Standard Operating Procedure for Visual Inspection of Packaging Materials
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the visual inspection of packaging materials used in pharmaceutical manufacturing to ensure compliance with quality standards and regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the visual inspection of packaging materials within the pharmaceutical manufacturing facility. It covers procedures for inspection criteria, methods, documentation, and acceptance criteria.
3) Responsibilities
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Quality Control (QC) Department: Performs visual inspections and approves packaging materials for use.
– Procurement Department: Responsible for receiving and storing packaging materials in controlled conditions.
4) Procedure
4.1 Inspection Criteria
4.1.1 Define visual inspection criteria for packaging materials, including cleanliness, dimensions, and surface defects.
4.1.2 Obtain reference samples or standards to assist inspectors in evaluating packaging material quality.
4.2 Inspection Methods
4.2.1 Conduct visual inspections under controlled lighting conditions to enhance detection of defects.
4.2.2 Use magnification tools or other inspection aids as necessary to facilitate thorough examination.
4.3 Acceptance Criteria
4.3.1 Compare inspected packaging materials against predefined acceptance criteria and specifications.
4.3.2 Reject materials that do not meet acceptance
4.4 Documentation
4.4.1 Document all visual inspection activities, including inspection results, deviations, and final disposition.
4.4.2 Ensure that all records are reviewed and approved by the QA department.
4.5 Reporting
4.5.1 Prepare a visual inspection report summarizing inspection findings, acceptance decisions, and any corrective actions taken.
4.5.2 Submit the report to the QA department for review and approval.
4.6 Corrective Actions
4.6.1 Investigate and address any deviations or non-conformities identified during visual inspection.
4.6.2 Implement corrective actions to prevent recurrence of packaging material quality issues.
5) Abbreviations, if any
– QA: Quality Assurance
– QC: Quality Control
– SOP: Standard Operating Procedure
6) Documents, if any
– Visual Inspection Records
– Non-Conformance Reports
– Reference Samples or Standards
7) Reference, if any
– USP General Chapter <790> Visual Inspection of Injections
– ISO 11607-1:2019 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging systems
8) SOP Version
Version 1.0