Standard Operating Procedure for Storing Finished Products

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the storage of finished products to ensure their quality, integrity, and compliance with regulatory requirements for ocular dosage forms.

2) Scope

This SOP applies to all finished products, including eye drops, ointments, gels, and inserts, produced within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the proper storage, handling, and documentation of finished products. Warehouse personnel are responsible for storing finished products according to specified conditions. Quality control personnel are responsible for inspecting and releasing finished products for distribution. Production personnel are responsible for maintaining accurate records of finished products.

4) Procedure

4.1 Receipt of Finished Products

1. Inspect finished products for any visible damage or contamination upon receipt from the production area.
2. Verify that the finished products match the production batch records and accompanying documentation.
3. Record the receipt of finished products in the inventory management system, including the date, quantity, and batch number.

4.2 Storage Conditions

1. Store finished products in designated storage areas that are clean, dry, and free from contamination.
2. Ensure that finished products are stored at the appropriate temperature and humidity levels as specified by the manufacturer.
3. Maintain storage conditions within the specified range using monitoring devices such as temperature and humidity sensors.
4. Store finished products away from direct sunlight and any sources of heat or moisture.

4.3 Organization and Labeling

1. Organize finished products on shelves or pallets to facilitate easy access and inventory management.
2. Label all storage containers and shelves with the product name, batch number, and expiration date.
3. Implement a first-in, first-out (FIFO) inventory system to ensure that older products are distributed before newer ones.

4.4 Handling of Finished Products

1. Use appropriate material handling equipment, such as forklifts or pallet jacks, to move finished products within the storage area.
2. Ensure that handling equipment is clean and well-maintained to prevent contamination.
3. Follow approved procedures for transferring finished products to prevent damage and ensure accuracy.

4.5 Documentation

1. Maintain accurate records of the storage conditions, including temperature and humidity logs.
2. Record the movement of finished products within the storage area in the inventory management system.
3. Ensure that all records are signed and dated by the personnel responsible for the activities performed.

4.6 Review and Approval

1. The quality assurance department should regularly review storage 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

FIFO: First-In, First-Out

6) Documents, if any

1. Production batch records
2. Inventory management system records
3. Temperature and humidity logs

7) Reference, if any

GMP Guidelines for Storage of Finished Products in Pharmaceutical Manufacturing

8) SOP Version

Version 1.0