Standard Operating Procedure for Storage and Handling of Raw Materials in Ointment Formulation

1) Purpose

The purpose of this SOP is to establish the procedures for the proper storage and handling of raw materials used in ointment formulation, ensuring their integrity, quality, and compliance with regulatory standards.

2) Scope

This SOP applies to all personnel involved in the storage and handling of raw materials in the ointment formulation process. It covers procedures for storing, labeling, and handling raw materials from receipt to production use.

3) Responsibilities

– Warehouse Staff: Responsible for storing and handling raw materials according to the SOP and maintaining inventory records.
– Quality Assurance (QA): Responsible for ensuring that storage conditions meet specified requirements and for conducting regular audits.
– Production Staff: Responsible for using raw materials according to SOP and reporting any discrepancies or issues.

4) Procedure

1. Storage Conditions:
1.1 Environmental Controls:
1.1.1 Maintain storage areas within specified temperature and humidity ranges.
1.1.2 Monitor and record environmental conditions regularly.
1.1.3 Implement corrective actions if conditions deviate from specifications.
1.2 Segregation and Labeling:
1.2.1 Segregate raw materials based on their status (quarantine, approved, rejected).
1.2.2 Clearly label each material with name, batch number, expiration date, and status.

Handling Procedures:
2.1 Receiving and Storing Materials:
2.1.1 Verify the identity and condition of materials before storing.
2.1.2 Store materials in designated areas according to their storage requirements.

2.2 Inventory Management:
2.2.1 Maintain accurate inventory records, including quantities, batch numbers, and storage locations.
2.2.2 Conduct regular inventory audits and reconcile any discrepancies.

Material Use and Transfer:
3.1 Issuing Materials for Production:
3.1.1 Verify material identity and status before issuing for production.
3.1.2 Record material issuance in the inventory management system.

3.2 Returning Unused Materials:
3.2.1 Return unused materials to storage in their original containers.
3.2.2 Update inventory records to reflect the return.

Documentation and Records:
4.1 Maintain detailed records of storage conditions, material movements, and inventory levels.
4.2 Ensure records are complete, accurate, and readily accessible for audits.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Storage Condition Logs
– Inventory Records
– Material Status Labels

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