Standard Operating Procedure for Label Control and Accountability
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for controlling and maintaining accountability of labels used in pharmaceutical manufacturing to ensure accurate labeling of products.
2) Scope
This SOP applies to all personnel involved in the handling, issuance, and reconciliation of labels within the pharmaceutical manufacturing facility. It covers procedures for label design, printing, issuance, reconciliation, and destruction.
3) Responsibilities (continued)
– Quality Assurance (QA) Department: Ensures compliance with label control SOP and regulatory requirements.
– Quality Control (QC) Department: Verifies label accuracy and performs label reconciliation.
– Production Department: Responsible for labeling operations and ensuring correct label application.
4) Procedure
4.1 Label Design and Approval
4.1.1 Develop label templates that include all required information such as product name, strength, batch number, and expiration date.
4.1.2 Obtain approval from QA for label design and ensure compliance with regulatory requirements.
4.2 Label Printing and Issuance
4.2.1 Print labels using validated printers and label materials suitable for pharmaceutical use.
4.2.2 Issue labels to production personnel based on batch-specific requirements and document issuance details.
4.3 Label Application
4.3.1 Apply labels to products immediately after printing to minimize risk of mix-up or
4.3.2 Verify correct label application and adherence to product packaging in accordance with SOP.
4.4 Label Reconciliation
4.4.1 Maintain accurate records of label issuance, usage, and reconciliation throughout production.
4.4.2 Perform regular reconciliations to ensure all labels are accounted for and accounted properly.
4.5 Label Destruction
4.5.1 Dispose of unused or obsolete labels in a secure manner to prevent unauthorized use.
4.5.2 Document label destruction activities and maintain records for audit trail purposes.
4.6 Documentation
4.6.1 Document all aspects of label control and accountability, including label designs, issuance records, reconciliation reports, and destruction logs.
4.6.2 Ensure that all records are reviewed and approved by the QA department.
4.7 Reporting
4.7.1 Prepare a label control report summarizing label issuance, reconciliation results, and any discrepancies identified.
4.7.2 Submit the report to the QA department for review and approval.
4.8 Corrective Actions
4.8.1 Investigate and address any deviations or non-conformities related to label control and accountability.
4.8.2 Implement corrective actions to improve label control processes and prevent recurrence of issues.
5) Abbreviations, if any
– QA: Quality Assurance
– QC: Quality Control
– SOP: Standard Operating Procedure
6) Documents, if any
– Label Templates
– Label Issuance Records
– Label Reconciliation Reports
7) Reference, if any
– FDA Guidance for Industry: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements
– EU GMP Annex 13: Manufacture of Investigational Medicinal Products
8) SOP Version
Version 1.0