Purpose

The purpose of this SOP is to establish procedures for the execution of the sampling plan in stability studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the collection and management of stability study samples.

Responsibilities

• Quality Assurance: Responsible for oversight and approval of the stability study sampling plan execution.
• Quality Control: Responsible for the actual collection of stability study samples.
• Documentation Team: Responsible for recording and managing sample collection data.

Procedure

1. Review the approved Stability Study Protocol and Sampling Plan before initiating sample collection.
2. Verify that stability chambers or storage units are operating within specified conditions before starting sample collection.
3. Collect samples at designated time points according to the approved Sampling Plan.
4. Record relevant information for each sample, including Sample ID, Batch Number, Date of Collection, and Storage Conditions.
5. Handle samples with care to avoid contamination or degradation during the collection process.
6. Transport collected samples to the designated storage area promptly, ensuring maintenance of appropriate storage conditions.
7. Document any deviations from the Sampling Plan and report them to the Quality Assurance department.
8. Regularly update the sample inventory to reflect the current status and location of each sample.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Stability Study Protocol
• Approved Sampling Plan
• Sample Collection Record
• Sample Inventory Log

Reference

No external references are used in this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to establish procedures for the development of a sampling plan for stability studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the planning and execution of stability studies for pharmaceutical products.

Responsibilities

• Quality Assurance: Responsible for oversight and approval of the stability study sampling plan.
• Formulation and Development: Responsible for providing information on critical product attributes and factors affecting stability.
• Regulatory Affairs: Responsible for ensuring that the sampling plan complies with regulatory requirements.

Procedure

1. Review the stability study protocol to identify the specific requirements for sample collection and testing.
2. Collaborate with the Formulation and Development team to understand critical product attributes and potential degradation pathways.
3. Consider factors such as dosage form, packaging, storage conditions, and regulatory guidelines when developing the sampling plan.
4. Define the frequency and time points for sample collection based on the expected stability profile of the product.
5. Specify the number of samples to be collected at each time point, considering statistical and scientific principles.
6. Document the sampling plan in a detailed protocol, including rationale, acceptance criteria, and any deviations from standard procedures.
7. Obtain approval from the Quality Assurance department before implementing the sampling plan in the stability study.
8. Regularly review and update the sampling plan as needed, considering ongoing stability data and any changes in product formulation or manufacturing processes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Stability Study Protocol
• Sampling Plan Development Protocol
• Approved Sampling Plan

Reference

ICH Q1A (R2) – Stability Testing of New Drug Substances and Products

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to establish procedures for the validation of analytical methods used in stability studies for pharmaceutical products.

Scope

This SOP applies to all personnel involved in the development and execution of stability study analytical methods.

Responsibilities

• Quality Assurance: Responsible for overall oversight and approval of the analytical method validation process.
• Analytical Laboratory: Responsible for conducting method validation experiments and ensuring compliance with established procedures.
• Regulatory Affairs: Responsible for providing regulatory guidance on method validation requirements.

Procedure

1. Define the scope and objectives of the analytical method validation in accordance with regulatory requirements and study protocols.
2. Conduct a risk assessment to identify critical method parameters and potential sources of variability.
3. Develop a validation protocol outlining the experimental design, acceptance criteria, and validation schedule.
4. Perform precision, accuracy, linearity, specificity, and robustness studies as applicable to the specific analytical method.
5. Document all validation experiments, including raw data, calculations, and any deviations from the protocol.
6. Evaluate the results of the validation experiments against pre-established acceptance criteria.
7. Prepare a validation report summarizing the results, conclusions, and any recommendations for method improvements.
8. Obtain approval from the Quality Assurance department before implementing the validated analytical method in stability studies.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Analytical Method Validation Protocol
• Validation Report
• Method Validation Log

Reference

ICH Q2 (R1) – Validation of Analytical Procedures

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to establish procedures for the monitoring and control of storage conditions during stability studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the storage and monitoring of pharmaceutical products undergoing stability studies.

Responsibilities

• Quality Assurance: Responsible for overall oversight and approval of the storage condition monitoring process.
• Quality Control: Responsible for routine monitoring of storage conditions and reporting any deviations.
• Facility Management: Responsible for maintaining stability chambers and storage units.

Procedure

1. Ensure that stability chambers and storage units are appropriately qualified and calibrated.
2. Monitor and record storage conditions regularly, including temperature, humidity, and any other relevant parameters specified in the study protocol.
3. Place calibrated monitoring devices (e.g., data loggers) in strategic locations within stability chambers to ensure uniform conditions.
4. Implement an alarm system to notify personnel of any deviations from specified storage conditions.
5. Investigate and document any deviations from the specified storage conditions promptly. Take corrective actions as necessary.
6. Review and trend data to identify patterns and potential issues with storage conditions.
7. Document any changes in storage conditions due to maintenance activities and ensure that these changes are within acceptable limits.
8. Regularly review and update the monitoring schedule based on the requirements of the stability study.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Stability Study Protocol
• Storage Condition Monitoring Log
• Deviation Report

Reference

No external references are used in this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to establish the procedures for the proper management of stability study samples in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the collection, labeling, storage, and disposal of stability study samples conducted as part of the pharmaceutical product development process.

Responsibilities

• Quality Assurance: Responsible for overseeing and ensuring compliance with sample management procedures.
• Quality Control: Responsible for collecting, testing, and analyzing stability study samples.
• Sample Custodian: Responsible for the proper storage, labeling, and documentation of stability study samples.

Procedure

1. Clearly label each stability study sample with relevant information, including batch number, date of collection, and storage conditions.
2. Document the sampling process, including the quantity of samples collected, sampling location, and any deviations from the sampling plan.
3. Transfer samples to the designated storage area immediately after collection, ensuring that storage conditions are maintained as per study requirements.
4. Regularly monitor and record storage conditions, including temperature and humidity, for each stability chamber or storage unit.
5. Perform periodic checks on the integrity of sample containers and packaging to prevent contamination or degradation.
6. Maintain a detailed inventory of all stability study samples, including their current location, status, and any relevant testing schedule.
7. Dispose of samples in accordance with the approved procedures and regulatory guidelines once the stability study is complete.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Stability Study Sample Collection Log
• Stability Study Sample Inventory
• Stability Study Sample Disposal Record

Reference

No external references are used in this SOP.

SOP Version

Version 1.0

Purpose

The purpose of this SOP is to establish the procedures for the qualification of stability chambers used in the pharmaceutical industry.

Scope

This SOP applies to all stability chambers used for the storage of pharmaceutical products at various conditions to assess their stability over time.

Responsibilities

• Quality Assurance: Responsible for overall oversight and approval of the stability chamber qualification process.
• Quality Control: Responsible for executing the qualification protocols and conducting necessary testing.
• Engineering: Responsible for maintenance and calibration of stability chambers.

Procedure

1. Prepare a qualification protocol outlining the acceptance criteria and testing procedures for stability chambers.
2. Perform an Installation Qualification (IQ) to ensure that the stability chamber is installed correctly and meets the manufacturer’s specifications.
3. Conduct an Operational Qualification (OQ) to verify that the stability chamber operates within defined parameters under normal operating conditions.
4. Execute a Performance Qualification (PQ) to demonstrate that the stability chamber consistently maintains the required temperature and humidity levels over an extended period.
5. Document all test results, deviations, and corrective actions taken during the qualification process.
6. Review and approve the qualification report.
7. Periodically re-qualify stability chambers according to the defined schedule.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Stability Chamber Qualification Protocol
• Installation Qualification Report
• Operational Qualification Report
• Performance Qualification Report

Reference

No external references are used in this SOP.

SOP Version

Version 1.0

Purpose:
The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe and efficient operation of a Biological Oxygen Demand (BOD) incubator in a laboratory setting. The BOD incubator is used to maintain controlled environmental conditions for incubation of samples to measure oxygen demand.

Scope:
This SOP applies to all personnel involved in the operation and maintenance of the BOD incubator in the laboratory.

Responsibility:
Laboratory personnel: Responsible for operating the BOD incubator as per this SOP.
Laboratory Manager: Responsible for ensuring the availability, calibration, and maintenance of the BOD incubator.
Quality Assurance (QA): Responsible for reviewing and approving this SOP.

Procedure:
4.1. Equipment and Materials:
BOD incubator unit
Sample containers with BOD samples
Distilled water (if required for humidification)
Thermometer (if temperature control is not built-in)
Personal Protective Equipment (PPE) – lab coat, gloves, safety glasses
4.2. Pre-Operational Preparations:
4.2.1. Ensure that the BOD incubator is clean, free from debris, and in proper working condition.
4.2.2. Set the desired temperature on the BOD incubator, following the manufacturer’s instructions. If using a thermometer, set the temperature accordingly.
4.2.3. If the BOD incubator requires humidification, fill the water reservoir with distilled water as per the manufacturer’s instructions.
4.2.4. Ensure the availability of suitable sample containers with BOD samples.
4.2.5. Wear appropriate PPE, including a lab coat, gloves, and safety glasses.
4.3. Safety Precautions:
4.3.1. Follow all laboratory safety protocols and guidelines while operating the BOD incubator.
4.3.2. Avoid opening the BOD incubator unnecessarily during operation to prevent temperature and humidity fluctuations.
4.3.3. Use caution when handling sample containers to prevent spills or breakage.
4.3.4. Do not touch the BOD incubator unit or its electrical components with wet hands or when the unit is powered on.
4.3.5. If required, use appropriate precautions to prevent contamination of samples and cross-contamination between different samples.
4.4. Operation:
4.4.1. Place the sample containers with BOD samples inside the BOD incubator, ensuring they are stable and properly positioned.
4.4.2. Close the door of the BOD incubator and latch it securely to maintain airtight conditions.
4.4.3. Set the desired incubation temperature on the BOD incubator. Ensure it matches the requirements specified in the test method or protocol.
4.4.4. If humidification is required, follow the manufacturer’s instructions to activate the humidification system and set the desired humidity level.
4.4.5. Allow the BOD incubator to reach the set temperature and humidity levels. This may take some time depending on the incubator model and sample volume.
4.4.6. Monitor the temperature and humidity levels inside the BOD incubator using the built-in controls or external thermometer/hygrometer, ensuring they remain within the specified range.
4.4.7. Periodically check the samples inside the BOD incubator for any signs of contamination, leaks, or irregularities.
4.4.8. If required, rotate or shuffle the sample containers inside the BOD incubator to ensure even exposure to the incubation conditions.
4.4.9. Record the start time and date of the incubation in a logbook or appropriate records.
4.5. Periodic Monitoring:
4.5.1. Regularly monitor the temperature and humidity levels inside the BOD incubator throughout the incubation period.
4.5.2. Check for any equipment malfunctions, abnormal readings, or deviations from the set parameters.
4.5.3. Address any issues immediately by notifying the laboratory manager or relevant personnel.
4.6. Post-Incubation:
4.6.1. At the end of the incubation period, carefully remove the sample containers from the BOD incubator.
4.6.2. Inspect the samples for any changes or growth observed during the incubation.
4.6.3. Handle and dispose of the samples according to the laboratory’s waste management protocols.

Records:
5.1. Maintain a record of each BOD incubation, including the date, start time, temperature, humidity settings, incubation period, and any observations or issues encountered.
5.2. Document any corrective actions taken or maintenance performed on the BOD incubator.

Abbreviations: (if applicable)
BOD: Biological Oxygen Demand
PPE: Personal Protective Equipment

References:
Manufacturer’s operating instructions and technical specifications for the specific model of the BOD incubator being used.
Laboratory’s standard operating procedures for safety precautions and waste management.

Revision History:
Version 1.0: [Date of initial creation]
Provides the initial version of the SOP for the operation of the BOD incubator.
Version 1.1: [Date of revision]

[Specify the changes made during the revision, such as updates to the procedure, clarification of steps, or addition of new sections.]
Note: Any future revisions to this SOP should be documented and approved by the appropriate personnel before implementation.

Purpose:
The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe and effective operation of a hot water bath in a laboratory setting. The hot water bath is used for various applications such as sample heating, thawing, and maintaining constant temperature conditions.

Scope:
This SOP applies to all personnel involved in operating and maintaining the hot water bath in the laboratory.

Responsibility:
Laboratory personnel: Responsible for operating the hot water bath as per this SOP.
Laboratory Manager: Responsible for ensuring the availability and maintenance of the hot water bath.
Quality Assurance (QA): Responsible for reviewing and approving this SOP.

Procedure:
4.1. Equipment and Materials:
Hot water bath unit
Distilled water
Heat-resistant containers or vials
Thermometer (if temperature control is not built-in)
Personal Protective Equipment (PPE) – lab coat, gloves, safety glasses
4.2. Pre-Operational Preparations:
4.2.1. Ensure that the hot water bath is clean, free from debris, and in proper working condition.
4.2.2. Fill the hot water bath unit with distilled water to the appropriate level, ensuring it covers the immersion area or sample containers.
4.2.3. Ensure the availability of suitable heat-resistant containers or vials for placing samples in the hot water bath.
4.2.4. If the hot water bath does not have built-in temperature control, have a calibrated thermometer ready for temperature monitoring.
4.2.5. Wear appropriate PPE, including a lab coat, gloves, and safety glasses.
4.3. Safety Precautions:
4.3.1. Follow all laboratory safety protocols and guidelines while operating the hot water bath.
4.3.2. Be cautious when handling hot water or heated samples to avoid burns or injuries.
4.3.3. Use heat-resistant gloves or tools when manipulating samples in the hot water bath.
4.3.4. Avoid overfilling the hot water bath to prevent water spills and electrical hazards.
4.3.5. Do not touch the hot water bath unit or its electrical components with wet hands or when the unit is powered on.
4.4. Operation:
4.4.1. Set the desired temperature on the hot water bath unit, following the manufacturer’s instructions. If using a thermometer, set the temperature accordingly.
4.4.2. Allow the hot water bath to reach the set temperature, ensuring it stabilizes before placing samples.
4.4.3. Place the heat-resistant containers or vials containing the samples into the hot water bath, ensuring they are fully submerged and stable.
4.4.4. Close the lid or cover of the hot water bath unit to minimize heat loss and maintain temperature stability.
4.4.5. Set the timer if required, based on the process or incubation time.
4.4.6. Monitor the temperature of the hot water bath periodically using the built-in temperature control or the thermometer.
4.4.7. If necessary, adjust the temperature settings to maintain the desired temperature range.
4.4.8. Avoid opening the hot water bath unnecessarily during operation to prevent temperature fluctuations.
4.4.9. Once the required incubation or heating time is complete, carefully remove the samples from the hot water bath using appropriate tools or gloves.
4.4.10. Turn off the hot water bath unit and unplug it from the power source.
4.4.11. Allow the hot water bath to cool down before emptying the water and performing any cleaning or maintenance.
4.5. Post-Operational Procedures:
4.5.1. Empty the hot water bath unit by carefully draining the water into a suitable container or sink.
4.5.2. Clean the hot water bath unit by wiping the interior with a clean, damp cloth. If necessary, use a mild detergent solution to remove any residue or stains. Avoid getting water or cleaning agents on the electrical components.
4.5.3. Rinse the hot water bath unit with clean water to remove any detergent residue.
4.5.4. Dry the hot water bath unit thoroughly before storing it or using it again.
4.5.5. Dispose of any waste water and cleaning solutions in accordance with laboratory waste management protocols.
4.5.6. Record the usage details, including the date, time, temperature settings, duration of operation, and any observations or issues encountered during the operation, in a logbook or appropriate records.

Records:
5.1. Maintain a record of each hot water bath operation, including the date, time, temperature settings, duration of operation, and any observations or issues encountered.

Abbreviations: (if applicable)
PPE: Personal Protective Equipment

References:
Manufacturer’s operating instructions and technical specifications for the specific model of the hot water bath being used.
Laboratory’s standard operating procedures for safety precautions and waste management.

Revision History:
Version 1.0: [Date of initial creation]
Provides the initial version of the SOP for the operation of the hot water bath.
Version 1.1: [Date of revision]

[Specify the changes made during the revision, such as updates to the procedure, clarification of steps, or addition of new sections.]
Note: Any future revisions to this SOP should be documented and approved by the appropriate personnel before implementation.

Standard Operating Procedure (SOP): Operation of Laboratory Autoclave

Purpose:
The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and effective operation of a laboratory autoclave. This SOP ensures proper sterilization of laboratory equipment, media, and waste to maintain aseptic conditions.

Scope:
This SOP applies to all personnel involved in operating and maintaining the laboratory autoclave in a laboratory or testing environment.

Responsibility:
Laboratory personnel: Responsible for operating the laboratory autoclave as per this SOP.
Laboratory Manager: Responsible for ensuring the availability and maintenance of the laboratory autoclave.
Quality Assurance (QA): Responsible for reviewing and approving this SOP.

Procedure:
4.1. Equipment and Materials:
Laboratory autoclave
Autoclave-compatible items (e.g., equipment, media, waste)
Autoclave bags or containers
Autoclave tape or indicator strips
Personal Protective Equipment (PPE) – lab coat, gloves, safety glasses
4.2. Pre-Operational Preparations:
4.2.1. Ensure that the laboratory autoclave is clean, free from debris, and in proper working condition.
4.2.2. Familiarize yourself with the specific operating instructions and technical specifications provided by the manufacturer for the laboratory autoclave being used.
4.2.3. Check the availability and condition of autoclave-compatible items to be sterilized.
4.2.4. Ensure the availability of suitable autoclave bags or containers, as well as autoclave tape or indicator strips.
4.2.5. Wear appropriate PPE, including a lab coat, gloves, and safety glasses.
4.3. Safety Precautions:
4.3.1. Follow all laboratory safety protocols and guidelines while operating the laboratory autoclave.
4.3.2. Avoid overloading the autoclave beyond its capacity to ensure proper sterilization.
4.3.3. Ensure that the autoclave is placed on a stable surface and properly connected to a reliable power source.
4.3.4. Do not open the autoclave door during operation or while it is under pressure.
4.3.5. Familiarize yourself with the emergency stop or release mechanisms of the autoclave.
4.4. Operation:
4.4.1. Prepare the items to be sterilized, ensuring they are suitable for autoclaving and placed in autoclave bags or containers.
4.4.2. Ensure the autoclave bags or containers are properly sealed, leaving space for steam expansion during the sterilization process.
4.4.3. Place autoclave tape or indicator strips on the outside of the bags or containers to visually indicate successful sterilization.
4.4.4. Load the prepared items into the autoclave, arranging them to allow proper steam circulation and preventing any contact between bags or containers.
4.4.5. Close the autoclave door securely and ensure it is locked in place.
4.4.6. Set the desired sterilization parameters, such as temperature, pressure, and sterilization time, based on the requirements of the items being autoclaved.
4.4.7. Start the autoclave according to the manufacturer’s instructions, and allow it to reach the set temperature and pressure gradually.
4.4.8. Maintain the sterilization conditions (temperature and pressure) for the specified duration.
4.4.9. Once the sterilization process is complete, allow the autoclave to depressurize naturally or follow the manufacturer’s instructions for rapid depressurization, if applicable.
4.4.10. After depressurization, wait for the autoclave to cool down before opening the door.
4.4.11. Carefully open the autoclave door, ensuring there is no residual pressure inside.
4.4.12. Use caution when handling sterilized items as they may be hot. Allow them to cool down before removing them from the autoclave.
4.4.13. Inspect the autoclaved items for any signs of damage or inadequate sterilization. Discard any items that show signs of contamination or are damaged.
4.4.14. Record the sterilization details in a logbook, including the date, time, temperature, pressure, sterilization cycle, items sterilized, and any observations or notes.
4.5. Post-Operational Procedures:
4.5.1. Clean the autoclave chamber, racks, and trays using suitable cleaning agents and following the manufacturer’s instructions.
4.5.2. Empty and dispose of any autoclave waste properly, following laboratory waste management protocols.
4.5.3. Regularly inspect and maintain the autoclave, including cleaning filters, checking gaskets, and scheduling periodic maintenance as recommended by the manufacturer.

Records:
5.1. Maintain a record of each sterilization cycle conducted in the autoclave, including the date, start and stop times, temperature, pressure, items sterilized, and any observations or notes.

Abbreviations: (if applicable)
PPE: Personal Protective Equipment

References:
Manufacturer’s operating instructions and technical specifications for the specific model of the laboratory autoclave being used.
Laboratory’s standard operating procedures for safety precautions and waste management.

Revision History:
Version 1.0: [Date of initial creation]
Provides the initial version of the SOP for the operation of the laboratory autoclave.
Version 1.1: [Date of revision]

[Specify the changes made during the revision, such as updates to the procedure, clarification of steps, or addition of new sections.]
Note: Any future revisions to this SOP should be documented and approved by the appropriate personnel before implementation.

Purpose:
The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the safe and efficient operation of a centrifuge machine. This SOP ensures consistent and controlled separation of substances based on their density in a laboratory or testing environment.

Scope:
This SOP applies to all personnel involved in operating and maintaining the centrifuge machine in a laboratory or testing environment.

Responsibility:
Laboratory personnel: Responsible for operating the centrifuge machine as per this SOP.
Laboratory Manager: Responsible for ensuring the availability and maintenance of the centrifuge machine.
Quality Assurance (QA): Responsible for reviewing and approving this SOP.

Procedure:
4.1. Equipment and Materials:
Centrifuge machine
Rotor(s) suitable for the sample(s)
Sample(s) to be centrifuged
Appropriate centrifuge tubes or containers
Personal Protective Equipment (PPE) – lab coat, gloves, safety glasses
4.2. Pre-Operational Preparations:
4.2.1. Ensure that the centrifuge machine is clean, free from debris, and in proper working condition.
4.2.2. Familiarize yourself with the specific operating instructions and technical specifications provided by the manufacturer for the centrifuge machine being used.
4.2.3. Check the availability and condition of suitable rotors and centrifuge tubes or containers.
4.2.4. Wear appropriate PPE, including a lab coat, gloves, and safety glasses.
4.3. Safety Precautions:
4.3.1. Follow all laboratory safety protocols and guidelines while operating the centrifuge machine.
4.3.2. Ensure that the centrifuge machine is placed on a stable surface and balanced before operation.
4.3.3. Avoid overloading the rotor with samples beyond its capacity.
4.3.4. Do not open the centrifuge lid during operation or while the rotor is spinning.
4.3.5. Familiarize yourself with the emergency stop button or switch on the centrifuge machine.
4.4. Operation:
4.4.1. Load the sample(s) into suitable centrifuge tubes or containers, ensuring they are properly capped or sealed.
4.4.2. Check the rotor compatibility for the selected samples and install the appropriate rotor into the centrifuge machine.
4.4.3. Close the centrifuge lid securely and ensure it is locked in place.
4.4.4. Set the desired speed, time, and acceleration or deceleration rates according to the specific requirements of the samples or application.
4.4.5. Start the centrifuge machine and allow it to reach the desired speed gradually. Observe any abnormal noise or vibrations during the acceleration phase.
4.4.6. Once the desired speed is reached, maintain the centrifugation for the specified duration.
4.4.7. After the centrifugation process is complete, stop the machine and wait until the rotor comes to a complete stop before opening the lid.
4.4.8. Carefully remove the centrifuge tubes or containers, taking necessary precautions to avoid contamination or spills.
4.4.9. If necessary, transfer the separated components or samples to appropriate containers for further analysis or storage.
4.5. Post-Operational Procedures:
4.5.1. Clean the centrifuge machine, including the rotor and any spills or residues, following the manufacturer’s instructions.
4.5.2. Inspect the rotor for any signs of damage or wear and report any issues to the laboratory manager.
4.5.3. Dispose of any waste materials generated during the centrifugation process in accordance with laboratory waste management

Records:
5.1. Maintain a record of each operation conducted on the centrifuge machine, including the date, start and stop times, speed settings, duration of centrifugation, sample identification, and any observations or notes.

Abbreviations: (if applicable)
PPE: Personal Protective Equipment

References:
Manufacturer’s operating instructions and technical specifications for the specific model of the centrifuge machine being used.
Laboratory’s standard operating procedures for safety precautions and waste management.

Revision History:
Version 1.0: [Date of initial creation]
Provides the initial version of the SOP for the operation of the centrifuge machine.
Version 1.1: [Date of revision]

[Specify the changes made during the revision, such as updates to the procedure, clarification of steps, or addition of new sections.]
Note: Any future revisions to this SOP should be documented and approved by the appropriate personnel before implementation.