Baseline® Pharmaceutical Engineering Guides for New and Renovated Facilities

Published: June 2004
Pages: 196

 Table of Contents 

The Biopharmaceutical Manufacturing Facilities Baseline® Guide explores products and facilities that house biotechnological processes. More specifically, it applies to process design ties to facility design, controlled processing, preventing contamination, and segregation and flow.

 Bound Version

Published: March 2001
Pages: 142

 Table of Contents

The Commissioning and Qualification Baseline® Guide provides advice and guidance that may be applied to all types of facilities, utilities, and equipment found in the healthcare industry. The Guide has incorporated comments from industry representatives from all areas and disciplines, FDA Field Investigators, and personnel from the FDA's Center for Drug Evaluation and Research (CDER).

 Bound Version

Published: January 2001
Pages: 228

 Table of Contents

The Water and Steam Systems Baseline® Guide is intended for the design, construction, and operation of new water and steam systems. The purpose of this Guide is to focus upon engineering issues and provide cost-effective water and steam systems. The Guide is intended primarily for regulatory compliance for the domestic US market, and follows US standards and references. Issues relating to Europe are discussed in the Guide's appendix.

 Bound Version

 Bound Version

Published: February 1998
Pages: 92

 Table of Contents

Many Oral Solid Dosage (OSD) facilities run multiple products in processing areas designed for quick turnaround without unacceptable risk of product exposure (i.e., dust and cross-contamination). Additionally, potent or toxic active ingredients are becoming increasingly common and present their own design challenges. The Oral Solid Dosage Baseline® Guide assists professionals by establishing consistent and minimum parameters for facility design, which address these concerns and meet GMP requirements.

 Bound Version

Published: June 2007
Pages: 188

 Table of Contents

This revised Guide builds on the original principles of ISPE’s Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, (originally entitled Bulk Pharmaceutical Chemicals). The ISPE API Baseline Guide also incorporates and builds on new regulations and guidance, such as:

• ICH Q7
• ICH Q9
• GAMP 4
• 21 CFR Part 11
• Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (cGMP)
• FDA Draft Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance

• Active Pharmaceutical Ingredient characterization
• Critical process steps
• Potential contamination
• Good Engineering Practice
• Levels of protection
• Critical process parameter
• Critical instruments
• Critical unit operation (new)
• Contamination review (new)
• Design qualification (new)
• Intended patient use (new)
• Direct, indirect, and no impact systems (new)
• Critical and non-critical components (new)
• Facility designation (new)
• Process Analytical Technologies (new)
• Process review (new)
• Risk to patient (new)
• Understanding of process (new)

 Bound Version

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