1) SOP for Sorting Capsules

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for sorting capsules by size, color, and defects to ensure product uniformity and quality.

3) Scope

This SOP applies to all personnel involved in the sorting of capsules within the pharmaceutical manufacturing area.

4) Responsibilities

• Operators are responsible for performing the sorting of capsules according to this SOP.
• Supervisors are responsible for overseeing the sorting process and ensuring compliance.
• Quality Assurance (QA) personnel are responsible for verifying that sorting procedures are followed correctly and addressing any deviations.

5) Procedure

1. Preparation
   1. Ensure the sorting area is clean and free of contaminants.
   2. Verify the availability of sorting tools and equipment (e.g., sieves, color sorters).
   3. Check the cleanliness and readiness of the sorting equipment.
2. Sorting Process
   1. Collect a batch of capsules to be sorted as per the batch record.
   2. Sort the capsules by size using appropriate sieves or sorting machines.
   3. Sort the capsules by color using color sorting machines or manual methods.
   4. Identify and segregate defective capsules (e.g., broken, discolored) and document the type and number of defects observed.
   5. Ensure that the sorted capsules meet the specified quality criteria.
3. Documentation and Reporting
   1. Ensure all sorting results are accurately recorded in the appropriate documentation.
   2. Report any significant findings to the supervisor and QA personnel immediately.
   3. Maintain all sorting records for traceability and compliance purposes.
4. Cleaning and Maintenance
   1. Clean the sorting area and tools after completing the sorting process.
   2. Document the cleaning process in the cleaning logbook.
   3. Perform regular maintenance checks on sorting tools and equipment.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Sorting Logbook
• Batch Record
• Cleaning Logbook

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Manufacturer’s operation and maintenance manual

9) SOP Version

Version 1.0