Скачать или смотреть 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities

An ISPE survey of compounding pharmacies and regulators overwhelmingly demonstrated that 503B outsourcing facilities could benefit from comprehensive guidance summarizing regulatory requirements. The ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities aims to help facilities understand the FD&C Act Section 503B requirements. This ISPE Guide combines FDA regulations and recommendations with pharmaceutical industry standards, providing a go-to document for any size 503B facility. The compounding process is covered, from the importance of CGMPs to establishing a Quality system (including qualifying suppliers and vendors), receipt of raw materials/active ingredients, and shipping of the finished drug product.

Get the guide: https://ispe.org/publications/guidanc...