Standard Operating Procedure for Specific Gravity Testing in Creams
1) Purpose
The purpose of this SOP is to define procedures for conducting specific gravity testing on creams. This ensures accurate determination of the density of creams, which is critical for quality control and formulation consistency.
2) Scope
This SOP applies to the Quality Control Department and personnel responsible for conducting specific gravity testing of creams. It covers testing methods, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Quality Control Manager is responsible for overseeing specific gravity 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 specific gravity testing by ensuring they are thoroughly mixed and free of air bubbles.
4.2.2 Ensure samples are at specified temperature conditions for accurate testing.
4.3 Testing Method
4.3.1 Measure the mass of an empty and clean specific gravity bottle.
4.3.2 Fill the specific gravity bottle with cream sample, ensuring it’s completely filled and free of air bubbles.
4.3.3 Weigh the
4.4 Calculation
4.4.1 Calculate the specific gravity of the cream sample using the formula:
Specific Gravity = (Mass of cream-filled bottle / Mass of empty bottle) / Density of water at testing temperature.
4.4.2 Perform calculations with accuracy and ensure units are consistent.
4.5 Acceptance Criteria
4.5.1 Establish acceptance criteria for specific gravity based on product specifications and formulation requirements.
4.5.2 Compare test results against acceptance criteria to determine compliance with specified specific gravity values.
4.6 Documentation and Reporting
4.6.1 Document all specific gravity testing activities, including sample preparation, testing methods, procedures, results, and observations.
4.6.2 Prepare specific gravity testing reports summarizing test conditions, results, conclusions, and recommendations.
4.6.3 Obtain approval from Quality Control Management for specific gravity testing reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
Specific Gravity Testing Protocols
Specific Gravity Testing Reports
Non-Conforming Material Reports
7) Reference, if any
USP : General chapters related to specific gravity testing of pharmaceutical products
Company-specific testing procedures for specific gravity
8) SOP Version
Version 1.0