Baseline Guides

Created with input from various global regulatory agencies, Baseline Guides are intended to establish a compliant minimum acceptable (baseline) approach to the topic area. They typically focus on the “what”.

Language
English
Guidance Docs

Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

Baseline Guides
Published: June 2019 Pages: 212 Table of Contents Special Pricing for Emerging Economies The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach
Guidance Documents
Guidance Docs

Baseline Guide Vol 4: Water & Steam Systems 3rd Edition

Baseline Guides
The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance.
Guidance Documents
Guidance Docs

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

Baseline Guides
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) covers engineering aspects of designing new sterile products manufacturing facilities and modifications of existing facilities. The Guide focuses on how to provide cost-effective facilities which make best use of available modern technologies to ensure that products of the highest quality are consistently manufactured.
Guidance Documents
Guidance Docs

Baseline Guide Vol 1: Active Pharmaceutical Ingredients

Baseline Guides
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
Guidance Documents
Guidance Docs

Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition

Baseline Guides
The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, for managing the risk of cross-contamination within shared facilities. Risk management processes should be used to determine and document reasonable and acceptable risk, in order to maintain product quality and operator safety and to satisfy regulatory requirements.
Guidance Documents
Guidance Docs

Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition

Baseline Guides
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.
Guidance Documents
Guidance Docs

Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 2nd Edition

Baseline Guides
This second edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends to further reinforce the concepts described in the first edition of the Guide, provide examples of how these concepts can be put into practice, and detail the value and benefits of the approach described.