Standard Operating Procedure for Tablet Polishing Process

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized and efficient method for the Tablet Polishing Process. The tablet polishing step is a critical aspect of the pharmaceutical manufacturing process, as it ensures the tablets’ appearance, removes any surface defects, and enhances their visual appeal. By following this SOP, we can maintain consistent tablet quality, improve customer satisfaction, and comply with relevant quality standards and regulations.

Scope

This SOP applies to all personnel involved in the Tablet Polishing Process at [Pharmaceutical Company Name]. It encompasses the polishing of tablets produced across different manufacturing batches and formulations, including both immediate-release and controlled-release tablets. The SOP outlines the step-by-step procedure to be followed and the necessary documentation to ensure the tablet polishing process is conducted effectively and efficiently.

Responsibilities

The successful execution of this SOP requires clear responsibilities from the following personnel:

• Quality Assurance Department: Responsible for developing, reviewing, and approving this SOP. They shall also perform periodic audits to ensure compliance and the effectiveness of the tablet polishing process.
• Production Operators: Responsible for executing the Tablet Polishing Process as per the guidelines outlined in this SOP. They must ensure accuracy, efficiency, and adherence to safety protocols.
• Quality Control Team: Responsible for conducting inspections on polished tablets, verifying their compliance with quality standards, and conducting relevant quality checks.
• Manufacturing Supervisors: Responsible for overseeing the entire polishing process, providing necessary support to operators, and escalating any concerns to the relevant departments.

Procedure

The following step-by-step procedure must be followed during the Tablet Polishing Process:

1. Preparation:
   • Ensure that the Tablet Polishing Machine is clean and calibrated before initiating the polishing process.
   • Verify that the polishing parameters, such as speed and pressure, are set as per the approved manufacturing instructions.
   • Perform a visual inspection of the polishing machine and polishing pads to ensure they are free from any residues or contaminants.
2. Tablet Loading:
   • Carefully load the pre-checked tablets into the polishing machine’s feeding tray, taking care not to damage or break any tablets during the process.
   • Ensure that the tablets are evenly distributed across the polishing pads to facilitate uniform polishing.
3. Polishing Process:
   • Start the Tablet Polishing Machine and allow it to complete the polishing process for the loaded tablets.
   • Monitor the polishing operation closely to detect any deviations or abnormalities in the process.
   • Regularly inspect the polished tablets to ensure they meet the required visual appearance standards.
   • If any tablets are found with surface defects or deviations, segregate them properly for further investigation.
4. Inspection and Sampling:
   • Once the polishing process is complete, inspect a representative sample of the polished tablets to verify their appearance and quality.
   • Conduct any necessary quality checks to ensure the polished tablets meet the required specifications.
   • Record all inspection and sampling data in the batch record and other relevant documentation.
5. Shutdown and Cleaning:
   • Power off the Tablet Polishing Machine after the completion of the polishing process.
   • Thoroughly clean the polishing machine and polishing pads to prevent any cross-contamination between batches.
6. Documentation:
   • Record all relevant data related to the polishing process, including any deviations, inspections, and cleaning activities.
   • Ensure that all entries are clear, accurate, and signed by the respective personnel.

Abbreviations

No abbreviations are used in this SOP.

Documents

The following documents are referenced in this SOP:

• Manufacturing Instructions for Tablet Production
• Equipment Calibration Records
• Equipment Cleaning Records
• Batch Record

Reference

No external references are used in this SOP.

SOP Version

This is version 1.0 of the SOP for Tablet Polishing Process, issued on [Date of Issue].