Standard Operating Procedure for Packaging Equipment

1) Purpose

The purpose of this SOP is to provide guidelines for the operation and maintenance of packaging equipment used in the final packaging of dental dosage forms to ensure proper packaging and compliance with regulatory standards.

2) Scope

This SOP applies to all packaging equipment used in the final packaging process of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Production Department is responsible for operating and cleaning the packaging equipment. The Quality Assurance (QA) Department is responsible for verifying and documenting compliance with this SOP.

4) Procedure

4.1 Preparation

4.1.1 Verify that the packaging equipment is clean and in good working condition before use.

4.1.2 Ensure all packaging materials (e.g., cartons, inserts) are prepared and ready for use according to the batch record.

4.2 Setup and Adjustment

4.2.1 Set up the packaging equipment as per the manufacturer’s instructions and batch record requirements.

4.2.2 Adjust machine settings such as speed, temperature, and pressure for optimal packaging.

4.3 Packaging Operation

4.3.1 Start the packaging equipment and load products into the packaging line.

4.3.2 Monitor the packaging process to ensure correct packaging materials are used and products are packaged according to specifications.

4.3.3 Conduct checks for package integrity, sealing, and labeling as per the batch