SOP on Examination and Usage Criteria of Packaging Materials
1.0 Purpose: This SOP describes the guidelines for the examination and usage criteria for packaging materials.
2.0 Scope: This SOP applies to Stores Staff and Quality Control staff.
3.0 Responsibility: Senior Production Chemist to ensure that the procedure is followed.
4.0 Materials and Equipment: As required.
5.1 There are written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and / or testing of labeling and packaging materials are followed.
5.2 A representative sample, labeling and packaging materials, is drawn and examined or tested upon receipt and before use in packaging or labeling of a drug product.
5.3 Any labeling or packing materials meeting appropriate written specifications are approved and released for use. Any labeling and packaging materials that do not meet specifications are rejected to prevent their use in operations for which they are unsuitable.
5.4 Records are maintained for each shipment received of each different labeling and packaging material indicating receipt, examination or testing, and whether accepted or rejected.
5.5 Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents are stored separately with suitable identification. Access to the storage area is limited to authorized personnel.
5.6 Obsolete and outdated labels, labeling, and other packaging materials are destroyed.
5.7 Use of gang-printed labeling for different drug products, or different strengths or net contents of the same drug product, is prohibited.
5.8 When cut labeling is used, packaging and labeling operations, one of the following special control procedures is followed:
5.8.1 Dedication of labeling and packaging lines to each different strength of each different drug product; or
5.8.2 Visual examination to conduct a 100% examination for correct labeling during or after completion of finishing operations.
5.9 Printed devices on, or associated with, manufacturing lines used to imprint labeling upon drug product until label or case is monitored to assure that all imprinting conforms to print specified in batch production record.