Standard Operating Procedure for Granule Preparation

1) Purpose

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

2) Scope

This SOP applies to all personnel involved in the preparation of granules 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 granules meet the required specifications.

4) Procedure

1. Preparation of Equipment:
   1. Ensure all equipment is clean and calibrated.
   2. Verify the availability of raw materials.
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. Mixing:
   1. Transfer the weighed raw materials into the mixing vessel.
   2. Mix the materials for the specified time to ensure homogeneity.
   3. Sample the mixture and perform homogeneity testing.
4. Granulation:
   1. Transfer the mixed powder to the granulation equipment.
   2. Granulate the mixture using the specified method (wet or dry granulation).
   3. Monitor the granulation process parameters to ensure consistency.
5. Drying:
   1. Transfer the wet granules to the drying equipment.
   2. Dry the granules to the specified moisture content.
   3. Sample the granules and perform moisture content testing.
6. Sieving:
   1. Pass the dried granules through the appropriate sieve to achieve the desired particle size distribution.
   2. Collect and label the sieved granules.
7. Packaging:
   1. Transfer the sieved granules into appropriate packaging containers.
   2. Label the containers with relevant information such as batch number and manufacturing date.

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