Standard Operating Procedure for Powder Blending

1) Purpose

The purpose of this SOP is to provide a standardized procedure for the blending of powders in the pharmaceutical manufacturing process to ensure uniformity, quality, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the blending of powders within the pharmaceutical manufacturing facility, including operators, supervisors, and quality control personnel.

3) Responsibilities

Operators: Responsible for following the SOP and ensuring all steps are accurately performed.
Supervisors: Responsible for overseeing the process and ensuring compliance with the SOP.
Quality Control: Responsible for verifying that the blended powders meet the required specifications.

4) Procedure

1. Preparation of Equipment:
   1. Ensure all blending equipment is clean, calibrated, and ready for use.
   2. Verify the availability and quality of raw materials to be blended.
2. Weighing of Raw Materials:
   1. Weigh the required quantities of each raw material using a calibrated balance.
   2. Record the weights in the batch manufacturing record (BMR).
3. Loading the Blender:
   1. Transfer the weighed raw materials into the blender.
   2. Ensure even distribution of materials within the blender.
4. Blending Process:
   1. Set the blender to the required speed and blending time as per the batch record.
   2. Start the blender and monitor the process to ensure proper mixing.
   3. At the end of the blending cycle, stop the blender and check for uniformity.
5. Sampling and Testing:
   1. Collect samples from different locations within the blender to test for homogeneity.
   2. Perform necessary quality control tests to ensure the blend meets specifications.
6. Unloading the Blender:
   1. Once uniformity is confirmed, unload the blended powder into appropriate containers.
   2. Label the containers with relevant information such as batch number and manufacturing date.
7. Cleaning:
   1. Clean the blending equipment as per the cleaning SOP to prevent cross-contamination.

5) Abbreviations, if any

BMR: Batch Manufacturing Record

6) Documents, if any

Batch Manufacturing Record (BMR)

7) Reference, if any

Regulatory guidelines as per FDA, EMA, and other relevant authorities.

8) SOP Version

Version 1.0