Standard Operating Procedure for Labeling and Packaging Control in Otic Manufacturing Unit
1) Purpose
To establish procedures for controlling labeling and packaging operations in the manufacturing of Otic (Ear) Dosage Forms to ensure accurate labeling, packaging integrity, and compliance with regulatory requirements.
2) Scope
This SOP applies to all labeling and packaging activities within the Otic manufacturing unit, including primary and secondary packaging processes.
3) Responsibilities
Quality Assurance (QA) Department: Responsible for oversight and approval of labeling and packaging activities.
Quality Control (QC) Department: Responsible for inspection and release of labeling and packaging materials.
Production Department: Responsible for executing labeling and packaging operations according to approved procedures.
4) Procedure
4.1 Labeling Control
4.1.1 Label Approval
4.1.1.1 QA reviews and approves labeling artworks and specifications before use.
4.1.1.2 Maintain a master list of approved labeling materials.
4.1.2 Labeling Procedure
4.1.2.1 Verify correct labeling materials and content for each batch.
4.1.2.2 Ensure labeling is accurate, legible, and in accordance with approved specifications.
4.2 Packaging Control
4.2.1 Packaging Material Inspection
4.2.1.1 QC inspects incoming packaging materials for conformity with specifications.
4.2.1.2 Quarantine non-conforming materials and initiate appropriate disposition.
4.2.2 Packaging Procedure
4.2.2.1 Set up packaging equipment as per approved procedures.
4.2.2.2 Verify correct batch and packaging components before initiating packaging operations.
4.3 Line Clearance
4.3.1 Pre-Packaging
4.3.1.1 Conduct line clearance to ensure no mix-ups or contamination from previous batches.
4.3.1.2 Document line clearance activities in the batch record.
4.3.2 Post-Packaging
4.3.2.1 Perform final inspection of packaged units for correctness and integrity.
4.3.2.2 Document results of final inspection and release for distribution.
4.4 Labeling and Packaging Records
4.4.1 Batch Record Documentation
4.4.1.1 Complete labeling and packaging sections of the batch record accurately and contemporaneously.
4.4.1.2 Obtain necessary approvals before batch release.
4.4.2 Documentation Retention
4.4.2.1 Archive all labeling and packaging records as per document retention policies.
4.4.2.2 Ensure records are readily retrievable for regulatory inspections.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
6) Documents, if any
Approved labeling artworks
Packaging material specifications
Batch record template
7) Reference, if any
GMP guidelines for labeling and packaging in pharmaceutical manufacturing
8) SOP Version
Version 1.0
