Guidance Documents

Published : September 2024 Pages : 272 Table of Contents Special Pricing for Emerging Economies Heating, Ventilation, and Air Conditioning (HVAC) systems can critically affect the ability of a pharmaceutical facility to meet its objective of

Published : April 2024 Pages : 72 Table of Contents Special Pricing for Emerging Economies Following the need identified by the ISPE survey of compounding pharmacies and regulators, it is evident that compounding pharmacies would benefit from

Published: January 2024 Pages: 144 Table of Contents Special Pricing for Emerging Economies Advanced Therapy Medicinal Products (ATMPs) are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific

The biopharmaceutical industry has adapted to reflect available technologies such as single-use technologies and modular construction methodologies, products with more focused patient populations, evolving regulatory conditions, unrelenting pressures on costs, and increased focus on robust product supply while maintaining high-quality standards. This Guide presents concepts that reflect how these changes affect biopharmaceutical manufacturing facilities without sacrificing product quality, by reducing risk and enhancing the manufacturing control strategy.

Published: August 2023 Pages: 122 Table of Contents Special Pricing for Emerging Economies An ISPE survey of compounding pharmacies and regulators overwhelmingly demonstrated that 503B outsourcing facilities could benefit from comprehensive guidance

The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the design, delivery, and operation of engineered systems. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. This Guide considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP.

For the purposes of this Guide, operations are defined as the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations Management designs, operates, and improves supply chain systems for getting work done. The ISPE Good Practice Guide: Operations Management aims to provide the pharmaceutical industry with a knowledge base to promote the use of best practices and operational excellence within pharmaceutical operations management.

The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry's only guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities.

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.