Standard Operating Procedure for Handling and Rejection of Defective Tablets

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].