Standard Operating Procedure for Packaging Material Handling and Control in Ointment Formulation

1) Purpose

The purpose of this SOP is to outline the procedures for handling and controlling packaging materials used in the formulation of ointments, ensuring their quality and preventing contamination.

2) Scope

This SOP applies to all personnel involved in the receipt, handling, storage, and control of packaging materials used in the ointment formulation process.

3) Responsibilities

– Quality Assurance (QA): Responsible for inspecting and approving packaging materials and for maintaining related documentation.
– Warehouse Staff: Responsible for receiving, inspecting, and storing packaging materials according to established procedures.
– Production Staff: Responsible for using packaging materials according to SOP and reporting any issues or discrepancies.

4) Procedure

1. Receipt of Packaging Materials:
1.1 Arrival and Initial Inspection:
1.1.1 Verify the identity of the delivery vehicle and check for any signs of tampering or damage.
1.1.2 Record the arrival details in the packaging material log.
1.2 Unloading and Inspection:
1.2.1 Unload materials in a designated area to avoid contamination.
1.2.2 Inspect packaging for integrity and labeling accuracy.
1.2.3 Document any discrepancies or damage and notify QA.

Material Identification and Storage:
2.1 Identification:
2.1.1 Ensure all packaging materials are properly labeled with material name, batch number, and expiration date.
2.1.2 Cross-check labels with the delivery documentation.

2.2 Storage:
2.2.1 Store packaging materials in designated areas according to their storage requirements.
2.2.2 Maintain storage conditions as specified (e.g., temperature, humidity).

Handling of Packaging Materials:
3.1 Handling Procedures:
3.1.1 Use appropriate handling equipment to avoid contamination and damage.
3.1.2 Follow GMP guidelines during all handling processes.
3.1.3 Record any transfers of materials in the inventory management system.

Quality Control:
4.1 Inspection and Testing:
4.1.1 Perform inspections and tests on incoming packaging materials to ensure they meet quality standards.
4.1.2 Document the results and approve or reject materials based on inspection outcomes.

4.2 Rejected Materials:
4.2.1 Clearly label and segregate rejected materials to prevent use.
4.2.2 Document the reasons for rejection and dispose of materials according to SOP.

5) Abbreviations, if any

– QA: Quality Assurance
– GMP: Good Manufacturing Practice
– SOP: Standard Operating Procedure

6) Documents, if any

– Packaging Material Specifications
– Delivery and Inspection Log
– Quality Control Records
– Inventory Records

7) Reference, if any

– FDA Current Good Manufacturing Practice (CGMP) Regulations
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0