ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Baseline Pharmaceutical Engineering Guides (ISPE)

A series of industry publications developed in partnership with the US Food and Drug Administration (FDA). Each volume in the series is a collaborative effort of industry leaders representing a broad cross-section of manufacturers and other industry experts. The Guides document current industry practice for facilities and systems used for production of pharmaceutical products and medical devices. They are intended to:

- Establish a baseline approach to new and renovated facility design, construction, commissioning, and qualification that is based upon clear understanding of the type of product and its manufacturing process.

- Prioritize facility design features based upon the impact on product and process.

- Avoid unnecessary spending on facility features that do not contribute to consistent production of quality products.

The Guides include five product manufacturing operation based guides (vertical guides), and four support system/function based guides (horizontal guides). Published Guides include:

1. Volume 1; Bulk Pharmaceutical Chemical (1996). Superseded by Volume 1, 2nd Edition  Active Pharmaceutical Ingredients (June 2007)

2. Volume 2; Oral Solid Dosage Forms (1998). Superseded by Volume 2, 2nd Edition (November 2009)

3. Volume 3; Sterile Manufacturing Facilities (January 1999). Superseded by Volume 3, 2nd Edition – Sterile Product Manufacturing Facilities (September 2011)

4. Volume 4; Water and Steam Systems (January 2001). Superseded by Volume 4, 2nd Edition (December 2011)

5. Volume 5; Commissioning and Qualification (March 2001)

6. Volume 6; Biopharmaceutical Manufacturing Facilities (June 2004)

7. Volume 7; Risk-Based Manufacture of Pharmaceutical Products (September 2010)

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