SOP on Labeling & Packaging Drug Product Inspection
1.0 Purpose: This SOP describes the guidelines for inspection to be carried out during labeling and packaging of a drug batch
2.0 Scope: This SOP applies to Production Chemist, Quality Control Chemist and operating staff.
3.0 Responsibility: Production Manager to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure:
5.1 Packaged and labeled products are examined during finishing operations to provide assurance that containers and packages in lot have correct label.
5.2 A representative sample of units is collected at completion of finishing operations and visually examined for correct labeling.
5.3 Results of these examinations are recorded in batch production record.
5.4 Compliance with intent that inspection and documentation procedures continue throughout labeling and packaging operation to prevent incorrect components or procedures from being utilized.
5.5 The majority of these on-line inspections are often performed by suitable trained production personnel, with Quality Control confirming compliance with defined inspection procedures and performing periodic audit.