Standard Operating Procedure for Tablet Thickness Sorting Process
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a robust and consistent method for the Tablet Thickness Sorting Process. This procedure ensures that all tablets produced meet the required thickness specifications and maintain high-quality standards throughout the pharmaceutical manufacturing process. By adhering to this SOP, we can enhance product reliability, patient safety, and compliance with relevant regulations.
Scope
This SOP applies to all personnel involved in the Tablet Thickness Sorting Process at [Pharmaceutical Company Name]. It encompasses the sorting of tablets across all manufacturing batches, covering both immediate-release and controlled-release formulations. The SOP outlines the step-by-step process from tablet loading to inspection and aims to maintain a reliable and efficient sorting operation.
Responsibilities
The success of this SOP relies on the cooperation and dedication of various personnel:
- Quality Assurance Department: Responsible for creating, reviewing, and approving this SOP. They shall also perform periodic audits to verify compliance with the procedure.
- Production Operators: Responsible for executing the Tablet Thickness Sorting Process as per the guidelines outlined in this SOP. They must ensure accuracy, efficiency, and adherence to safety protocols.
- Quality Control Team: Responsible for inspecting sorted tablets, verifying their compliance with thickness specifications, and conducting appropriate quality checks.
- Manufacturing Supervisors: Responsible for overseeing the entire sorting 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 Thickness Sorting Process:
- Preparation:
- Ensure that the Tablet Thickness Sorter is clean and calibrated before initiating the sorting process.
- Verify that the sorting parameters are correctly set based on the tablet specifications provided in the manufacturing instructions.
- Perform a visual inspection of the sorting trays to ensure they are free from any residues or contaminants.
- Tablet Loading:
- Carefully load the pre-checked tablets into the sorting trays, taking care not to damage or break any tablets during the process.
- Ensure that the tablets are evenly distributed across the trays to facilitate accurate sorting.
- Sorting Process:
- Start the Tablet Thickness Sorter and allow it to complete the sorting process for the loaded tablets.
- Monitor the sorting operation closely to detect any deviations or abnormalities in the sorting process.
- If any tablets are rejected during the sorting process, segregate them properly for further investigation.
- Quality Inspection:
- Once the sorting process is complete, inspect the sorted tablets according to the quality control requirements.
- Verify that the sorted tablets meet the specified thickness criteria as outlined in the manufacturing instructions.
- If any tablets fail to meet the required specifications, document the deviations and inform the relevant departments for investigation.
- Shutdown and Cleaning:
- Power off the Tablet Thickness Sorter after the completion of the sorting process.
- Thoroughly clean the sorting trays and the equipment to prevent cross-contamination between batches.
- Documentation:
- Record all relevant data, including sorting parameters, inspection results, deviations, and any maintenance activities performed.
- Ensure that all entries are legible, accurate, and signed by the responsible 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 Maintenance Records
- Quality Inspection Checklist
Reference
No external references are used in this SOP.
SOP Version
This is version 1.0 of the SOP for Tablet Thickness Sorting Process, issued on [Date of Issue].