SOP on Packaging and Labeling Operations

SOP on Packaging and Labeling Operations

1.0 Purpose: This SOP describes the guidelines for packaging and labeling operations for manufacture of a drug batch

2.0 Scope: This SOP applies to Production Chemist and operating staff.

3.0 Responsibility: Production Chemist to ensure that procedure is followed.

4.0 Materials and Equipment: As required.

5.0 Procedure: The procedures are designed to assure that correct labeling and packaging materials are used for drug products. These procedures incorporate the following features –

5.1 Prevention of mix-ups and cross contamination by physical or spatial separation from operations on other products.

5.2 Identification and handling of filled drug product containers that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots. Identification need not to be applied to each individual container but it is sufficient to determine name, strength, quantity of contents, and lot or control number of each container.

5.3 Identification of drug product with a lot or control number that permits determination of history of manufacture and control of batch.

5.4 Examination of packaging and labeling materials for suitability and correctness before packaging operations, and documentation of such examination in batch production record.

5.5 Inspection of packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations. Inspection is also made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection are documented in batch production records