Pharmaceutical Dosage Form Development

The purpose of a pilot plant is to integrate development, early development activities, clinical supply manufacture, technology evaluation, scale up, and transfer to production sites.

Scale-up is the process of increasing the batch size or applying the same process to different output volumes.

The pre-commercial production system of a pilot plant includes new production technology and the production of small volumes of new technology-based products.

<p>The pilot plant studies must include a Current Good Manufacturing Practices (cGMP) environment, highly trained and skilled staff, and equipment.</p> Signup and view all the answers

<p>The purpose of learning about SUPAC guidelines is to gain sufficient knowledge about the regulatory guidelines for post-approval changes in pharmaceutical dosage forms.</p> Signup and view all the answers