Standard Operating Procedure for Storage System for Finished Products in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the storage of finished products in the pharmaceutical manufacturing facility, ensuring proper inventory management, traceability, and compliance with regulatory requirements.

2) Scope

This SOP applies to the storage area designated for finished products within the pharmaceutical manufacturing facility.

3) Responsibilities

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

4) Procedure

4.1 Receipt of Finished Products

1. Receive finished products from the production department as per the receipt procedure.
2. Verify the quantity and quality of received finished products against the batch records and specifications.
3. Label each received finished product container with an identification number and date of receipt.
4. Store finished products in designated storage areas based on their storage conditions and compatibility.

4.2 Storage Conditions

1. Ensure that storage conditions (temperature, humidity, light exposure) for each finished product 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 finished products stored in the storage system.
2. Implement a first-in, first-out (FIFO) system to ensure proper stock rotation and minimize the risk of product expiration.
3. Conduct regular physical inventory counts and reconcile with inventory records.

4.4 Handling and Issuance

1. Handle finished products with care to prevent damage or contamination during storage and retrieval.
2. Issue finished products for distribution based on approved orders and shipping documentation.
3. Record all finished product transactions in the inventory management system and distribution records.

4.5 Security and Access Control

1. Implement security measures to prevent unauthorized access to finished product 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 finished products 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. Finished product receipt records
2. Inventory management records
3. Environmental monitoring records
4. Order and distribution records

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0