Procedures for Blending Capsules to Ensure Content Uniformity

1) Purpose

The purpose of this SOP is to provide guidelines for the blending operation of capsules to ensure content uniformity of the active ingredient.

2) Scope

This SOP applies to all blending operations performed within the pharmaceutical manufacturing facility.

3) Responsibilities

The Production department is responsible for performing blending operations. The Quality Control (QC) department is responsible for verifying content uniformity.

4) Procedure

1. Preparation for Blending:
   1. Ensure all blending equipment is clean and calibrated.
   2. Verify that the raw materials are within the specified acceptance criteria before blending.
2. Blending Process:
   1. Load the raw materials into the blender according to the batch record instructions.
   2. Set the blending parameters (e.g., time, speed) as specified in the batch record.
   3. Start the blending operation and monitor the process to ensure consistency.
3. Sampling During Blending:
   1. Periodically take samples from the blender to check for content uniformity.
   2. Analyze the samples to ensure they meet the specified content uniformity criteria.
4. Post-Blending Actions:
   1. Unload the blended material and transfer it to the next stage of production or packaging.
   2. Document the blending operation details in the batch record, including any deviations and corrective actions.
5. Documentation and Review:
   1. Maintain records of all blending operations in the batch record and blending logbook.
   2. Periodically review blending procedures and parameters to ensure ongoing content uniformity.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Batch Record, Blending Logbook, and Content Uniformity Test Results

7) Reference, if any

Relevant regulatory guidelines such as ICH Q7 and FDA Guidance for Industry

8) SOP Version

Version 1.0