Standard Operating Procedure for Final Product Inspection for Aerosols
1) Purpose
The purpose of this SOP is to define procedures for conducting final product inspection and release activities for aerosols in the pharmaceutical industry. Final product inspection ensures that finished aerosol products meet specified quality standards before release for distribution.
2) Scope
This SOP applies to the final inspection of all aerosol products manufactured at [Company Name], including finished goods ready for distribution.
3) Responsibilities
Quality Assurance (QA) Personnel: Responsible for conducting final product inspection and release.
Production Operators: Assist in preparing finished products for inspection.
Quality Control (QC) Analysts: Perform testing and evaluation of finished products.
4) Procedure
4.1 Sampling:
4.1.1 Select representative samples from the batch according to sampling plan and procedures.
4.1.2 Ensure samples are handled and transported to the QC laboratory in a manner that preserves sample integrity.
4.2 Visual Inspection:
4.2.1 Conduct visual inspection of aerosol containers for defects, labeling accuracy, and overall appearance.
4.2.2 Document observations and discrepancies found during visual inspection.
4.3 Physical Testing:
4.3.1 Perform physical tests such as leak testing, spray pattern evaluation, and container integrity checks.
4.3.2 Use validated test methods and equipment for physical testing procedures.
4.4 Chemical and Microbiological Testing:
4.4.1 Conduct testing for chemical attributes (e.g., assay, content uniformity) and microbiological attributes (e.g., microbial limits testing) as per specifications.
4.4.2 Follow approved test methods and acceptance criteria for chemical and microbiological testing.
4.5 Compliance Verification:
4.5.1 Compare test results against established acceptance criteria and specifications.
4.5.2 Document results and ensure all testing requirements are met before release decision.
4.6 Release Decision:
4.6.1 Based on inspection and testing results, make a decision to release or reject the batch.
4.6.2 Complete batch documentation and update records to reflect release status.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
6) Documents, if any
Final Product Inspection Records
Test Certificates and Reports
Batch Release Documentation
7) Reference, if any
GMP Guidelines
Pharmacopeial standards (e.g., USP, EP)
8) SOP Version
Version 1.0
