ISPE Good Practice Guides

ISPE Good Practice Guides (GPGs) provide information or advise on a particular topic area and explain underlying technical principles and suggest solutions in an area where no single answer is correct and where several outcomes may be possible. GPGs address technical areas related to facilities and pharmaceutical manufacturing, and may highlight topics that propose how to meet the intent of a specific aspect of a GMP.

ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products

Published: August 2007 Pages: 92 View Table of Contents

With the rapid growth in the biopharmaceutical industry over the past two decades, the number of newly approved biological products has dramatically increased. In 2005, a record 21 biological products received US Food and Drug Administration (FDA) approvals, including therapies for the treatment of rheumatoid arthritis, diabetes, cancer, and rare genetic disorders.

With the increasing number of approved biological products on the global market come major challenges for many biopharmaceutical companies, especially during the critical process development and manufacturing stages of product development.

This Guide will consider the major issues that will confront a biopharmaceutical company in moving therapeutic biological products from the laboratory to the clinic and beyond. The Guide is intended to provide readers with an understanding of issues surrounding product and process development, manufacturing, investigational product supply chain management, quality control/quality assurance, and global regulatory requirements for biopharmaceuticals.

The intended audience for this Guide includes the following disciplines:

• Clinical Supply/Clinical Trial Materials 
• Clinical Research 
• Manufacturing 
• Project Management 
• Quality Assurance/Quality Control 
• Regulatory Affairs 
• Research and Development

The Guide specifically addresses the methods and challenges surrounding recombinant therapeutic biological product development, including considerations during its use in clinical trials.

It focuses on project planning/management, preclinical/clinical phases, comparability and bridging studies, Active Pharmaceutical Ingredient (API)/Drug Substance (DS)/Drug Product (DP)/placebo process development, manufacturing of DS/DP, process validation, supply chain management of biological investigational products for clinical trials, quality control/quality assurance considerations, and global regulatory strategies.

The regulations and guidelines from the US, EU, Canada, Japan, and ICH have been considered in the development of this Guide. While not in the scope of this Guide, it is recognized that the development of other biologics (e.g., cellular and gene therapy) may require additional considerations for their successful product development from the laboratory to the clinic.

 Order the bound version from the ISPE On-line Store
 Also available as a secure PDF* for immediate download
  from Techstreet/Thompson Scientific

* What is a secure PDF?

ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems

Published: February 2007 Pages: 45, plus appendices Table of Contents Executive Summary Work smarter, not harder, when it comes to the commissioning and qualification of your pharmaceutical water and steam systems. This Guide will show you how to change your focus from a “qualify everything” approach, to a more efficient and cost-effective risk-based evaluation of individual system components or process steps.

The ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems provides an alternative approach, based on “risk assessment” principles and “process understanding” for the commissioning and qualification of direct impact water and steam systems.

Specifically, this Guide:

• Provides an understanding of the importance of C&Q and how it fits into the Validation Life Cycle
• Explains and demonstrates the impact assessment process for water and steam systems and typical system boundaries and non-critical components
• Discusses critical parameters – critical quality attributes and critical process operating parameters
• Discusses business essential parameters – key business considerations for design, construction, commissioning, and qualification. Some of these relate to non-product quality items like Health, Safety, and Environmental (HSE) considerations, IT, or other “commissioning only” project scope items.
• Provides identification of and discussion of project scope activities included in the qualification of water and steam systems
• Provides information on the User Requirement Specification (URS), Functional Design Specification (FDS), and Detailed Design Specification (DDS)
• Demonstrates theories by providing examples

The Guide, intended as a supplement to the ISPE Baseline® Guide on Commissioning and Qualification, aims to apply the principles discussed in the ISPE Baseline® Guide to direct water and steam systems.

 Order the bound version from the ISPE On-line Store
  Also available as a secure PDF* for immediate download
  from Techstreet/Thompson Scientific

* What is a secure PDF?

ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment

Published: September 2005 Pages: 84 Table of Contents This ISPE Good Practice Guide provides a standard methodology for use in testing the containment efficiency of solids handling systems used in the pharmaceutical industry under closely defined conditions. It covers the main factors that affect the test results for specific contained solids handling systems, including material handled, room environment, air quality, ventilation and operator technique.

  Order the bound version from the ISPE On-line Store
  Also available as a secure PDF* for immediate download
  from Techstreet/Thompson Scientific

* What is a secure PDF?

ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment Bound / Electronic Set 

The electronic version of the ISPE Good Practice Guide features enhanced capabilities including bookmarks and links from the Guide’s Table of Contents for easy access to all sections of the electronic document, as well as pages (thumbnails) for simplicity of navigation. The electronic version is an accurate reproduction of the printed Guide, which is searchable and provided on CD-ROM for portability. The bound / electronic set includes one bound version of the Guide, and one CD containing a PDF document** of the Guide.

 Order the bound / electronic set from the ISPE On-line Store

** System requirements and user information for the electronic document.

ISPE Good Practice Guide: Technology Transfer

Published: March 2003 Pages: 128 Table of Contents A Guide on transferring expertise and technology associated with APIs, Dosage Forms, and Analytical Methods. In many cases, the cost and time required to transfer technology has risen due to inconsistent interpretation of regulatory requirements. Avoid these pitfalls by ordering your copy of the ISPE Good Practice Guide: Technology Transfer today.

 Order the bound version from the ISPE On-line Store
  Also available as a secure PDF* for immediate download
  from Techstreet/Thompson Scientific

* What is a secure PDF?

The ISPE Good Practice Guide: Technology Transfer is used in association with ISPE training courses Technology Transfer for Active Pharmaceutical Ingredients and Technology Transfer for Finished Dosage Forms, Oral Solids and Sterile Liquids. Attendees of the training course receive a complimentary copy of this publication.

ISPE Good Practice Guide: Technology Transfer Bound / Electronic Set

The electronic version of the ISPE Good Practice Guide features enhanced capabilities including bookmarks and links from the Guide’s Table of Contents for easy access to all sections of the electronic document, as well as pages (thumbnails) for simplicity of navigation. The electronic version is an accurate reproduction of the printed Guide, which is searchable and provided on CD-ROM for portability. The bound / electronic set includes one bound version of the Guide, and one CD containing a PDF document** of the Guide.

 Order the the bound / electronic set from the ISPE On-line Store

** System requirements and user information for the electronic document.

ISPE Good Practice Guides Under Development

Good Engineering Practice
The ISPE Good Practice Guide: Good Engineering Practice has undergone review by specified reviewers and the Task Team is incorporating comments and enhancing the Appendices. In addition to comparing the current draft with existing international documents, a European sub-team has been integrated to provide input. The Guide describes the fundamental elements of GEP as they should exist in pharmaceutical and related industries. It provides a benchmark tool for assessment of GEP within any organization and a model as a means of identifying possible improvements to practices.

Heating, Ventilation, and Air Conditioning (HVAC)
The Task Team is preparing the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) for external review. The Guide aims to provide a common understanding of critical HVAC issues and a set of common practices to address these issues, gathering together information which is currently included in appendices of the various Baseline Guides into a single resource. The Guide will provide supporting information and HVAC practices and will explore critical and non-critical HVAC issues for the production of pharmaceuticals, biopharmaceuticals, and medical devices.

 Now available: ISPE Good Practice Guide: HVAC Outline

Science and Risk-Based Cleaning Process Development and Validation
This Guide will cover development of cleaning processes, cleaning validation, and use of statistics in cleaning validation and PAT. Key components are: 

• Cleaning Process Development 
• Cleanability Studies 
• Health Based Safety Thresholds 
• Cleaning Failure Modes and Effects Analysis 
• Cleaning Process Performance Capability.

These activities develop scientific knowledge of cleaning processes and are ultimately linked to the protection of the patient.

 Now available: ISPE Good Practice Guide: Science and Risk-Based Cleaning Process Development and Validation Outline

Cold Chain Management
The industry needs specific guidance on how to attain consistency in the transport of the products requiring specific parameters to maintain safety, efficacy and quality of the medicinal product during transportation from the manufacturer to the consumer. This new Guide is in the early stages of development. Areas to be covered are: 

• Equipment 
• Regulatory Requirements 
• Qualification of Packaging 
• Anti-counterfeiting systems

Goal is to provide practical guidance in the area of cold chain management, with examples of typical documents.

 Now available: ISPE Good Practice Guide: Cold Chain Management Outline

Direct Impact Process Gas Systems
This new Guide is in the early stages of development. Sections to be included are:

• global direct impact gas standards used in the pharmaceutical and biotechnology industry and regulatory considerations 
• gas options and facility system conceptual planning – raw gas through high purity gases 
• gas generation system design options and processes 
• gas distribution system options and processes 
• major direct impact gas system issues – microbial control strategies, materials of construction options, instrumentation, construction issues and related issues including selection of gas filters 
• commissioning and qualification of direct impact gas systems including determination of system boundaries (no, indirect and direct impact systems), non-critical and critical components, critical quality attributes, sampling programs, etc. 
• gas system operation and maintenance considerations
  

Pharmaceutical Testing Laboratories
The Task Team is preparing the ISPE Good Practice Guide: Pharmaceutical Testing Laboratories for external review. The Guide focuses on key elements necessary to maintain a high level of cGMP compliance and produce accurate, precise, and consistent test results. The two main objectives for the Guides are to provide guidelines for the compliant operation of a Quality Control Laboratory designed to meet the regulatory requirements, and to provide guidance for any laboratory performing analysis for the pharmaceutical industry, by assisting cGMP laboratories in designing and maintaining compliant systems.