Standard Operating Procedure for Raw Material Handling and Receipt in Ointment Formulation

1) Purpose

The purpose of this SOP is to establish the procedures for the handling and receipt of raw materials used in the formulation of ointments. This ensures that all raw materials meet specified quality standards and are handled in a manner that prevents contamination and maintains their integrity.

2) Scope

This SOP applies to all personnel involved in the receipt, handling, and storage of raw materials used in the ointment formulation process. It includes procedures from the arrival of materials to their storage in designated areas.

3) Responsibilities

– Quality Assurance (QA): Responsible for inspecting and approving incoming materials, and for maintaining related documentation.
– Warehouse Staff: Responsible for receiving, inspecting, and storing raw materials according to established procedures.
– Production Staff: Responsible for requesting and handling raw materials during the production process.

4) Procedure

1. Receipt of Raw 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 raw material log.
1.2 Unloading and Inspection:
1.2.1 Unload materials in a designated area to avoid contamination.
1.2.2 Inspect containers for integrity and labeling accuracy.
1.2.3 Document any discrepancies or damage and notify QA.

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

2.2 Sampling:
2.2.1 Perform sampling according to the SOP for Sampling and Testing of Raw Materials.
2.2.2 Send samples to the Quality Control (QC) lab for testing and approval.

Storage of Raw Materials:
3.1 Quarantine:
3.1.1 Store raw materials in quarantine until QC approval is received.
3.1.2 Clearly label quarantine areas to prevent unauthorized use.

3.2 Approved Storage:
3.2.1 Upon approval, move raw materials to designated storage areas.
3.2.2 Maintain storage conditions as specified (e.g., temperature, humidity).

Handling of Raw Materials:
4.1 Handling Procedures:
4.1.1 Use appropriate handling equipment to avoid contamination and damage.
4.1.2 Follow GMP guidelines during all handling processes.
4.1.3 Record any transfers of materials in the inventory management system.

Documentation and Records:
5.1 Maintain detailed records of all received raw materials, including inspection and test results.
5.2 Ensure all records are accurate, complete, and readily available for audits.

5) Abbreviations, if any

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

6) Documents, if any

– Raw Material Specifications
– Delivery and Inspection Log
– Sampling and Testing SOP
– 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