Initiatives

The ISPE Baseline Guide: OSD Forms is intended to offer a tool for consistent framework for regulatory interpretation, while still allowing a flexible, innovative, and compliant approach to facility design, construction, commissioning, and qualification. This approach is intended to allow manufacturers to better serve their customers by helping reduce costs and improve product quality.

The ISPE Drug Shortages Prevention Model serves as a guide to help prevent drug shortages by providing quality, regulatory, and technical recommendations for the pharmaceutical manufacturing industry. The ISPE Drug Shortages Task Team developed the model as a follow up to the ISPE Drug Shortages Prevention Plan that was released in 2014. The model provides expanded guidance that reflects the new insight and best practices that have emerged in the past several years.

The Quality Excellence Report shares insights on quality culture improvement across six key dimensions and outlines a series of practical and powerful approaches, practices, and tools to support implementation of the cultural excellence framework and promote behavioral change that will ultimately benefit the patient and the business.