Course Overview

Packaging operations constitute the last manufacturing step before release of a product to the market. They convert bulk product to the final product.

Packaging for medicinal products is subject to Good Manufacturing Practice rules similar to those for the products themselves. In this module we describe the functions that packaging must fulfil and the quality controls that are applied to packaging materials and operations. We set out the requirements for control of printed materials. We describe preparation, in-process control, and completion of a packaging run. Finally, we explain how to carry out reconciliation of packaging materials.

• Describe the functions of packaging and give examples of controls applied to packaging materials and operations to provide assurance of quality

• Specify requirements for control of printed materials

• Adopt good practice in the preparation, in-process control, and completion of a packaging run

• Explain how to carry out reconciliation of packaging materials