1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic and controlled sampling and testing of batches in the pharmaceutical manufacturing process. This SOP ensures that representative samples are collected and tested for quality attributes, ensuring that the batch meets the required specifications before release for further processing or distribution.

2. Scope

This SOP applies to all personnel involved in the batch sampling and testing process, including quality control personnel, production operators, and quality assurance staff.

3. Responsibilities

• Quality Control (QC) Personnel: Responsible for performing batch sampling and testing as per approved procedures and documenting the results accurately.
• Production Operators: Responsible for assisting in the sampling process and providing the required samples to the QC department.
• Quality Assurance (QA) Department: Responsible for overseeing the batch sampling and testing process and ensuring compliance with this SOP.
• Regulatory Affairs: Responsible for verifying that all required regulatory samples are collected and documented as per regulatory requirements.

4. Procedure

4.1 Sampling Plan:

• Develop a sampling plan that defines the number of samples to be collected, sampling locations, and the frequency of sampling.
• Ensure that the sampling plan follows approved procedures and is based on statistical principles to achieve representative samples.
• Document the sampling plan and obtain approval from the QA department before implementation.

4.2 Batch Sampling:

• Before sampling, clean and prepare the sampling containers or vessels to avoid cross-contamination.
• Follow the approved sampling plan to collect samples from the specified locations within the batch.
• Use appropriate sampling techniques, such as random sampling or stratified sampling, as per the sampling plan.
• Record the sampling details, including the date, time, location, and operator’s name, in the batch sampling log.

4.3 Sample Testing:

• Transfer the collected samples to the QC laboratory for testing as per the approved testing methods and specifications.
• Perform all required tests, inspections, and measurements on the samples, ensuring adherence to the defined test procedures.
• Use calibrated and validated testing equipment for accurate and reliable test results.
• Document the test results and observations in the batch testing records.

4.4 Sample Retention:

• After testing, retain a portion of the samples as per the sample retention policy for future reference or further investigations, if needed.
• Store the retained samples in a secure and controlled environment with proper labeling and traceability.
• Dispose of the retained samples according to the sample retention policy and regulatory guidelines.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6. Documents

The following documents are relevant to this SOP:

• Batch Sampling Plan
• Batch Sampling Log
• Batch Testing Records
• Sample Retention Policy

7. References

No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Batch Sampling and Testing, effective as of [Insert Date].

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic and thorough review and approval of batch records in the pharmaceutical manufacturing facility. This SOP ensures that each batch record is meticulously examined for accuracy, completeness, and compliance with approved procedures and regulatory requirements before approval for product release.

2. Scope

This SOP applies to all personnel involved in the batch record review and approval process, including quality assurance staff, quality control personnel, and production supervisors.

3. Responsibilities

• Quality Assurance (QA) Department: Responsible for conducting a detailed review of batch records to verify compliance with approved procedures and product specifications.
• Quality Control (QC) Personnel: Responsible for providing QC testing data and results for inclusion in the batch record.
• Production Supervisor: Responsible for coordinating with the QA and QC teams to ensure timely review and approval of batch records.
• Regulatory Affairs: Responsible for verifying regulatory compliance and documentation before batch record approval.

4. Procedure

4.1 Batch Record Compilation:

• Collect all relevant data, test results, and documentation related to the batch production process, including production records, quality control data, and any deviations or non-conformances encountered.
• Assemble the batch record in a standardized and organized manner for ease of review and verification.
• Include all required information, such as product name, batch number, manufacturing date, and details of the manufacturing process.

4.2 Review of Batch Record:

• Thoroughly review the batch record to ensure that all steps and procedures were followed correctly during the manufacturing process.
• Verify that all critical process parameters and quality control tests are within the specified limits and meet the product specifications.
• Check for any deviations, discrepancies, or non-conformances and ensure that they have been properly investigated and documented.
• Ensure that the data entries in the batch record are clear, complete, and legible.

4.3 Regulatory Compliance:

• Verify that the batch record complies with all applicable regulatory requirements, including Good Manufacturing Practices (GMP) and other relevant guidelines.
• Review any necessary regulatory approvals or clearances before approving the batch record for release.
• Ensure that all labeling and packaging requirements are met in accordance with regulatory guidelines.

4.4 Batch Record Approval:

• Based on the review findings and verification of regulatory compliance, the QA department will make a decision to approve or reject the batch record.
• If the batch record meets all criteria and requirements, it will be approved for product release.
• If any issues or discrepancies are identified, appropriate corrective actions must be taken before approving the batch record.
• Document the batch record approval decision, including any notes or recommendations, in the batch record itself.

5. Abbreviations

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

6. Documents

The following documents are relevant to this SOP:

• Batch Record Review and Approval Form
• Batch Record Compilation Checklist
• Regulatory Compliance Checklist

7. References

No specific external references are required for this SOP as it is based on internal company procedures and regulatory guidelines.

8. SOP Version

This is version 1.0 of the SOP for Batch Record Review and Approval, effective as of [Insert Date].

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic and controlled process of batch release and product release in the pharmaceutical manufacturing facility. This SOP ensures that each batch of pharmaceutical products undergoes thorough review, testing, and verification before being released for distribution or further use, thereby ensuring product quality and compliance with regulatory requirements.

2. Scope

This SOP applies to all personnel involved in the batch release and product release process, including quality assurance staff, quality control personnel, and production supervisors.

3. Responsibilities

• Quality Assurance (QA) Department: Responsible for reviewing batch records, test results, and product documentation to ensure compliance with product specifications and regulatory requirements.
• Quality Control (QC) Personnel: Responsible for performing tests and inspections on the batch samples as per approved procedures and documenting the results.
• Production Supervisor: Responsible for coordinating with the QA and QC teams to ensure timely release of batches.
• Regulatory Affairs: Responsible for coordinating with regulatory agencies for required approvals before product release.

4. Procedure

4.1 Batch Review and Documentation:

• Review the completed batch record and associated documentation to ensure all manufacturing steps and procedures were followed correctly.
• Verify that all required tests, inspections, and measurements have been performed and documented as per approved procedures.
• Ensure that all deviations and non-conformances are properly investigated, documented, and resolved before release.
• Document the batch review findings, including any discrepancies and corrective actions taken, for future reference.

4.2 Quality Control Testing:

• QC personnel should perform all required tests and inspections on the batch samples as per approved testing methods and specifications.
• Ensure that the testing equipment used is calibrated and in a state of proper functioning.
• Record the test results accurately and legibly in the appropriate batch documentation.
• Notify the QA department immediately if any batch fails to meet the specified quality standards.

4.3 Regulatory Compliance:

• Obtain all required regulatory approvals and certifications before releasing the batch for distribution or commercial use.
• Coordinate with the regulatory affairs department to ensure that all necessary documentation is complete and submitted as per regulatory requirements.
• Ensure that the product labeling and packaging comply with all applicable regulatory guidelines.

4.4 Batch Release Decision:

• Based on the batch review and quality control testing results, the QA department will make a decision to approve or reject the batch for release.
• If the batch meets all quality and regulatory requirements, it will be approved for release.
• If any issues or deviations are identified, appropriate corrective actions must be taken before considering the batch for release.
• Document the batch release decision, including the reasons for approval or rejection, in the batch records.

5. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control

6. Documents

The following documents are relevant to this SOP:

• Batch Review and Release Form
• Quality Control Test Results and Reports
• Regulatory Approvals and Certifications

7. References

No specific external references are required for this SOP as it is based on internal company procedures and regulatory guidelines.

8. SOP Version

This is version 1.0 of the SOP for Batch Release and Product Release, effective as of [Insert Date].

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper preparation and documentation of batch records in the pharmaceutical manufacturing process. This SOP ensures that batch records are accurately and comprehensively documented, reflecting all critical steps, measurements, and observations during the production of pharmaceutical products.

2. Scope

This SOP applies to all personnel involved in the batch record preparation and documentation process, including production operators, quality control personnel, and quality assurance staff.

3. Responsibilities

• Production Operators: Responsible for recording all information and data during the production process accurately and legibly in the batch record.
• Quality Control (QC) Personnel: Responsible for reviewing and verifying the accuracy and completeness of the recorded data in the batch record.
• Quality Assurance (QA) Staff: Responsible for approving and maintaining the batch records and ensuring compliance with this SOP.
• Production Supervisor: Responsible for overseeing the batch record preparation process and addressing any deviations or issues.

4. Procedure

4.1 Batch Record Format:

• Use a standardized batch record format that includes clear headings, spaces for data entry, and sequential numbering for easy tracking.
• Include the product name, batch number, manufacturing date, and other essential details at the beginning of the batch record.
• Ensure that the batch record format complies with regulatory requirements and internal quality standards.

4.2 Recording of Data:

• Record all critical steps, measurements, calculations, and observations during the production process in real-time.
• Use clear and legible handwriting when documenting data in the batch record.
• Include specific details such as equipment used, batch size, processing times, and any deviations encountered with explanations.
• Review data entries for accuracy and completeness before finalizing the batch record.

4.3 Review and Verification:

• QC personnel should review the batch record for completeness, accuracy, and compliance with standard procedures.
• Verify that all required signatures, approvals, and dates are present in the batch record.
• Document any discrepancies or deviations found during the review process and take appropriate corrective actions.

4.4 Batch Record Approval:

• Submit the completed batch record to the QA department for final review and approval.
• QA staff should ensure that the batch record is complete, accurate, and in compliance with regulatory requirements.
• Once approved, maintain the batch record securely as a part of the batch documentation.

4.5 Batch Record Retention:

• Maintain the batch records in a controlled and organized manner.
• Follow the company’s record retention policy and regulatory requirements for the storage and retention of batch records.
• Store the batch records in a secure and easily retrievable location for a defined period as per company policy.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6. Documents

The following documents are relevant to this SOP:

• Standard Batch Record Format
• Batch Record Review and Approval Form
• Batch Record Retention and Archiving Policy

7. References

No specific external references are required for this SOP as it is based on internal company procedures and regulatory requirements.

8. SOP Version

This is version 1.0 of the SOP for Batch Record Preparation and Documentation, effective as of [Insert Date].

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the verification and calibration of equipment used in the pharmaceutical manufacturing process. This SOP ensures that all equipment is regularly checked for accuracy, precision, and compliance with required specifications to maintain the quality and integrity of the products.

2. Scope

This SOP applies to all equipment used in the manufacturing process, including but not limited to, weighing scales, temperature controllers, pressure gauges, and pH meters.

3. Responsibilities

• Equipment Operators: Responsible for performing daily visual checks of the equipment and reporting any abnormalities to the maintenance team.
• Maintenance Team: Responsible for conducting regular verification and calibration of equipment as per the defined schedule.
• Quality Assurance (QA) Department: Responsible for overseeing the verification and calibration processes, ensuring compliance with this SOP.
• Production Manager: Responsible for ensuring that equipment verification and calibration are performed timely and as per schedule.

4. Procedure

4.1 Daily Visual Checks:

• Operators should visually inspect the equipment before use to ensure that there are no visible damages, leaks, or abnormal readings.
• Report any abnormalities or malfunctions to the maintenance team immediately.
• Keep a log of daily visual checks and maintenance reports for future reference.

4.2 Verification of Equipment:

• Establish a schedule for regular equipment verification based on manufacturer recommendations and industry standards.
• Ensure that the verification process includes functional testing, accuracy checks, and comparison with reference standards.
• Record the verification results, including any deviations, and take appropriate actions if the equipment does not meet the required criteria.
• Calibrate the equipment if necessary before returning it to operational use.

4.3 Calibration of Equipment:

• Establish a calibration schedule based on equipment criticality and industry best practices.
• Use calibrated reference standards with traceability to national or international standards for calibration purposes.
• Follow the manufacturer’s guidelines and standard operating procedures for equipment calibration.
• Document the calibration results, adjustments made, and the calibration due date for each piece of equipment.

4.4 Equipment Labeling:

• Label each equipment with a calibration status tag indicating the date of the last calibration and the next due date.
• Clearly mark equipment that is under verification or calibration to prevent accidental use.
• Remove “Out of Calibration” tags only after completing the verification and calibration processes successfully.

5. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance

6. Documents

The following documents are relevant to this SOP:

• Equipment Verification and Calibration Schedule
• Equipment Maintenance Log
• Calibration Certificates and Reports

7. References

Refer to the manufacturer’s guidelines and industry standards for specific equipment verification and calibration procedures.

8. SOP Version

This is version 1.0 of the SOP for Equipment Verification and Calibration, effective as of [Insert Date].

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe and proper handling and transportation of tablets within the manufacturing department. This SOP aims to minimize the risk of tablet damage, contamination, and mix-up during handling and transportation, ensuring the tablets’ integrity and quality throughout the manufacturing process.

2. Scope

This SOP applies to all personnel involved in the handling and transportation of tablets within the manufacturing department, including operators, technicians, and quality control staff.

3. Responsibilities

• Operators: Responsible for handling and transporting tablets as per this SOP and reporting any issues or deviations.
• Quality Control (QC) Personnel: Responsible for inspecting tablets before and after transportation to ensure they meet the required quality standards.
• Production Supervisor: Responsible for overseeing the tablet handling and transportation processes and addressing any operational concerns.

4. Procedure

4.1 Pre-Handling Preparations:

• Wear appropriate personal protective equipment (PPE), such as gloves and lab coats, before handling tablets to prevent contamination.
• Ensure that hands are clean and free from any residues before handling tablets.
• Verify the product name, batch number, and any other relevant details before starting the handling process.
• Inspect the tablet containers for any damage or signs of contamination before handling.

4.2 Handling of Tablets:

• Handle tablets with care and avoid dropping, crushing, or damaging them during the handling process.
• Use appropriate tools, such as clean and approved scoops or spatulas, to transfer tablets between containers.
• Avoid direct contact between tablets and hands to prevent potential contamination and maintain tablet quality.
• Ensure that tablets are handled in a manner that prevents mixing up different batches or products.
• Label any temporary containers or transfer vessels with the necessary information, such as product name, batch number, and quantity.

4.3 Tablet Transportation:

• Use dedicated and clean transportation carts or containers for moving tablets within the manufacturing department.
• Securely place the tablet containers on the transportation carts to prevent any spillage or breakage during transportation.
• Avoid excessive shaking, vibration, or sudden movements of the transportation carts to minimize tablet damage.
• Ensure that the transportation route is clean, clear, and free from potential hazards that could impact tablet integrity.
• Keep a record of tablet transportation activities, including the destination, quantity, and personnel responsible.

4.4 Post-Handling Checks:

• After handling and transportation, inspect tablets for any visible defects or damages.
• Report any discrepancies or abnormalities to the production supervisor and QC personnel for investigation.
• Sanitize the transportation carts and handling equipment regularly to prevent cross-contamination between different batches or products.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control
PPE: Personal Protective Equipment

6. Documents

The following documents are relevant to this SOP:

• Handling and Transportation Log
• Inspection and Deviation Reporting Form
• Sanitization Schedule for Transportation Carts

7. References

No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Handling and Transporting Tablets within the Manufacturing Department, effective as of [Insert Date].

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the effective inventory control and stock rotation of pharmaceutical products within the manufacturing facility. This SOP aims to ensure that the oldest stock is used first (first-in-first-out, FIFO), minimize product expiry, prevent stock outs, and maintain accurate inventory records.

2. Scope

This SOP applies to all personnel involved in inventory management, stock handling, and product distribution, including warehouse staff, production supervisors, and quality control personnel.

3. Responsibilities

• Warehouse Staff: Responsible for maintaining accurate inventory records, ensuring proper stock rotation, and conducting regular cycle counts.
• Production Supervisor: Responsible for overseeing stock usage during the production process and ensuring adherence to the FIFO principle.
• Quality Control (QC) Personnel: Responsible for conducting periodic checks to verify the accuracy of inventory records and compliance with this SOP.
• Materials Management Team: Responsible for coordinating with procurement and ensuring timely stock replenishment.

4. Procedure

4.1 Inventory Control:

• Maintain a centralized inventory management system that tracks the movement of pharmaceutical products from receipt to distribution.
• Assign unique identification numbers or codes to each product batch and link them to their corresponding expiry dates.
• Update the inventory records in real-time after each receipt, movement, or usage of products to maintain accuracy.
• Conduct regular cycle counts to verify the physical inventory against the documented records and address any discrepancies promptly.
• Use electronic inventory tracking systems whenever possible to reduce manual errors and improve efficiency.

4.2 Stock Rotation (FIFO Principle):

• Arrange the pharmaceutical products in the warehouse using the FIFO principle, where the oldest stock is placed in front and used first.
• Ensure that the products with the earliest expiry dates are selected and used during the production process.
• During stock replenishment, place newly received batches behind existing stock to maintain the proper rotation.
• Periodically check the warehouse shelves for expired or soon-to-expire products and segregate them for timely disposal.

4.3 Stock Replenishment:

• Coordinate with the materials management team to ensure timely procurement of pharmaceutical products to prevent stock outs.
• Verify the received products against the purchase order and packing list to ensure accuracy and product integrity.
• Update the inventory records to reflect the newly received stock and its corresponding expiry dates.
• Place the newly received stock in the appropriate storage location following the FIFO principle.

5. Abbreviations

SOP: Standard Operating Procedure
FIFO: First-In-First-Out
QC: Quality Control

6. Documents

The following documents are relevant to this SOP:

• Inventory Management System User Manual
• Inventory Records and Cycle Count Logs
• Stock Replenishment and Procurement Procedures

7. References

No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Inventory Control and Stock Rotation, effective as of [Insert Date].

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper storage, organization, and retrieval of tablets in the pharmaceutical manufacturing facility. This SOP ensures that tablets are stored under controlled conditions, easily accessible, and that the correct inventory is maintained at all times.

2. Scope

This SOP applies to all personnel involved in tablet storage and retrieval, including warehouse staff, production operators, and quality control personnel.

3. Responsibilities

• Warehouse Staff: Responsible for the proper storage and organization of tablets in the designated storage area.
• Production Operators: Responsible for requesting the required tablets from the warehouse and returning any unused tablets after the production process.
• Quality Control (QC) Personnel: Responsible for conducting periodic checks on tablet inventory to ensure accuracy and compliance with this SOP.
• Production Supervisor: Responsible for overseeing the tablet storage and retrieval process and addressing any issues or discrepancies.

4. Procedure

4.1 Tablet Storage:

• Store tablets in a dedicated and well-organized storage area, following the first-in-first-out (FIFO) principle to use older batches first.
• Ensure that the storage area is clean, dry, and free from direct sunlight to maintain the tablets’ stability and prevent contamination.
• Use appropriate storage containers, such as sealed bins or containers, to protect the tablets from environmental factors and potential damage.
• Label each storage container with essential information, including the product name, batch number, expiry date, and any other relevant details.
• Maintain proper segregation of different products and batches to prevent cross-contamination.

4.2 Tablet Retrieval:

• Production operators should request the required tablets from the warehouse through a formal request process, providing the necessary details like product name, quantity, and batch number.
• Warehouse staff should verify the request against the available inventory and ensure that the requested tablets meet the required specifications.
• Retrieved tablets should be carefully inspected for any visible defects or damages before being handed over to the production operators.
• Any unused tablets after the production process should be returned to the warehouse promptly and logged back into inventory.

4.3 Inventory Management and Documentation:

• Maintain accurate records of the tablet inventory, including stock levels, batch numbers, and expiry dates.
• Regularly update the inventory records after each receipt, storage, and retrieval of tablets.
• Conduct periodic cycle counts and reconcile the physical inventory with the documented records to identify and correct any discrepancies.
• Keep a log of any damaged or expired tablets and follow appropriate procedures for their disposal.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control
FIFO: First-In-First-Out

6. Documents

The following documents are relevant to this SOP:

• Tablet Storage and Inventory Log
• Tablet Retrieval Request Form
• Tablet Disposal Procedure

7. References

No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Tablet Storage and Retrieval, effective as of [Insert Date].

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper operation and handling of tablet storage equipment to ensure the storage conditions meet the required specifications, prevent contamination, and maintain the quality of the tablets during storage.

2. Scope

This SOP applies to all personnel involved in the operation and handling of tablet storage equipment, including warehouse staff, quality control personnel, and other relevant employees.

3. Responsibilities

• Warehouse Staff: Responsible for operating the tablet storage equipment as per this SOP and ensuring that tablets are stored in the designated areas correctly.
• Quality Control (QC) Personnel: Responsible for conducting regular checks on the storage conditions and ensuring compliance with the required standards.
• Production Supervisor: Responsible for overseeing the tablet storage process and addressing any concerns related to storage and handling.

4. Procedure

4.1 Preparation of Tablet Storage Equipment:

• Before using the tablet storage equipment, ensure that it is clean, sanitized, and free from any residues from previous storage.
• Check the temperature and humidity settings of the storage equipment and ensure that they are calibrated and set to the required storage conditions for the specific tablets.
• Inspect the storage equipment for any physical damages or malfunctions that may affect the storage environment.
• Ensure that the storage area is well-organized, with clear labeling and segregation of different tablet batches.

4.2 Loading and Unloading of Tablets:

• When loading tablets into the storage equipment, handle them with care to prevent breakage or damage.
• Use appropriate containers, such as clean and approved bins or trays, to store the tablets inside the equipment.
• Avoid overloading the storage equipment to maintain proper air circulation and prevent compression or deformation of the tablets.
• Ensure that tablets with different batch numbers or expiry dates are properly segregated and stored separately.
• During unloading, check the tablets for any abnormalities or damages, and report any issues to the production supervisor or QC personnel.

4.3 Monitoring and Maintenance:

• Regularly monitor the storage equipment’s temperature and humidity levels to ensure they remain within the specified range.
• Keep a log of temperature and humidity readings as part of routine monitoring and quality control procedures.
• Perform scheduled maintenance and cleaning of the storage equipment to ensure its proper functioning.
• Address any equipment malfunctions or deviations from the required storage conditions promptly and report them for resolution.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control

6. Documents

The following documents are relevant to this SOP:

• Tablet Storage Equipment Manual
• Storage Area Organization Plan
• Storage Equipment Maintenance and Calibration Log

7. References

No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Operation of Tablet Storage and Handling Equipment, effective as of [Insert Date].

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper handling and rejection of defective tablets identified during the manufacturing or inspection process. This SOP ensures that defective tablets are segregated, properly disposed of, and that appropriate actions are taken to investigate and prevent future occurrences.

2. Scope

This SOP applies to all personnel involved in tablet manufacturing, inspection, and quality control, including operators, inspectors, and quality assurance staff.

3. Responsibilities

• Tablet Manufacturing Operator: Responsible for identifying and segregating defective tablets during the manufacturing process.
• Inspection Equipment Operator: Responsible for identifying defective tablets during the inspection process and initiating the rejection process.
• Quality Control (QC) Inspector: Responsible for verifying and documenting the identification and rejection of defective tablets.
• Production Supervisor: Responsible for overseeing the handling and rejection of defective tablets and ensuring that corrective actions are taken.

4. Procedure

4.1 Identification of Defective Tablets:

• During the tablet manufacturing process, any tablets that do not meet the required quality standards or have defects, such as chipping, cracks, discoloration, or size variation, should be identified and separated from the accepted tablets.
• During the tablet inspection process, any tablets that do not meet the acceptance criteria or are identified as defective by the inspection equipment should be segregated from the accepted tablets.
• Defective tablets should be clearly labeled as “Rejected” and not mixed with accepted tablets to prevent any unintentional use or distribution.

4.2 Rejection and Disposal of Defective Tablets:

• Once defective tablets are identified and segregated, they should be placed in designated rejection containers or bins.
• Ensure that the rejection containers are properly sealed or covered to prevent any cross-contamination or accidental use.
• Properly dispose of the rejected tablets following the company’s waste disposal procedures and regulatory guidelines.
• Document the quantity and reason for rejection in the appropriate production or inspection records.

4.3 Investigation and Corrective Actions:

• When defective tablets are identified, conduct an investigation to determine the root cause of the defects.
• Involve relevant personnel, such as operators, inspectors, and quality assurance staff, in the investigation process to gather insights and data.
• Implement corrective actions to address the root cause and prevent the recurrence of similar defects in future batches.
• Document the investigation findings and corrective actions taken for future reference.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control

6. Documents

The following documents are relevant to this SOP:

• Batch Records for the tablets being manufactured or inspected
• Rejection Log for Defective Tablets
• Investigation and Corrective Action Report

7. References

No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Handling and Rejection of Defective Tablets, effective as of [Insert Date].