Standard Operating Procedure for Quality Control Testing in Lotion Manufacturing

1) Purpose

The purpose of this SOP is to establish the procedure for performing quality control (QC) testing on lotions to ensure that they meet predefined quality standards and specifications.

2) Scope

This SOP applies to all QC personnel involved in testing lotions in the pharmaceutical manufacturing facility, covering all required tests to confirm product quality.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

QC Analysts:

• Conduct QC tests according to this SOP and document results accurately.
• Ensure all testing equipment is calibrated and functioning properly.

QC Supervisors:

• Review and verify test results for accuracy and compliance with specifications.
• Address any deviations or out-of-specification results appropriately.

Production Managers:

• Ensure that QC testing is integrated into the production schedule and that samples are provided on time.

4) Procedure

4.1 Sample Collection:

• Collect samples from the production batch as per the sampling plan.
• Label the samples with batch number, date, and time of collection.

4.2 Physical Tests:

1. Appearance: Inspect the lotion for color, consistency, and absence of visible particulates.
2. Viscosity: Measure the viscosity using a viscometer and record the readings.
3. pH: Determine the pH of the lotion using a calibrated pH meter.

4.3 Chemical Tests:

1. Assay of Active Ingredient: Perform an assay to quantify the active ingredient using HPLC or other suitable analytical techniques.
2. Preservative Content: Analyze the concentration of preservatives to ensure they are within specified limits.

4.4 Microbiological Tests:

1. Total Aerobic Microbial Count: Perform microbial limit tests to determine the total aerobic microbial count.
2. Pathogen Testing: Test for the presence of specified pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans.

4.5 Stability Testing:

• Conduct stability tests to evaluate the product’s shelf life under different storage conditions.

4.6 Documentation:

• Record all test results in the QC logbook and in the batch record.
• Ensure all deviations are documented and investigated promptly.

5) Abbreviations, if any

HPLC: High-Performance Liquid Chromatography

6) Documents, if any

• Quality Control Logbook
• Batch Record
• Standard Test Procedures (STPs)

7) Reference, if any

• ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
• Pharmacopoeia guidelines (USP, EP, JP)

8) SOP Version

Version 1.0