Standard Operating Procedure for Managing Raw Materials

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the handling of raw materials to ensure their integrity, quality, and compliance with regulatory requirements for the production of ocular dosage forms.

2) Scope

This SOP applies to all raw materials used in the production of ocular dosage forms, including eye drops, ointments, gels, and inserts, within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the receipt, storage, handling, and documentation of raw materials. Warehouse personnel are responsible for the proper handling and storage of raw materials, while quality control personnel are responsible for inspecting and releasing raw materials for production. Production personnel are responsible for using raw materials according to approved procedures and maintaining accurate records.

4) Procedure

4.1 Receipt of Raw Materials

1. Inspect incoming raw materials for any visible damage or contamination.
2. Verify that the raw materials match the purchase order specifications and accompanying documentation.
3. Record the receipt of raw materials in the inventory management system, including the date, quantity, and batch number.
4. Place raw materials in the designated quarantine area until they are inspected and released by quality control.

4.2 Inspection and Release

1. Quality control personnel should sample and test the raw materials according to approved specifications and testing methods.
2. Record the results of the testing in the quality control logbook.
3. If the raw materials meet the specified criteria, they should be released for use in production. Record the release in the inventory management system.
4. If the raw materials do not meet the specified criteria, they should be rejected and returned to the supplier or disposed of according to the company’s disposal procedures.

4.3 Storage of Raw Materials

1. Store raw materials in designated storage areas that are clean, dry, and free from contamination.
2. Ensure that raw materials are stored at the appropriate temperature and humidity levels as specified by the manufacturer.
3. Label all storage containers with the material name, batch number, and expiration date.
4. Rotate stock using the first-in, first-out (FIFO) method to ensure that older materials are used before newer materials.

4.4 Handling of Raw Materials

1. Use appropriate personal protective equipment (PPE) when handling raw materials to prevent contamination and ensure personal safety.
2. Follow approved procedures for weighing, measuring, and transferring raw materials to avoid cross-contamination and ensure accuracy.
3. Record the use of raw materials in the production batch record, including the material name, batch number, and quantity used.
4. Immediately clean up any spills or leaks of raw materials to prevent contamination and maintain a safe working environment.

4.5 Documentation

1. Maintain accurate records of the receipt, inspection, storage, and use of raw materials in the inventory management system and production batch records.
2. Ensure that all records are signed and dated by the personnel responsible for the activities performed.
3. Store records in a secure location where they can be easily accessed for review and audit purposes.

4.6 Review and Approval

1. The quality assurance department should regularly review raw material handling procedures and records to ensure compliance with SOPs and regulatory requirements.
2. Any discrepancies or deviations should be investigated, documented, and resolved promptly.
3. Review and update the SOP as necessary to reflect any changes in procedures, regulations, or industry standards.

5) Abbreviations, if any

PPE: Personal Protective Equipment

FIFO: First-In, First-Out

6) Documents, if any

1. Purchase orders
2. Inventory management system records
3. Quality control logbook
4. Production batch records

7) Reference, if any

GMP Guidelines for Handling of Raw Materials in Pharmaceutical Manufacturing

8) SOP Version

Version 1.0