Standard Operating Procedure for Preservative Content Testing in Creams
1) Purpose
The purpose of this SOP is to define procedures for conducting preservative content testing on creams. This ensures that creams contain adequate levels of preservatives to maintain microbiological quality throughout their shelf life.
2) Scope
This SOP applies to the Quality Control Department and personnel responsible for conducting preservative content testing of creams. It covers testing methods, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Quality Control Manager is responsible for overseeing preservative content testing activities. The Quality Control Team and Testing Technicians are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Sampling
4.1.1 Select representative samples of creams from the batch for testing.
4.1.2 Ensure samples are taken aseptically and in accordance with sampling plans.
4.1.3 Label each sample with batch information and identification numbers.
4.2 Sample Preparation
4.2.1 Prepare cream samples for preservative content testing according to validated extraction or dilution methods.
4.2.2 Ensure samples are handled under aseptic conditions to avoid contamination.
4.3 Testing Method
4.3.1 Perform preservative content testing using validated analytical methods such as high-performance liquid chromatography (HPLC) or spectrophotometry.
4.3.2 Follow compendial or company-specific procedures for preservative content testing.
4.4 Calculation
4.4.1 Calculate the concentration of preservatives in the cream samples
4.4.2 Ensure calculations are accurate and repeatable.
4.5 Acceptance Criteria
4.5.1 Establish acceptance criteria for preservative content based on regulatory requirements, pharmacopeial standards, and product specifications.
4.5.2 Compare test results against acceptance criteria to determine compliance with specified preservative levels.
4.6 Documentation and Reporting
4.6.1 Document all preservative content testing activities, including sample preparation, testing methods, procedures, results, and observations.
4.6.2 Prepare preservative content testing reports summarizing test conditions, results, conclusions, and recommendations.
4.6.3 Obtain approval from Quality Control Management for preservative content testing reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
HPLC: High-Performance Liquid Chromatography
6) Documents, if any
Preservative Content Testing Protocols
Preservative Content Testing Reports
Non-Conforming Material Reports
7) Reference, if any
USP : General chapters related to preservative testing of pharmaceutical products
Company-specific analytical testing procedures
8) SOP Version
Version 1.0