Standard Operating Procedure for Handling and Storage of Finished Products
1) Purpose
The purpose of this SOP is to establish procedures for the proper handling, packaging, labeling, and storage of finished products after manufacturing dental dosage forms to ensure product integrity, traceability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all finished products produced during the manufacturing of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Production Department is responsible for executing handling and storage procedures. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.
4) Procedure
4.1 Handling and Packaging
4.1.1 Handle finished products with care to prevent damage or contamination during transfer and packaging.
4.1.2 Use approved packaging materials and containers suitable for the product type (e.g., tubes, bottles).
4.1.3 Label each finished product container with batch details, expiry date, and other required information.
4.2 Storage Conditions
4.2.1 Store finished products in designated storage areas under controlled environmental conditions (e.g., temperature, humidity).
4.2.2 Ensure storage areas are clean, dry, and secure to prevent unauthorized access and environmental contamination.
4.3 Inventory Management
4.3.1 Maintain accurate inventory records of finished products, including batch numbers, quantities, and locations.
4.3.2 Implement a first-in, first-out (FIFO) system to ensure older batches are used or shipped first.
4.4 Distribution and Shipping
4.4.1 Prepare finished products for distribution or shipping according to customer orders or distribution schedules.
4.4.2 Verify shipping documentation and ensure compliance with transportation regulations.
4.5 Documentation
4.5.1 Document all handling, packaging, labeling, storage, and distribution activities in batch records and product logbooks.
4.5.2 Archive documentation according to retention policies and regulatory requirements.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Batch Records
Product Inventory Logs
Shipping and Distribution Records
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
Pharmacopeial standards (e.g., USP, EP)
8) SOP Version
Version 1.0
