SOP on Labeling and Packaging Material

1.0 Purpose: This SOP describes the guidelines for designing and approving labeling and packaging material.

2.0 Scope: This SOP applies to Quality Assurance staff.

3.0 Responsibility: Quality Assurance Manager to ensure that the procedure is followed.

4.0 Materials and Equipment: As required.

5.0 Procedure: Labels and labeling errors have been the most frequent reason for product recall. The effective control of printed labeling (labels, inserts, cartons, foils) commences before materials are ordered. For new or changed labeling the following procedure is followed – 

5.1 The Quality Assurance Manager is authorized to review and approve the copy.

5.2 The voluntary changes are related to the depletion of inventories of existing labeling.

5.3 When the labeling in question is interrelated with any other labeling , e.g. inserts & cartons, requires amendment to all of the packaging materials to be used for the packing of a  particular product.

5.4 The changes meet all legal and regulatory requirements.

5.5 Checked to confirm grammatical correctness and absence of typographic and print errors or omissions.

5.6 The medical claims, warnings, dosage are correct.

5.7 Printed text or artwork is as previously approved.

5.8 Design to avoid look-alike labeling.