Standard Operating Procedure for Labeling of Vials

1) Purpose

The purpose of this SOP is to establish procedures for the accurate and consistent labeling of vials to ensure correct identification and traceability of injection products.

2) Scope

This SOP applies to all personnel involved in the labeling of vials at [Company Name] for the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Operators: Performing labeling of vials according to the SOP.
– Quality Assurance (QA) Department: Reviewing and approving labeling procedures and records.

4) Procedure

4.1 Preparation for Labeling
4.1.1 Ensure the labeling area is clean and organized.
4.1.2 Verify that all labeling equipment is clean and in good working condition.
4.1.3 Ensure that labels are printed accurately with the correct information.
4.2 Labeling Process
4.2.1 Set up the labeling equipment according to the manufacturer’s instructions.
4.2.2 Perform a pre-use check to ensure the equipment is functioning correctly.
4.2.3 Place vials on the labeling conveyor or platform.
4.2.4 Operate the labeling machine to apply labels to the vials.
4.2.5 Ensure each vial is labeled accurately and securely.
4.3 Quality Control Checks
4.3.1 Inspect labeled vials to ensure labels are correctly applied and legible.
4.3.2 Perform checks to verify that the correct labels are used for each batch.
4.3.3 Record inspection results and compare them with established acceptance criteria.
4.3.4 If any labels are found to be incorrect or improperly applied, investigate the cause and take corrective actions.
4.4 Shutdown and Cleanup
4.4.1 Once labeling is complete, shut down the equipment according to the manufacturer’s instructions.
4.4.2 Clean and disinfect the labeling equipment and surrounding area.
4.4.3 Perform a post-use check to ensure the equipment is ready for the next operation.
4.5 Documentation
4.5.1 Maintain records of all labeling operations, including setup, quality control checks, and any deviations or corrections.
4.5.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Labeling Operation Records
– Quality Control Inspection Records

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Labeling Equipment Manufacturer’s Manual

8) SOP Version

Version 1.0