Standard Operating Procedure for Finished Product Release in Otic Manufacturing Unit
1) Purpose
To establish procedures for the release of finished Otic (Ear) Dosage Forms products, ensuring they meet all quality, safety, and regulatory requirements before distribution.
2) Scope
This SOP applies to the final inspection, testing, and release of finished Otic (Ear) Dosage Forms products within the manufacturing unit.
3) Responsibilities
Quality Assurance (QA) Department: Responsible for final product release based on compliance with approved specifications and regulatory requirements.
Quality Control (QC) Department: Responsible for conducting final testing and inspection to verify product quality.
Production Department: Responsible for completing manufacturing processes according to approved procedures and batch records.
4) Procedure
4.1 Final Inspection and Testing
4.1.1 Sampling
4.1.1.1 QC samples finished products according to sampling plan.
4.1.1.2 Transfer samples to QC laboratory for testing.
4.1.2 Testing
4.1.2.1 Perform testing as per approved specifications (e.g., identity, strength, purity, uniformity).
4.1.2.2 Record and review test results for compliance with acceptance criteria.
4.2 Product Release Decision
4.2.1 Review of Test Results
4.2.1.1 QA reviews all testing data and documentation.
4.2.2 Decision Making
4.2.2.1 QA makes the final decision regarding product release based on test results and compliance assessment.
4.2.2.2 Approve or reject product release based on findings.
4.3 Release Documentation
4.3.1 Batch Record Review
4.3.1.1 QA reviews and approves batch records for completeness and accuracy.
4.3.1.2 Ensure all required documentation is attached and verified.
4.3.2 Labeling and Packaging Check
4.3.2.1 Verify labeling and packaging conformity with approved specifications.
4.3.2.2 Confirm correct batch information and expiry dates.
4.4 Product Release
4.4.1 Final Approval
4.4.1.1 QA authorizes the release of finished products for distribution.
4.4.1.2 Generate and attach release documentation (e.g., Certificate of Analysis).
4.4.2 Batch Release Notification
4.4.2.1 Notify relevant departments of batch release status.
4.4.2.2 Initiate shipping or distribution activities as applicable.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
6) Documents, if any
Batch record
Certificate of Analysis template
Product release checklist
7) Reference, if any
GMP guidelines for finished product release in pharmaceutical manufacturing
8) SOP Version
Version 1.0
