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
The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.
Guidance Docs
Published: 15 December 2011 Pages: 264 Table of Contents Special Pricing for Emerging Economies The Baseline Guide Volume 4: Water & Steam Systems (Second Edition) is the only comprehensive guide of its kind and aims to assist with the design,
Guidance Docs
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 Docs
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 Docs
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 Docs
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 Docs
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.