Standard Operating Procedure for Specific Gravity Testing in Gels
1) Purpose
The purpose of this SOP is to define procedures for determining the specific gravity of gels to ensure consistency and quality.
2) Scope
This SOP applies to the Quality Control (QC) department responsible for performing specific gravity testing on gels manufactured at the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC): Perform specific gravity testing according to defined procedures and standards.
Quality Assurance (QA): Oversee the implementation of specific gravity testing procedures and ensure compliance with SOPs and regulatory guidelines.
R&D or Formulation Development: Provide formulation details and method validation support for specific gravity testing.
4) Procedure
4.1 Sample Collection and Preparation
4.1.1 Collect representative samples from finished gel batches with documented batch/lot numbers and production records.
4.1.2 Prepare samples as per SOP to ensure uniformity and accuracy in specific gravity testing.
4.2 Specific Gravity Measurement
4.2.1 Calibrate the specific gravity measuring device using standard calibration weights or solutions.
4.2.2 Place the prepared sample on the specific gravity meter and record the measurement according to instrument specifications.
4.2.3 Repeat the measurement for accuracy and consistency.
4.3 Interpretation of Results
4.3.1 Compare specific gravity measurement against specified acceptance criteria and product specifications.
4.3.2 Document specific gravity values for each tested sample.
4.4 Compliance Assessment
4.4.1 Evaluate specific gravity results for compliance with company-defined quality standards.
4.4.2 Document compliance or non-compliance with specific gravity specifications.
4.5 Reporting and Documentation
4.5.1 Prepare detailed test reports documenting specific gravity results, compliance status, and any deviations.
4.5.2 Maintain accurate records of all specific gravity testing activities, including protocols, data sheets, and reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Specific Gravity Testing Protocols and Procedures
– Calibration Reports for Specific Gravity Meter
– Test Reports and Data Sheets
7) Reference, if any
– Pharmacopoeial monographs (e.g., USP, Ph. Eur.) on specific gravity testing requirements
– Company-specific quality control guidelines
8) SOP Version
Version 1.0