The ISPE Good Practice Guide: Maintenance provides practical solutions and tools for ensuring quality and compliance of maintenance operations in a regulated industry. Covering current and established practices, this guide helps achieve technical and regulatory accuracy and cost-effective compliance in a new or an existing maintenance program for effective strategy and efficiency.
The shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices. The science and risk-based approach combines product development knowledge with a structured process performance and product quality monitoring system to provide for validation throughout the product lifecycle.
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated.
Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation.
The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) aims to provide practical operational guidance and drive a consistent industry approach to the use of NIMPs. The Guide contains criteria for classifying NIMPs and an overview of current NIMP regulatory requirements.
The ISPE Good Practice Guide on the Management of Engineering Standards aims to provide a common understanding and approach to the management of Engineering Standards. It is based on industry best practices and developed with input from several peer organizations. The Guide addresses the knowledge management needs associated with the identification of content, creation, review, and approval of Engineering Standards.
The ISPE Good Practice Guide on Sampling for Pharmaceutical Water, Steam, and Process Gases was created for users of water, steam, compressed air or process gases and impacts facilities, production, and quality control personnel within a facility.
Published: March 2014 Pages: 120 Table of Contents Appendix 2 Special Pricing for Emerging Economies Currently there are no standards or guidelines for system functionality that manage Investigational Medicinal Products (IMPs). Lack of standards for
Published: March 2013 Pages: 42 Table of Contents Special Pricing for Emerging Economies This Guide was written to create methods for standardizing the format, design and content of clinical trial booklet labels. Because booklet labels contain vital
Published: October 2016 Pages: 116 Table of Contents Special Pricing for Emerging Economies The ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring provides industry good manufacturing practices for the temperature mapping