SOP for Quality Control Testing of Granules

Standard Operating Procedure for Quality Control Testing of Granules

1) Purpose

The purpose of this SOP is to provide a standardized procedure for the quality control testing of granules in the pharmaceutical manufacturing process to ensure they meet the required specifications for safety, efficacy, and quality.

2) Scope

This SOP applies to all quality control personnel involved in testing granules within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control Analysts: Responsible for performing all tests according to the SOP and recording results accurately.
Quality Control Supervisors: Responsible for reviewing test results and ensuring compliance with the SOP.
Laboratory Technicians: Responsible for maintaining and calibrating testing equipment.

4) Procedure

Sample Collection:
1. Collect samples from different locations within the batch to ensure representativeness.
2. Label samples with batch number, date, and other relevant information.
Physical Tests:
1. Appearance:
  1. Inspect the granules for color, texture, and uniformity.
  2. Record any deviations from the standard.
2. Particle Size Distribution:
  1. Perform sieve analysis or laser diffraction to determine particle size distribution.
  2. Record the particle size distribution data.
3. Bulk Density:
  1. Measure the bulk density using the appropriate method (e.g., tapped density apparatus).
  2. Record the bulk density value.
4. Moisture Content:
  1. Determine moisture content using a moisture analyzer or Karl Fischer titration.
  2. Record the moisture content.
5. Friability:
  1. Test the friability of the granules using a friabilator.
  2. Record the percentage of weight loss

after the test.

Chemical Tests:

Assay of Active Ingredient:
1. Perform assay using an appropriate analytical method (e.g., HPLC, UV spectrophotometry).
2. Calculate and record the concentration of the active ingredient.
Impurity Testing:
1. Conduct tests for specified impurities using validated methods.
2. Record the results and ensure they are within acceptable limits.

Microbial Tests:

Perform microbial testing to ensure the granules meet microbiological standards.
Record the results of microbial tests.

Data Analysis and Reporting:

Analyze the test results and compare them with the product specifications.
Document the findings in the quality control report.
Submit the report to the quality control supervisor for review.

Review and Approval:

Quality control supervisor reviews the report and test results.
Approve or reject the batch based on the test results and product specifications.

5) Abbreviations, if any

HPLC: High-Performance Liquid Chromatography

6) Documents, if any

Quality Control Report, Batch Manufacturing Record (BMR)

7) Reference, if any

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

8) SOP Version

Version 1.0