Standard Operating Procedure for Quality Control Testing of Powders

1) Purpose

The purpose of this SOP is to provide a standardized procedure for the quality control testing of powders 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 powders 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

1. 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.
2. Physical Tests:
   1. Appearance:
      1. Inspect the powder 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.
3. Chemical Tests:
   1. Assay of Active Ingredient:
      1. Perform assay using an appropriate analytical method (e.g., HPLC, UV