• Ensure that batch number, expiry date, and manufacturing details are printed correctly.
• Check for smudging, misalignment, or label peeling.

5.3.2 Barcode and Serial Number Verification (if applicable)

• Scan the barcode on randomly selected units.
• Ensure the barcode matches the product database.
• Verify that serialization numbers are unique and properly recorded.

5.3.3 Random Sampling

• Collect a defined number of units (e.g., 10 per 1000 units) for label verification.
• Cross-check label details with the approved reference sample.
• Document any discrepancies and notify the Production Supervisor immediately.

5.4 Corrective Actions for Labeling Errors

• If a labeling error is detected, halt the labeling process immediately.
• Remove affected units from production.
• Identify the root cause (e.g., printer malfunction, incorrect roll of labels).
• Reprint and reapply labels as needed.
• Perform additional checks before resuming production.

5.5 Acceptance Criteria

• All printed details (batch number, expiry date, barcode, etc.) must be legible and match the BMR.
• Labels must be applied straight, without wrinkles, air bubbles, or misalignment.
• Any batch with more than 1% labeling defects must undergo full batch inspection.

5.6 Post-Labeling Verification

• Perform final visual inspection of labeled units before batch release.
• Ensure any rejected units have been properly documented and removed.
• QA personnel must review and approve the Label Verification Log.

5.7 Documentation

• Record all label verification results in the Label Verification Log.
• Document all corrective actions if labeling deviations occur.
• 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

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

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• USP <17> – Prescription Container Labeling
• ICH Q8 – Pharmaceutical Development

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Label Verification Log

Annexure-2: Final Batch Labeling Report

12. Revision History: