Standard Operating Procedure for Storage System for Raw Materials in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish guidelines for the storage of raw materials used in the manufacturing of ocular dosage forms, ensuring proper inventory management and adherence to regulatory requirements.

2) Scope

This SOP applies to the storage area designated for raw materials within the pharmaceutical manufacturing facility.

3) Responsibilities

Warehouse personnel are responsible for receiving, storing, and issuing raw materials according to established procedures. Quality control personnel are responsible for conducting inspections and ensuring the integrity and compliance of stored raw materials.

4) Procedure

4.1 Receipt of Raw Materials

1. Receive raw materials from approved suppliers as per the receiving procedure.
2. Verify the quantity and quality of received raw materials against the accompanying documentation.
3. Label each received raw material container with an identification number and date of receipt.
4. Store raw materials in designated storage areas based on their compatibility and storage conditions.

4.2 Storage Conditions

1. Ensure that storage conditions (temperature, humidity, light exposure) for each raw material are maintained as per specified requirements.
2. Monitor and record storage conditions regularly to ensure compliance with specified limits.

4.3 Inventory Management

1. Maintain an accurate inventory of all raw materials stored in the storage system.
2. Implement a first-in, first-out (FIFO) system to ensure proper stock rotation and minimize the risk of material expiration.
3. Conduct regular physical inventory counts and reconcile with inventory records.

4.4 Handling and Issuance

1. Handle raw materials with care to prevent damage or contamination during storage and retrieval.
2. Issue raw materials for production based on approved material requisitions and batch records.
3. Record all raw material transactions in the inventory management system and batch production records.

4.5 Security and Access Control

1. Implement security measures to prevent unauthorized access to raw materials storage areas.
2. Restrict access to authorized personnel only and maintain a visitor log for monitoring purposes.

4.6 Environmental Monitoring

1. Monitor environmental conditions in the storage area, including temperature and humidity, using calibrated monitoring equipment.
2. Document environmental monitoring data and review regularly for deviations from specified limits.

4.7 Documentation

1. Maintain records of receipt, storage, and issuance of raw materials in accordance with GDP (Good Documentation Practices).
2. Ensure all documentation is completed accurately, signed, and dated by authorized personnel.

4.8 Review and Compliance

1. Regularly review and update this SOP to reflect current practices and regulatory requirements.
2. Ensure compliance with relevant regulations and guidelines, including GMP (Good Manufacturing Practices).

5) Abbreviations, if any

SOP: Standard Operating Procedure

GMP: Good Manufacturing Practices

GDP: Good Documentation Practices

6) Documents, if any

1. Raw material receipt records
2. Inventory management records
3. Environmental monitoring records
4. Material requisitions

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0