Standard Operating Procedure for Mixing and Blending

Purpose

The purpose of this SOP is to establish procedures for the proper mixing and blending of ingredients in the formulation of capsules, ensuring uniformity, consistency, and adherence to quality standards.

Scope

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

Responsibilities

• Formulation Scientist: Responsible for developing the mixing and blending process parameters.
• Operators: Responsible for executing the mixing and blending process according to the established procedures.
• Quality Assurance: Responsible for monitoring and ensuring compliance with the mixing and blending SOP.

Procedure

1. Review the formulation recipe to ensure that all required ingredients and their respective quantities are accurately documented.
2. Verify that all equipment, including mixing vessels, blenders, and tools, is clean, sanitized, and calibrated before initiating the process.
3. Weigh and dispense each ingredient accurately, following Good Manufacturing Practices (GMP) and the approved formulation recipe.
4. Transfer the weighed ingredients to the designated mixing vessel or blender according to the formulation specifications.
5. Initiate the mixing or blending process based on the predefined parameters, including rotation speed, blending time, and any specific instructions for the formulation.
6. Monitor the mixing process to ensure uniform distribution of ingredients and adherence to the specified blending time.
7. Perform in-process checks, such as visual inspections or periodic sampling, to assess the blend’s homogeneity during the blending process.
8. Upon completion of the mixing or blending cycle, collect a representative sample for quality control testing.
9. Document all relevant details, including start and end times, equipment used, and any deviations from the standard operating conditions.
10. Submit the sample to the quality control laboratory for analysis, ensuring that it meets the predefined acceptance criteria.
11. If the blend passes quality control, proceed with further processing steps as per the formulation requirements.
12. If the blend fails quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
13. Complete the batch record with all pertinent information, including any adjustments made during the mixing and blending process.
14. Clean and sanitize the equipment thoroughly after each batch, following approved cleaning procedures.

Abbreviations

GMP: Good Manufacturing Practices

Documents

• Formulation Recipe
• Mixing and Blending 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