Standard Operating Procedure of Labeling and Documentation

Purpose

The purpose of this SOP is to establish guidelines for labeling products and maintaining accurate documentation in the pharmaceutical warehouse.

Scope

This SOP applies to all personnel involved in the labeling and documentation process within the warehouse.

Responsibilities

• Warehouse Manager: Overall responsibility for ensuring compliance with labeling and documentation SOP.
• Labeling Personnel: Responsible for labeling products accurately and legibly according to SOP.
• Documentation Clerk: Responsible for maintaining accurate documentation records in the electronic database.
• Quality Assurance: Responsible for verifying the accuracy and completeness of labels and documentation.

Procedure

1. Labeling of Products:
   • Ensure that all products are labeled accurately with the correct product name, strength, and quantity.
   • Use standardized labeling formats and templates to maintain consistency.
   • Apply labels securely to product containers or packaging using appropriate adhesive methods.
2. Documentation:
   • Maintain accurate records of all incoming and outgoing products in the electronic database.
   • Record essential information such as product name, batch number, expiration date, and quantity.
   • Ensure that all documentation is legible, complete, and up-to-date.
3. Document Review:
   • Regularly review documentation records for accuracy and completeness.
   • Verify that labels match the corresponding documentation entries for each product.
   • Address any discrepancies or errors promptly and document corrective actions taken.
4. Documentation Storage:
   • Store electronic documentation records in a secure and organized manner.
   • Ensure that documentation is easily retrievable for reference or audit purposes.
   • Implement backup procedures to prevent loss of documentation due to system failures or data corruption.

Abbreviations

• SOP: Standard Operating Procedure

Documents

• Labeling Templates
• Electronic Documentation Records
• Corrective Action Reports

SOP Version

Version 1.0