Standard Operating Procedure for Proper Shelving and Racking of Raw Materials

1. Purpose

This Standard Operating Procedure (SOP) outlines the correct procedures for shelving and racking raw materials in the warehouse to prevent contamination, ensure safety, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all shelving and racking activities in the warehouse, including the storage of Active Pharmaceutical Ingredients (APIs), excipients, and other raw materials.

3. Responsibilities

• Warehouse Personnel: Follow shelving and racking procedures, ensure materials are correctly placed, and report any irregularities.
• Warehouse Manager: Oversee shelving and racking operations, ensure compliance with SOP, and conduct routine inspections.
• Quality Assurance (QA): Verify the correct implementation of shelving procedures and conduct periodic audits.

4. Accountability

The Warehouse Manager is accountable for proper shelving and racking operations, while the QA Manager ensures compliance with GMP and regulatory standards.

5. Procedure

5.1 Shelving and Racking Requirements

1. Material Segregation:
   • Store raw materials according to their type (APIs, excipients, solvents) and physical properties.
   • Segregate materials based on status: Approved, Quarantined, and Rejected, using color-coded labels.
   • Document material placement in the Shelving Log (Annexure-1).
2. Racking Specifications:
   • Use metal shelving units with rust-resistant coatings and smooth surfaces to prevent contamination.
   • Ensure shelves are at least 6 inches off the floor and 18 inches from walls to facilitate cleaning and prevent pest infestation.
   • Document racking specifications in the Racking Configuration Log (Annexure-2).

5.2 Shelving and Racking Procedures

1. Material Placement:
   • Place heavier materials on lower shelves to prevent accidents and ensure stability.
   • Ensure labels on materials face outward for easy identification.
   • Document material placement in the Material Placement Log (Annexure-3).
2. FIFO and FEFO Implementation:
   • Follow First-In, First-Out (FIFO) and First-Expiry, First-Out (FEFO) principles to ensure proper material rotation.
   • Ensure older or near-expiry materials are easily accessible.
   • Document rotation activities in the FIFO/FEFO Log (Annexure-4).

5.3 Safety and Compliance

1. Load Capacity Management:
   • Do not exceed the load capacity specified by the racking manufacturer.
   • Ensure even weight distribution across shelves to prevent tipping or collapse.
   • Document load checks in the Load Capacity Log (Annexure-5).
2. Fire Safety and Accessibility:
   • Maintain clear access to fire exits, fire extinguishers, and emergency equipment.
   • Ensure materials are stored at least 18 inches below sprinkler systems to allow proper operation during emergencies.
   • Document fire safety inspections in the Fire Safety Inspection Log (Annexure-6).

5.4 Inspection and Maintenance

1. Routine Inspections:
   • Inspect shelving and racking systems weekly for structural integrity, signs of corrosion, and pest activity.
   • Report any damages or issues to the Warehouse Manager immediately.
   • Document inspections in the Shelving and Racking Inspection Log (Annexure-7).
2. Maintenance Procedures:
   • Perform maintenance activities, such as tightening loose bolts or replacing damaged shelves, as needed.
   • Document maintenance activities in the Maintenance Log (Annexure-8).

5.5 Handling of Deviations

1. Deviation Reporting:
   • Identify deviations, such as incorrect material placement, damaged shelving, or overloading.
   • Report deviations to QA and Warehouse Manager immediately.
   • Document deviations in the Deviation Log (Annexure-9).
2. Corrective Actions:
   • Implement corrective actions such as rearranging materials, replacing damaged racks, or retraining staff.
   • Document corrective actions in the Corrective Action Log (Annexure-10).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• FIFO: First-In, First-Out
• FEFO: First-Expiry, First-Out

7. Documents

1. Shelving Log (Annexure-1)
2. Racking Configuration Log (Annexure-2)
3. Material Placement Log (Annexure-3)
4. FIFO/FEFO Log (Annexure-4)
5. Load Capacity Log (Annexure-5)
6. Fire Safety Inspection Log (Annexure-6)
7. Shelving and Racking Inspection Log (Annexure-7)
8. Maintenance Log (Annexure-8)
9. Deviation Log (Annexure-9)
10. Corrective Action Log (Annexure-10)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO GMP Guidelines
• OSHA Warehouse Safety Standards

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Shelving Log

Annexure-2: Racking Configuration Log

Annexure-3: Material Placement Log

Annexure-4: FIFO/FEFO Log

Annexure-5: Load Capacity Log

Annexure-6: Fire Safety Inspection Log

Annexure-7: Shelving and Racking Inspection Log

Annexure-8: Maintenance Log

Annexure-9: Deviation Log

Annexure-10: Corrective Action Log

Revision History:

SOP for Cleaning Propellant Filling Lines

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for cleaning propellant filling lines in aerosol manufacturing. The purpose of this SOP is to ensure the effective removal of product residues, propellant remnants, and contaminants from the filling lines after each production run. Proper cleaning of the propellant filling lines is essential to prevent cross-contamination between product batches and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to the cleaning of all propellant filling lines used in aerosol manufacturing at [Company Name]. It covers the steps for cleaning propellant lines between production runs, especially when changing between different formulations or when different propellants are used. This SOP does not cover cleaning procedures for other equipment, such as filling machines or crimping machines, which are covered under separate SOPs.

3. Responsibilities

• Production Team: Responsible for cleaning the propellant filling lines after each production run and ensuring all procedures are followed to meet cleanliness standards.
• Maintenance Team: Responsible for assisting in the cleaning process, particularly when disassembling and reassembling parts of the filling lines. They also ensure that cleaning tools and equipment are in proper working condition.
• Quality Control (QC) Team: Responsible for verifying that cleaning processes meet the required standards and that there are no residues left in the lines that could affect product quality.
• Health and Safety Officer: Ensures that cleaning procedures are carried out in compliance with health and safety regulations, particularly with regards to handling cleaning agents and any propellant gases.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that the propellant filling lines are properly cleaned. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Cleaning Preparation

1. Before starting the cleaning process, ensure that the propellant filling lines are turned off and that all power and compressed air connections are safely disconnected.
2. Ensure that the lines are depressurized and that any remaining propellant has been safely purged from the system.
3. Gather the required cleaning materials, including:
   • Cleaning agents approved for use in propellant systems
   • Water or solvent for rinsing
   • Cleaning tools, including brushes, cloths, and sponges
   • Air blowers or compressed air for drying
   • PPE, such as gloves, goggles, and aprons
4. Inspect all cleaning tools and equipment to ensure they are clean and in good condition.
5. Verify that all cleaning agents used are compatible with propellant chemicals and are approved for use in manufacturing operations.

5.2. Cleaning Process

1. Begin by cleaning the external parts of the propellant filling lines, including pipes, connectors, and valves, using a damp cloth to remove any visible dust, dirt, or product residue.
2. For internal cleaning, flush the lines with an appropriate solvent or cleaning agent to remove product residues and any remaining propellant chemicals.
3. Use a brush to scrub any stubborn residues from internal surfaces, paying special attention to areas where propellant or product might have accumulated.
4. After the initial cleaning, rinse the lines thoroughly with clean water or another appropriate solvent to remove any remaining cleaning agents and residues.
5. For sensitive components, such as valves or pressure regulators, clean these using non-abrasive methods to avoid damage.
6. Once the lines have been rinsed, dry them thoroughly using compressed air or clean, lint-free cloths to ensure that no moisture remains inside the system.

5.3. Reassembly and Inspection

1. Once all parts have been cleaned and dried, carefully reassemble the propellant filling lines, ensuring that all components are correctly aligned and securely attached.
2. Inspect the lines for any signs of wear or damage during the cleaning process, particularly seals, gaskets, and valves. Replace any worn or damaged parts as necessary.
3. Conduct a visual inspection to ensure that all cleaning agents have been removed from the system and that the lines are clean and dry.
4. Run the lines through a short cycle with water or a test solution to check for leaks or operational issues before starting production. Ensure that all connections are secure and that there is no risk of contamination.

5.4. Post-Cleaning Testing

1. After the cleaning and reassembly, perform a test to ensure that the propellant lines are free of any cleaning agents or contaminants. This can include:
   • Sampling rinse water or testing for residue on internal surfaces of the lines
   • Conducting a pressure test to ensure that the lines are functioning correctly without leaks
2. Ensure that the results of the post-cleaning tests meet the established acceptance criteria. If the test results fail to meet the criteria, repeat the cleaning process until the required standards are achieved.
3. Document the results of the testing, including any corrective actions taken, in the Cleaning Validation Log (Annexure-1).

5.5. Safety and Environmental Considerations

1. Ensure that all cleaning activities are performed following safety guidelines and proper handling procedures for cleaning agents and propellants.
2. Ensure that all personnel involved in the cleaning process are wearing the appropriate PPE, including gloves, goggles, and protective aprons.
3. Dispose of any waste materials, including used cleaning agents and solvents, in compliance with environmental regulations and company policies.
4. Ensure that the cleaning process does not cause any environmental contamination, especially regarding the release of cleaning agents or solvents into the waste system or environment.

5.6. Documentation and Record-Keeping

1. Document all cleaning activities in the Cleaning Log (Annexure-2), including the date, operator name, cleaning agents used, machine parts cleaned, and any issues encountered during the cleaning process.
2. Ensure that all testing results, including sampling and pressure tests, are documented in the Cleaning Validation Log (Annexure-1) and are reviewed by the QC team.
3. Maintain cleaning and testing records according to the company’s document retention policy, ensuring that they are accessible for audits and inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• HPLC: High-Performance Liquid Chromatography

7. Documents

1. Cleaning Validation Log (Annexure-1)
2. Cleaning Log (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Cleaning Validation Log

Annexure-2: Cleaning Log

12. Revision History:

Standard Operating Procedure for Capsule Polishing Procedures

1. Purpose

The purpose of this SOP is to describe the procedure for polishing capsules during the manufacturing process. Capsule polishing enhances the appearance of capsules, removes any dust or residues, and ensures smooth, shiny, and uniform capsules for final packaging.

2. Scope

This SOP applies to all capsules that require polishing as part of the post-manufacturing process. It covers the equipment, materials, procedures, and documentation related to capsule polishing.

3. Responsibilities

• Manufacturing Team: Responsible for executing the capsule polishing procedures according to this SOP. Ensure that the polishing process is carried out safely and efficiently.
• Quality Control (QC) Team: Responsible for verifying the appearance and quality of capsules after polishing and ensuring that polishing parameters are within specifications.
• Quality Assurance (QA) Team: Ensures compliance with the SOP and reviews records related to the polishing process. Ensures that the process meets GMP and regulatory requirements.
• Maintenance Team: Responsible for ensuring that polishing equipment is regularly maintained and calibrated for optimal performance.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring the proper execution of the polishing procedure. The QA Manager is responsible for overseeing the entire process and ensuring that quality and compliance standards are maintained.

5. Procedure

5.1 Pre-Polishing Preparation

Before beginning the capsule polishing process, ensure the following preparations are made:

1. Equipment Setup
   1. Ensure that the polishing machine is clean and free from any residues from previous batches. Perform a thorough inspection of the polishing equipment, including rollers, brushes, and other components.
   2. Set up the polishing machine according to the manufacturer’s instructions. Verify that all settings, such as speed and temperature, are in compliance with the specifications for the current batch of capsules.
2. Polishing Materials
   1. Ensure that all materials used in the polishing process, such as polishing powder, wax, or vegetable-based lubricants, are approved for use and stored appropriately. Use only the recommended materials for the specific capsule type.
3. Documentation
   1. Document all preparation activities, including the setup of equipment and materials, in the batch production record (BPR). Note any deviations from the standard procedure.

5.2 Capsule Polishing Process

Follow these steps to polish the capsules:

1. Loading Capsules
   1. Carefully load the capsules into the polishing machine hopper, ensuring that the capsules are properly aligned to prevent damage during polishing.
   2. Do not overfill the hopper to avoid blockages or uneven polishing.
2. Polishing Action
   1. Start the polishing machine and allow it to operate according to the specified settings. During the polishing process, capsules will pass through rotating rollers or brushes coated with polishing materials.
   2. Monitor the capsules during the process to ensure uniform polishing. The machine speed should be adjusted as necessary to achieve the desired finish without causing damage to the capsules.
3. Polishing Material Application
   1. Ensure that the polishing material is applied evenly and that excess powder or wax is removed after polishing. Adjust the amount of polishing material if necessary to avoid over-coating the capsules.
4. Inspection
   1. After polishing, visually inspect the capsules for uniformity in appearance, shine, and smoothness. Capsules should be free from dust or residual polishing materials. Any defects should be recorded, and defective capsules should be segregated for rework or disposal.

5.3 Post-Polishing Actions

After the polishing process is complete, perform the following actions:

1. Final Inspection
   1. Inspect the polished capsules for the desired appearance, including a smooth, shiny surface free from blemishes, scratches, or foreign particles. Ensure that the capsules meet all visual standards.
   2. Check for any remaining polishing material on the surface of the capsules and remove any excess residue using an air blower or brush.
2. Segregation of Defective Capsules
   1. Immediately segregate any defective capsules identified during the final inspection. Place them in a “Rejected” container and document the defects for further action.
3. Documentation
   1. Document the polishing process in the batch production record (BPR), including the number of capsules polished, any defects found, and any corrective actions taken. Record the batch number and date of the polishing operation.
4. Packaging
   1. Once capsules have passed the final inspection, transfer them to the packaging area for further processing. Ensure that the polished capsules are carefully handled and properly stored until they are ready for packing.

5.4 Cleaning and Maintenance of Polishing Equipment

After completing the polishing process, ensure the polishing equipment is cleaned and maintained to prevent contamination in future batches:

1. Cleaning
   1. Clean all parts of the polishing machine, including rollers, brushes, and hoppers, to remove any remaining polishing powder or wax. Use approved cleaning agents and follow the manufacturer’s cleaning instructions.
2. Inspection
   1. Inspect the polishing equipment for wear and tear, and ensure that all moving parts are functioning smoothly. Replace any worn-out components as needed.
3. Documentation
   1. Document the cleaning and maintenance activities in the maintenance log. Record the date of cleaning, maintenance tasks performed, and any parts replaced or repaired.

5.5 Documentation and Record-Keeping

Ensure proper documentation of all polishing activities:

1. Batch Production Record (BPR)
   1. Document the polishing procedure in the BPR, including the batch number, quantity of capsules polished, any defects observed, and any corrective actions taken.
2. Inspection Log
   1. Maintain a log of all inspections performed during the polishing process, including the date, operator, and results of the inspection. Note any capsules that were rejected or reworked.
3. Maintenance Log
   1. Document any maintenance or cleaning activities performed on the polishing equipment, including the tasks completed, parts replaced, and the date of completion.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• BPR: Batch Production Record

7. Documents

1. Capsule Polishing Log (Annexure-1)
2. Polishing Defect Report (Annexure-2)
3. Equipment Maintenance Log (Annexure-3)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Capsule Polishing Log

Annexure-2: Polishing Defect Report

Annexure-3: Equipment Maintenance Log

Revision History:

Procedure for Water System Validation

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for the validation of water systems used in ointment manufacturing. Water system validation ensures that purified water, water for injection (WFI), and other process water meet the required quality standards for pharmaceutical production.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for water system qualification, validation, and routine monitoring.

3. Responsibilities

• QA Officer: Ensures compliance with water system validation protocols.
• Validation Team: Develops and executes water system validation protocols.
• Engineering Team: Maintains water purification and distribution systems.
• Production Supervisor: Ensures validated water is used in manufacturing processes.
• QA Manager: Reviews and approves water system validation reports.

4. Accountability

The QA and Engineering Managers are accountable for ensuring that water system validation is conducted as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Phases of Water System Validation

Water system validation consists of three key phases:

• Installation Qualification (IQ): Ensures that the water system is installed according to specifications.
• Operational Qualification (OQ): Confirms that the water system operates within established parameters.
• Performance Qualification (PQ): Verifies that the water system consistently produces water meeting quality specifications.

5.2 Installation Qualification (IQ)

• Verify the installation of water system components, including:
  • Storage tanks
  • Filtration units
  • Reverse osmosis (RO) membranes
  • Deionization units
  • UV sterilization units
  • Water distribution piping
• Check system piping for leaks and contamination risks.
• Ensure calibration of pressure and flow sensors.
• Document installation records and approve IQ reports.

5.3 Operational Qualification (OQ)

• Test the water system under normal operating conditions.
• Monitor key parameters such as:
  • Conductivity
  • Total Organic Carbon (TOC)
  • Microbial contamination levels
  • Endotoxin levels (for WFI systems)
  • pH and total dissolved solids (TDS)
• Check system performance at multiple sampling points.
• Ensure alarms and control mechanisms function correctly.
• Record OQ data and approve reports before proceeding to PQ.

5.4 Performance Qualification (PQ)

• Assess water system stability over an extended period.
• Monitor water quality parameters daily for at least 30 days.
• Ensure compliance with:
  • USP & EP specifications for purified water and WFI
  • Microbial count limits
  • Endotoxin levels within acceptable limits
• Document and approve PQ results before final validation approval.

5.5 Routine Monitoring and Revalidation

• Schedule routine water quality monitoring and system maintenance.
• Conduct periodic revalidation after major maintenance or modifications.
• Ensure continuous logging of conductivity, TOC, and microbial count.

5.6 Handling Deviations

• If water quality fails validation criteria:
  • Identify root cause and document findings.
  • Implement corrective and preventive actions (CAPA).
  • Requalify the water system after adjustments.
• Maintain deviation records for regulatory audits.

5.7 Documentation and Review

• Maintain all validation records in the Water System Validation Log.
• QA must review and approve all validation reports.
• Ensure records are available for regulatory inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• IQ – Installation Qualification
• OQ – Operational Qualification
• PQ – Performance Qualification
• CAPA – Corrective and Preventive Actions
• WFI – Water for Injection
• USP – United States Pharmacopeia
• EP – European Pharmacopeia
• TOC – Total Organic Carbon
• TDS – Total Dissolved Solids

7. Documents

• Water System Validation Protocol (Annexure-1)
• Water System Validation Log (Annexure-2)

8. References

• USP & EP Guidelines for Water System Validation
• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines for Pharmaceutical Water Systems
• US FDA Guidance on Water Systems in Pharmaceutical Facilities

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Water System Validation Protocol

Annexure-2: Water System Validation Log

Standard Operating Procedure for Capsule Batch Number Allocation and Tracking

1. Purpose

The purpose of this SOP is to define the procedure for allocating and tracking batch numbers for capsules produced during manufacturing. A systematic approach to batch number allocation ensures traceability, compliance with regulatory requirements, and effective quality control throughout the production process.

2. Scope

This SOP applies to all capsule production batches within the manufacturing facility. It covers the procedures for assigning batch numbers, documenting batch information, and maintaining records for tracking and traceability purposes.

3. Responsibilities

• Manufacturing Team: Responsible for ensuring that the correct batch numbers are assigned to the capsules during production and that batch records are accurately maintained.
• Quality Control (QC) Team: Responsible for verifying the batch number allocation and ensuring that proper documentation is maintained to facilitate traceability and auditing processes.
• Quality Assurance (QA) Team: Ensures compliance with the SOP, reviews batch records, and oversees the traceability system to ensure it meets regulatory requirements.
• IT and Records Management Team: Responsible for maintaining electronic systems and records to ensure accurate batch tracking and retrieval.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that batch numbers are allocated correctly and that proper tracking procedures are followed. The QA Manager is responsible for reviewing batch records and ensuring compliance with regulatory standards.

5. Procedure

5.1 Allocation of Batch Numbers

The following steps should be followed for allocating batch numbers during capsule production:

1. Batch Number Format
   1. Define the batch number format based on company standards. A typical format includes information such as the product code, production date, and a unique batch number (e.g., PROD-20250201-001).
   2. Ensure that the format is consistent across all batches to allow for easy identification and tracking.
2. Assignment of Batch Number
   1. Assign a unique batch number to each production batch. The batch number should be linked to the production record, raw material lot numbers, and other relevant manufacturing details.
   2. Batch numbers should be assigned in a sequential manner to prevent duplication and ensure traceability.
3. Record the Batch Information
   1. Record the batch number, product details, date of manufacture, and operator information in the batch production record (BPR). This will provide a comprehensive log of each batch produced, facilitating traceability.

5.2 Tracking of Batch Numbers

Once the batch number is assigned, ensure that the batch is tracked throughout the production and distribution process:

1. Documentation of Batch Details
   1. Ensure that all batch details, including the batch number, product specifications, raw material lot numbers, and equipment used, are documented in the batch production record and related documentation.
2. Batch Number on Packaging
   1. Ensure that the batch number is printed on the packaging of the capsules, including primary, secondary, and tertiary packaging, to ensure full traceability during distribution.
3. Real-Time Tracking System
   1. If available, use a computerized system to track batch numbers in real time. The system should be updated throughout the production process to provide immediate access to batch information for QC, QA, and regulatory purposes.
4. Inventory and Distribution Tracking
   1. Track each batch from production through to distribution, ensuring that the batch number is recorded at each stage of the supply chain. This includes storage, shipping, and delivery to customers or distributors.

5.3 Batch Number Traceability and Retrieval

Ensure that batch numbers can be traced and retrieved quickly for quality control, auditing, or regulatory inspections:

1. Batch Record Retrieval
   1. Maintain an organized system for storing batch records and related documents. Ensure that batch numbers are easily searchable and that records can be retrieved promptly upon request.
2. Audit Trail
   1. Maintain an audit trail for each batch, documenting any deviations, corrective actions, or changes made during the production process. This ensures transparency and traceability in case of any issues.
3. Regulatory Compliance
   1. Ensure that the batch tracking system complies with regulatory requirements, including FDA, EMA, or other relevant authorities, by providing access to batch records when requested.

5.4 Batch Number Reconciliation

To ensure accuracy in batch tracking, perform regular batch number reconciliation:

1. Reconciliation After Production
   1. Once a batch is completed, perform a reconciliation process to ensure that all materials used and capsules produced are accounted for under the correct batch number.
2. Reconciliation with Inventory Records
   1. Reconcile batch production records with inventory and distribution records to ensure that all capsules are properly accounted for and no discrepancies exist between the number of capsules produced and the number recorded in the system.

5.5 Batch Number Modifications

If any changes or modifications to the batch number are required, follow these procedures:

1. Documentation of Changes
   1. Any changes to batch numbers should be documented in the batch record, including the reason for the change and who authorized it. Ensure that all changes are made in compliance with GMP and regulatory standards.
2. Approval for Changes
   1. Changes to batch numbers should only be made with the approval of the QA Manager or another authorized individual to ensure traceability and prevent confusion or errors in batch tracking.

5.6 Documentation and Record-Keeping

Ensure proper documentation of all batch numbers and related activities:

1. Batch Production Records
   1. Maintain detailed batch production records for each batch produced, including batch number, raw materials, production conditions, and any deviations or issues encountered.
2. Batch Tracking Log
   1. Maintain a batch tracking log that documents all batch numbers, the status of each batch, and any actions taken throughout the production and distribution process.
3. Retention of Records
   1. Ensure that all batch production records and tracking logs are retained for the required period, in compliance with regulatory requirements, to allow for audits or inspections.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• BPR: Batch Production Record

7. Documents

1. Batch Production Record (Annexure-1)
2. Batch Tracking Log (Annexure-2)
3. Batch Number Allocation Form (Annexure-3)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Batch Production Record

Annexure-2: Batch Tracking Log

Annexure-3: Batch Number Allocation Form

Revision History:

Standard Operating Procedure for Real-Time Data Logging in In-Process Monitoring

1. Purpose

To define the procedure for real-time data logging during in-process monitoring of tablet manufacturing to ensure accurate recording, traceability, and compliance with production specifications.

2. Scope

This SOP applies to the real-time logging of manufacturing data during tablet production processes, such as compression, coating, and drying, to ensure consistent product quality and process control.

3. Responsibilities

• Quality Control (QC): Responsible for monitoring and logging in-process data and ensuring data integrity.
• Production Operator: Responsible for entering process data into the logging system as per the defined procedure and assisting in real-time monitoring of process parameters.
• Quality Assurance (QA): Reviews data logs to verify compliance with specifications and ensures that any deviations are investigated and addressed.

4. Accountability

The QC Manager is accountable for ensuring that data logging is conducted in real time and accurately recorded during all critical in-process activities. The QA Manager is responsible for reviewing and approving the logged data for compliance with quality standards.

5. Procedure

5.1 Setup and Configuration of Data Logging System

1. Ensure that the data logging system is set up and configured to collect relevant parameters for the tablet manufacturing process, including temperature, pressure, weight, and humidity, depending on the specific process step.
2. Verify that the system is calibrated and that all sensors and instruments connected to the data logging system are functioning correctly before starting the production batch.
3. Set the required data logging intervals (e.g., every minute or batch cycle) to ensure accurate real-time data collection.
4. Assign specific team members to monitor and verify the system during the batch production to ensure that data is being logged correctly.

5.2 Data Logging During Tablet Manufacturing

1. Start the data logging system at the beginning of the manufacturing process, ensuring that the parameters are being captured from the moment production begins.
2. Monitor the in-process data in real time, ensuring that the logged values remain within the established specifications (e.g., tablet weight during compression, temperature during coating, humidity during drying).
3. At regular intervals, ensure that the data is recorded without interruptions and that the system is capturing relevant data accurately.
4. If a process deviation occurs (e.g., temperature exceeds the set limit during coating), pause production, investigate the root cause, and document the issue in the deviation log (Annexure-1). Corrective actions should be implemented before continuing the process.

5.3 Real-Time Monitoring and Alerts

1. Ensure that the data logging system is equipped with real-time alerts for any out-of-specification (OOS) values. These alerts should notify the operator or QC personnel immediately if any monitored parameter goes beyond the defined acceptable limits.
2. When an alert is triggered, stop the production process, identify the source of the issue, and take corrective actions to bring the process back within specification.
3. Record all deviations and corrective actions in the batch record (Annexure-2) and the deviation report (Annexure-1).

5.4 Data Storage and Backup

1. Ensure that the data collected during the process is stored in a secure and backed-up location. This data must be retrievable for future review, audits, or regulatory inspections.
2. Data should be stored for a minimum period defined by company policy or regulatory requirements, ensuring that all records are traceable and accessible.
3. Perform routine data backups to prevent data loss. Ensure that backup data is stored in a secure and controlled environment to protect the integrity and confidentiality of the information.

5.5 Documentation and Review

1. Document all process parameters and logged data, including any deviations and corrective actions taken, in the batch record (Annexure-2).
2. Ensure that the data log is reviewed periodically by QA personnel to verify that all process parameters remain within acceptable limits and that corrective actions are appropriately documented.
3. If any discrepancies are found, investigate and resolve the issue immediately, documenting any changes made to the process in the deviation report (Annexure-1).

5.6 Acceptance Criteria

1. The logged data must fall within the predefined acceptable ranges for all critical process parameters.
2. If any process parameter exceeds the specified limits, corrective actions must be taken, and the batch may need to be reprocessed or rejected if it fails to meet quality standards.

5.7 Post-Process Actions

1. Once the batch is complete and all data has been logged, review the data log for accuracy and completeness. Ensure that all parameters were monitored according to the SOP.
2. Ensure that the data log is archived as part of the batch record for future reference and audit purposes.
3. Complete any necessary reports based on the logged data and submit them for final review and approval by QA personnel.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• OOS: Out of Specification

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• USP <1058> – In-Process Monitoring and Data Logging
• European Pharmacopoeia (EP) – Data Integrity and Logging for Manufacturing Processes

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Deviation Report

Annexure-2: Batch Record

Revision History:

Comprehensive Guide to Disposal of Rejected or Scrap Materials in Medical Device Manufacturing

1) Purpose

The purpose of this SOP is to define the procedures for handling, documenting, and disposing of rejected or scrap materials in medical device manufacturing. This ensures compliance with environmental regulations, prevents unauthorized reuse, and safeguards the integrity of production processes.

2) Scope

This SOP applies to all rejected raw materials, components, in-process products, and finished goods deemed unsuitable for use or sale. It is relevant to production staff, quality assurance personnel, and waste management teams.

3) Responsibilities

– Production Operators: Identify and segregate rejected or scrap materials during manufacturing processes.
– Quality Assurance (QA): Inspect and approve materials for disposal and document non-conformance details.
– Waste Management Team: Handle, transport, and dispose of materials following approved procedures.
– Environmental Compliance Officer: Ensure disposal processes meet local, national, and international environmental regulations.
– Supervisors: Oversee adherence to this SOP and ensure proper documentation.

4) Procedure

4.1 Identification of Rejected or Scrap Materials
4.1.1 Definition of Scrap and Rejected Materials
– Scrap materials: Residual materials generated during production that cannot be reused, such as cut-offs, shavings, or defective components.
– Rejected materials: Items that fail to meet quality standards during raw material inspection, in-process checks, or final product testing.

4.1.2 Identification and Documentation
– Tag rejected or scrap materials immediately with labels specifying the reason for rejection, batch/lot number, and date.
– Record details in the Rejection Log, including material type, quantity, and inspector initials.

4.2 Segregation and Storage
4.2.1 Designated Storage Areas
– Store rejected and scrap materials in designated, clearly labeled areas separate from usable inventory.
– Ensure storage areas are secure, clean, and comply with safety requirements.

4.2.2 Hazardous Materials
– Segregate hazardous scrap materials (e.g., chemical waste) from non-hazardous materials.
– Follow safety protocols for handling and storage to prevent contamination or harm.

4.2.3 Traceability
– Maintain traceability of rejected or scrap materials through batch/lot numbers and detailed records in the Rejection Log.

4.3 Approval for Disposal
4.3.1 Inspection by QA
– QA personnel must inspect all materials marked for disposal to confirm they are unsuitable for use.
– Approve materials for disposal by signing off in the Rejection Log.

4.3.2 Regulatory Review
– Obtain approval from the Environmental Compliance Officer for the disposal of hazardous or regulated materials.
– Verify that disposal methods align with local and international environmental laws.

4.4 Disposal Methods
4.4.1 Non-Hazardous Materials
– Dispose of non-hazardous scrap materials through recycling or general waste disposal methods, as applicable.
– Document the disposal method and service provider details in the Disposal Log.

4.4.2 Hazardous Materials
– Transport hazardous materials to certified waste disposal facilities in compliance with regulatory standards.
– Ensure that transporters hold valid permits for handling hazardous waste.

4.4.3 Destruction of Rejected Products
– For rejected finished products, ensure destruction is irreversible to prevent unauthorized reuse.
– Use shredding, incineration, or chemical neutralization methods, as appropriate.

4.4.4 Recycling
– Identify scrap materials suitable for recycling and coordinate with approved recycling vendors.
– Ensure recycled materials do not re-enter the production process unless approved for specific purposes.

4.5 Documentation and Record Keeping
4.5.1 Rejection Log
– Record all rejected materials in the Rejection Log, including material type, batch/lot number, quantity, and reason for rejection.

4.5.2 Disposal Log
– Maintain a Disposal Log documenting material type, disposal method, date, and responsible personnel.
– Include vendor details and certifications for hazardous waste disposal or recycling activities.

4.5.3 Certificates of Disposal
– Obtain certificates of disposal or destruction from waste disposal vendors for hazardous and rejected materials.
– Archive certificates as part of the disposal records.

4.6 Auditing and Compliance
4.6.1 Internal Audits
– Conduct regular internal audits to ensure adherence to this SOP and proper record-keeping.
– Address any non-compliance through corrective actions.

4.6.2 Regulatory Inspections
– Ensure all disposal records are readily accessible for regulatory inspections.
– Provide required documentation, such as disposal logs and certificates, to demonstrate compliance.

5) Abbreviations

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– EPA: Environmental Protection Agency

6) Documents

– Rejection Log
– Disposal Log
– Certificates of Disposal/Destruction
– Regulatory Compliance Records
– Vendor Certifications

7) Reference

– ISO 14001: Environmental management systems
– FDA CFR Title 21, Part 820: Quality System Regulation
– Local Environmental Protection Regulations
– Basel Convention on the Control of Transboundary Movements of Hazardous Wastes

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Rejection Log Template

Annexure 2: Disposal Log Template

Standard Operating Procedure for Preventive Maintenance of Capsule Manufacturing Equipment

1. Purpose

The purpose of this SOP is to establish a preventive maintenance program for the capsule manufacturing equipment to ensure its optimal performance, reduce downtime, and extend its operational life. Regular preventive maintenance is essential to minimize equipment failure and maintain product quality.

2. Scope

This SOP applies to all capsule manufacturing equipment, including capsule filling machines, gelatin preparation systems, capsule inspection systems, drying equipment, and sealing machines. It covers the preventive maintenance tasks, frequency, and documentation required to maintain equipment functionality.

3. Responsibilities

• Manufacturing Team: Responsible for notifying the maintenance team when equipment is due for maintenance and assisting with equipment shutdowns if required.
• Maintenance Team: Responsible for conducting regular preventive maintenance on all capsule manufacturing equipment, ensuring that the equipment is cleaned, calibrated, and operational.
• Quality Control (QC) Team: Responsible for ensuring that the equipment is functioning properly during production and that any maintenance issues that impact product quality are documented and addressed.
• Quality Assurance (QA) Team: Ensures that preventive maintenance activities are performed according to this SOP, verifies maintenance records, and ensures compliance with regulatory standards.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that preventive maintenance activities are carried out as scheduled. The QA Manager is responsible for ensuring compliance with this SOP and reviewing maintenance documentation.

5. Procedure

5.1 Pre-Maintenance Preparation

Before beginning any preventive maintenance task, ensure the following steps are completed:

1. Equipment Shutdown
   1. Ensure that the equipment to be serviced is properly shut down and that all safety procedures are followed. Disconnect electrical power if necessary and lock out/tag out the equipment to prevent accidental start-up.
2. Review Maintenance Schedule
   1. Review the maintenance schedule to ensure that the correct tasks are being performed on the equipment at the correct intervals. Maintenance schedules should be based on the manufacturer’s recommendations and the operating history of the equipment.
3. Tools and Spare Parts
   1. Ensure that all necessary tools, spare parts, and lubricants are available before beginning the maintenance work. Use only approved parts and materials for repairs or replacements.

5.2 Preventive Maintenance Tasks

Perform the following preventive maintenance tasks at the recommended intervals to ensure optimal performance of capsule manufacturing equipment:

1. Cleaning
   1. Clean all equipment parts, including capsule filling machines, hoppers, and capsules inspection units. Use approved cleaning agents and follow cleaning procedures to prevent contamination and ensure smooth operation.
2. Lubrication
   1. Lubricate all moving parts, including gears, motors, and conveyor systems, according to the manufacturer’s specifications. Use appropriate lubricants and check for signs of wear or damage to moving parts.
3. Inspection and Calibration
   1. Inspect equipment for wear, corrosion, or other damage. Calibrate systems such as weight sensors, filling mechanisms, and sealing units to ensure that the equipment operates within specified tolerances.
4. Check Electrical Systems
   1. Inspect all electrical connections, circuits, and components for signs of damage or overheating. Test the electrical systems to ensure proper functionality.
5. Inspect Air and Gas Systems
   1. Inspect pneumatic systems, air filters, and gas lines for leaks or blockages. Replace filters as needed to ensure a constant supply of clean air to the equipment.
6. Check for Alignment and Calibration
   1. Check the alignment of all mechanical components, including the capsule filling stations and sealing mechanisms. Ensure that all components are correctly aligned to prevent misalignment during production runs.

5.3 Post-Maintenance Verification

After completing the preventive maintenance tasks, perform the following steps:

1. Equipment Testing
   1. Test the equipment to ensure that it is functioning correctly after maintenance. Run a test batch of capsules to verify that the machine is operating smoothly and within specified parameters.
2. Verification of Adjustments
   1. Verify that any adjustments made during maintenance (e.g., machine settings, calibration) are correct. Document the adjustments made and any changes to equipment parameters.
3. Documentation
   1. Document all preventive maintenance activities in the equipment maintenance log. Include the date, tasks performed, parts replaced, and any issues identified during the maintenance process. Include the results of post-maintenance testing and verification.

5.4 Frequency of Preventive Maintenance

The frequency of preventive maintenance tasks depends on the manufacturer’s recommendations, equipment usage, and criticality. Ensure the following tasks are performed at regular intervals:

1. Daily
   • Visual inspection of equipment for damage or wear
   • Cleaning of equipment surfaces and components
   • Lubrication of moving parts as required
2. Weekly
   • Calibration checks on weight sensors, filling mechanisms, and sealing machines
   • Inspection of air filters and pneumatic systems
3. Monthly
   • Full system inspection, including electrical systems and mechanical components
   • Replacement of worn parts and filters

5.5 Emergency Maintenance

In case of unexpected breakdowns or equipment failure, follow these steps:

1. Shutdown and Isolation
   1. Immediately shut down the equipment and isolate it from the production line to prevent further damage or safety hazards. Ensure that all electrical power is disconnected and the equipment is locked out for safety.
2. Assessment and Repair
   1. Assess the cause of the breakdown and repair the equipment as quickly as possible. If necessary, call in specialized maintenance personnel to address the issue.
3. Post-Repair Testing
   1. Once repairs are made, test the equipment to ensure that it is fully operational and that no further issues exist. Verify that the equipment is running smoothly and within the specified operational parameters.
4. Documentation
   1. Document the cause of the breakdown, the repair actions taken, and the outcome of the post-repair testing. Include any adjustments made to the equipment during repairs.

5.6 Documentation and Record-Keeping

It is essential to maintain accurate records of all preventive maintenance activities:

1. Equipment Maintenance Log
   1. Document all preventive maintenance activities in the equipment maintenance log, including the tasks performed, parts replaced, and any corrective actions taken.
2. Maintenance Request Form
   1. For any non-routine maintenance or repairs, complete a maintenance request form detailing the issue, the urgency of the repair, and any necessary parts or tools.
3. Calibration and Inspection Records
   1. Keep records of all calibration and inspection activities for each piece of equipment, including the results and any corrective actions taken.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance

7. Documents

1. Equipment Maintenance Log (Annexure-1)
2. Maintenance Request Form (Annexure-2)
3. Calibration and Inspection Records (Annexure-3)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Equipment Maintenance Log

Annexure-2: Maintenance Request Form

Annexure-3: Calibration and Inspection Records

Revision History:

Standard Operating Procedure for Environmental Monitoring of Raw Material Warehouse

1. Purpose

This Standard Operating Procedure (SOP) defines the process for environmental monitoring in raw material warehouses to ensure compliance with Good Manufacturing Practices (GMP) and to maintain the quality of stored materials.

2. Scope

This SOP applies to all environmental monitoring activities, including temperature, humidity, particulate matter, and microbial contamination, within the raw material storage areas.

3. Responsibilities

• Warehouse Personnel: Perform routine environmental monitoring and report deviations.
• Quality Assurance (QA): Review and verify monitoring data, conduct audits, and ensure compliance with regulatory requirements.
• Warehouse Manager: Ensure monitoring equipment is functional and staff are trained on monitoring procedures.

4. Accountability

The Warehouse Manager is accountable for the implementation of environmental monitoring protocols, while the QA Manager ensures that all monitoring data meets GMP standards.

5. Procedure

5.1 Environmental Monitoring Parameters

1. Temperature Monitoring:
   • Measure and record warehouse temperature twice daily using calibrated thermometers or automated data loggers.
   • Acceptable temperature range: 15°C to 25°C unless specified otherwise for specific raw materials.
   • Document readings in the Temperature Monitoring Log (Annexure-1).
2. Humidity Monitoring:
   • Monitor and record relative humidity (RH) levels twice daily using hygrometers or automated systems.
   • Acceptable humidity range: 30% to 60% RH, with stricter controls for moisture-sensitive materials.
   • Document readings in the Humidity Monitoring Log (Annexure-2).
3. Particulate Monitoring:
   • Conduct particulate monitoring monthly using calibrated particle counters in designated areas.
   • Ensure levels are within acceptable limits as per ISO Class standards.
   • Document results in the Particulate Monitoring Log (Annexure-3).
4. Microbial Monitoring:
   • Perform microbial monitoring monthly using settle plates, contact plates, and air samplers.
   • Collect samples from high-touch surfaces, air vents, and other critical areas.
   • Document results in the Microbial Monitoring Log (Annexure-4).

5.2 Equipment Calibration and Maintenance

1. Calibration of Monitoring Devices:
   • Ensure all monitoring equipment (thermometers, hygrometers, particle counters) is calibrated quarterly by certified personnel.
   • Maintain calibration certificates and document calibration activities in the Equipment Calibration Log (Annexure-5).
2. Routine Equipment Maintenance:
   • Inspect monitoring equipment weekly for damage or malfunction.
   • Replace batteries, clean sensors, and ensure proper functioning of automated systems.
   • Document maintenance activities in the Equipment Maintenance Log (Annexure-6).

5.3 Handling of Deviations

1. Identification of Deviations:
   • Identify deviations when environmental conditions fall outside the acceptable range.
   • Immediately report deviations to the Warehouse Manager and QA for corrective action.
   • Document deviations in the Environmental Monitoring Deviation Log (Annexure-7).
2. Corrective and Preventive Actions (CAPA):
   • Investigate the root cause of deviations and implement corrective actions such as adjusting HVAC settings or relocating sensitive materials.
   • Document corrective and preventive actions in the CAPA Log (Annexure-8).

5.4 Review and Verification of Monitoring Data

1. Daily Review:
   • Warehouse Supervisors review temperature and humidity logs daily for completeness and accuracy.
   • Document reviews in the Daily Monitoring Review Log (Annexure-9).
2. QA Verification:
   • QA conducts monthly reviews of all environmental monitoring data to ensure compliance with GMP standards.
   • Document verification in the QA Verification Log (Annexure-10).

5.5 Periodic Audits and Reporting

1. Internal Audits:
   • QA conducts quarterly audits of environmental monitoring processes to identify gaps and areas for improvement.
   • Document audit findings in the Environmental Monitoring Audit Log (Annexure-11).
2. Reporting:
   • Prepare quarterly environmental monitoring reports summarizing findings, deviations, and corrective actions.
   • Submit reports to senior management for review.
   • Document reports in the Environmental Monitoring Report Log (Annexure-12).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• RH: Relative Humidity
• CAPA: Corrective and Preventive Actions

7. Documents

1. Temperature Monitoring Log (Annexure-1)
2. Humidity Monitoring Log (Annexure-2)
3. Particulate Monitoring Log (Annexure-3)
4. Microbial Monitoring Log (Annexure-4)
5. Equipment Calibration Log (Annexure-5)
6. Equipment Maintenance Log (Annexure-6)
7. Environmental Monitoring Deviation Log (Annexure-7)
8. CAPA Log (Annexure-8)
9. Daily Monitoring Review Log (Annexure-9)
10. QA Verification Log (Annexure-10)
11. Environmental Monitoring Audit Log (Annexure-11)
12. Environmental Monitoring Report Log (Annexure-12)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ISO 14644 – Cleanrooms and Associated Controlled Environments
• WHO GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Temperature Monitoring Log

Annexure-2: Humidity Monitoring Log

Annexure-3: Particulate Monitoring Log

Annexure-4: Microbial Monitoring Log

Annexure-5: Equipment Calibration Log

Annexure-6: Equipment Maintenance Log

Annexure-7: Environmental Monitoring Deviation Log

Annexure-8: CAPA Log

Annexure-9: Daily Monitoring Review Log

Annexure-10: QA Verification Log

Annexure-11: Environmental Monitoring Audit Log

Annexure-12: Environmental Monitoring Report Log

Revision History:

Procedure for Validation of Compressed Air Quality

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for the validation of compressed air quality used in ointment manufacturing. Proper validation ensures that compressed air meets required purity standards and does not contaminate the manufacturing environment or product.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for the validation, monitoring, and control of compressed air systems used in production and laboratory settings.

3. Responsibilities

• QA Officer: Ensures compliance with compressed air validation protocols.
• Validation Team: Develops and executes compressed air validation protocols.
• Engineering Team: Maintains and calibrates compressed air systems.
• Production Supervisor: Ensures validated compressed air is used in manufacturing.
• QA Manager: Reviews and approves compressed air validation reports.

4. Accountability

The QA and Engineering Managers are accountable for ensuring that compressed air validation is conducted as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Phases of Compressed Air Validation

Compressed air validation follows three key phases:

• Installation Qualification (IQ): Ensures compressed air system installation meets specifications.
• Operational Qualification (OQ): Confirms compressed air quality meets required parameters under operating conditions.
• Performance Qualification (PQ): Validates continuous air quality performance under real production conditions.

5.2 Installation Qualification (IQ)

• Verify installation of compressed air components:
  • Compressors
  • Air dryers
  • Filters (particulate, coalescing, and activated carbon)
  • Pressure regulators
• Check system piping for leaks and contamination.
• Confirm that all system components meet manufacturer specifications.
• Ensure proper calibration of pressure gauges and air quality sensors.
• Document installation records and approve IQ reports.

5.3 Operational Qualification (OQ)

• Test the compressed air system to verify operational effectiveness.
• Evaluate system performance under different conditions:
  • Pressure stability and regulation
  • Airflow capacity and distribution
  • Moisture and dew point control
  • Particulate and microbial contamination levels
• Check the effectiveness of alarms and control mechanisms.
• Record OQ data and approve reports before proceeding to PQ.

5.4 Performance Qualification (PQ)

• Assess compressed air system stability under actual production conditions.
• Monitor air quality parameters over multiple production cycles.
• Conduct air quality testing, including:
  • Particulate count (ISO 8573-1)
  • Oil contamination analysis
  • Moisture and dew point measurement
  • Microbial contamination testing
• Ensure that compressed air conditions meet GMP requirements.
• Document and approve PQ results before final validation approval.

5.5 Routine Monitoring and Revalidation

• Schedule routine compressed air performance monitoring.
• Conduct periodic revalidation after major maintenance or modifications.
• Ensure continuous logging of pressure, dew point, and particulate levels.

5.6 Handling Deviations

• If compressed air system fails validation criteria:
  • Identify root cause and document findings.
  • Implement corrective and preventive actions (CAPA).
  • Requalify compressed air system after adjustments.
• Maintain all deviation records for regulatory audits.

5.7 Documentation and Review

• Maintain all validation records in the Compressed Air Validation Log.
• QA must review and approve all validation reports.
• Ensure records are available for regulatory inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• IQ – Installation Qualification
• OQ – Operational Qualification
• PQ – Performance Qualification
• CAPA – Corrective and Preventive Actions
• ISO – International Organization for Standardization

7. Documents

• Compressed Air Validation Protocol (Annexure-1)
• Compressed Air Validation Log (Annexure-2)

8. References

• ISO 8573-1: Air Quality Standards
• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines for Compressed Air Validation
• US FDA Guidance on Compressed Air Systems in Pharmaceutical Facilities

9. SOP Version

Version 2.0

10. Approval Section

11. Annexures

Annexure-1: Compressed Air Validation Protocol