Standard Operating Procedure for Finished Product Testing for Gels
1) Purpose
The purpose of this SOP is to define procedures for conducting finished product testing on gels to ensure they meet quality specifications before distribution to customers.
2) Scope
This SOP applies to the Quality Control (QC) department responsible for performing finished product testing on gels manufactured at the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC): Perform finished product testing according to defined procedures and standards.
Quality Assurance (QA): Oversee the implementation of finished product testing procedures and ensure compliance with SOPs and regulatory guidelines.
Production: Provide samples for finished product testing and coordinate with QC for timely testing.
4) Procedure
4.1 Sample Collection
4.1.1 Collect representative samples from finished gel batches with documented batch/lot numbers and production records.
4.1.2 Ensure samples are labeled correctly and securely stored prior to testing.
4.2 Initial Inspection
4.2.1 Conduct visual inspection of samples for any signs of contamination, defects, or deviations from specifications.
4.2.2 Record observations and document initial inspection findings.
4.3 Physical Testing
4.3.1 Perform physical tests according to predefined specifications, including:
a) Appearance: Assess color, clarity, and consistency.
b) pH Testing: Measure pH using calibrated equipment.
c) Viscosity Testing: Determine viscosity using appropriate methods.
d) Homogeneity Testing: Verify uniform distribution of components.
4.4 Chemical Testing
4.4.1 Conduct chemical analysis to ensure active ingredient content meets specified limits.
4.4.2 Perform assay testing and evaluate results against acceptance criteria.
4.5 Microbiological Testing
4.5.1 Perform microbial limits testing to ensure gel batches meet microbiological safety standards.
4.5.2 Conduct sterility testing where applicable to verify absence of microbial contamination.
4.6 Packaging Integrity
4.6.1 Inspect packaging materials and containers for integrity and compliance with specifications.
4.6.2 Conduct leak testing of gel tubes and containers to ensure proper sealing.
4.7 Compliance Assessment
4.7.1 Compare test results against predefined acceptance criteria and specifications.
4.7.2 Document compliance or non-compliance with testing requirements.
4.8 Reporting and Documentation
4.8.1 Prepare detailed test reports documenting test results, compliance status, and any deviations.
4.8.2 Maintain accurate records of all finished product 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
– Finished Product Testing Protocols and Procedures
– Test Reports and Data Sheets
– Batch Production Records and Documentation
7) Reference, if any
– Current Good Manufacturing Practices (cGMP) regulations
– Pharmacopoeial monographs (e.g., USP, Ph. Eur.) on finished product testing requirements
– Company-specific quality assurance standards and guidelines
8) SOP Version
Version 1.0