Standard Operating Procedure for Capsule Filling

Purpose

The purpose of this SOP is to establish procedures for the accurate and consistent filling of capsules, ensuring uniformity, cleanliness, and adherence to quality standards.

Scope

This SOP applies to all personnel involved in the capsule filling process, including operators, quality assurance personnel, and supervisors.

Responsibilities

• Operators: Responsible for executing the capsule filling process according to the established procedures.
• Quality Assurance: Responsible for monitoring and ensuring compliance with the capsule filling SOP.
• Supervisors: Responsible for overseeing the capsule filling process and providing necessary support to operators.

Procedure

1. Ensure that the capsule filling machine is clean, sanitized, and calibrated before starting the filling process.
2. Verify that all materials, including empty capsules and the capsule filling powder blend, are properly labeled and approved for use.
3. Inspect the capsules for any damage or defects before loading them into the capsule filling machine.
4. Weigh and dispense the capsule filling powder blend accurately, following Good Manufacturing Practices (GMP) and the approved formulation recipe.
5. Set up the capsule filling machine according to the specifications for capsule size and fill weight.
6. Load the empty capsules into the filling machine and initiate the filling process, ensuring that the powder is evenly distributed among the capsules.
7. Monitor the filling process to identify and address any issues, such as capsule misalignment or overfilling.
8. Perform periodic checks on filled capsules, including weight checks and visual inspections, to ensure uniformity and quality.
9. If adjustments to the filling process are necessary, document the changes made, including any deviations from the standard operating conditions.
10. Collect samples of filled capsules for quality control testing, including dissolution testing and content uniformity.
11. Submit the samples to the quality control laboratory for analysis, ensuring that the capsules meet the predefined acceptance criteria.
12. If the filled capsules pass quality control, proceed with further processing steps as per the formulation requirements.
13. If the filled capsules fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
14. Complete the batch record with all pertinent information, including any adjustments made during the capsule filling process.
15. Clean and sanitize the equipment thoroughly after each batch, following approved cleaning procedures.

Abbreviations

GMP: Good Manufacturing Practices

Documents

• Capsule Filling Batch Record
• Quality Control Test Results
• Cleaning and Sanitization Records

Reference

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

SOP Version

Version 1.0