Standard Operating Procedure for Handling of Rejected Vials

1) Purpose

The purpose of this SOP is to define the procedures for handling and disposing of rejected vials to prevent contamination and ensure regulatory compliance.

2) Scope

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

3) Responsibilities

The responsibilities of this SOP include:
– Production Operators: Identifying and segregating rejected vials.
– Quality Control (QC) Department: Verifying the rejection criteria and conducting necessary tests.
– Quality Assurance (QA) Department: Reviewing and approving handling procedures and records.

4) Procedure

4.1 Identification of Rejected Vials
4.1.1 Identify vials that do not meet quality standards during inspection or testing.
4.1.2 Mark the rejected vials clearly with a rejection label.
4.2 Segregation of Rejected Vials
4.2.1 Immediately remove rejected vials from the production line.
4.2.2 Place rejected vials in a designated rejection bin or area to prevent mix-up with acceptable products.
4.3 Documentation of Rejected Vials
4.3.1 Record the batch number, quantity, and reason for rejection in the rejection log.
4.3.2 Ensure the rejection log is signed and dated by the responsible personnel.
4.4 Investigation of Rejected Vials
4.4.1 Conduct an investigation to determine the cause of rejection.
4.4.2 Record the investigation findings and any corrective actions taken.
4.4.3 Implement corrective and preventive actions (CAPA) to prevent recurrence of the issue.
4.5 Disposal of Rejected Vials
4.5.1 Dispose of rejected vials according to the company’s waste disposal procedures.
4.5.2 Ensure that disposal is carried out in compliance with environmental and regulatory guidelines.
4.6 Documentation
4.6.1 Maintain records of all rejected vials, including identification, segregation, investigation, and disposal.
4.6.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Rejection Log
– Investigation Reports
– Disposal Records

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Environmental and Regulatory Guidelines

8) SOP Version

Version 1.0