ISPE Good Practice Guide Heating Ventilation, and Air Conditioning (HVAC) Anticipated Release August 2009

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.

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ISPE Good Practice Guide: Maintenance

Published: May 2009
Pages: 108

 Table of Contents

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. Offering maximum flexibility, this guide clearly helps define roles and responsibilities across cross-functional areas and recommends a systematic approach aimed at continuous improvement of maintenance operations. The Guide is focused on maintenance in cGMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program. The Guide seeks to enable widespread adaptation and encourage innovation.

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ISPE Good Practice Guide: Good Engineering Practice

Published: December 2008
Pages: 196

 Table of Contents

Good Engineering Practices (GEPs) consist of proven and accepted engineering methods, procedures, and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations. GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology leads to a balance of expenditure and activity. In addition, GEP documentation can be leveraged to support verification work. This Guide brings a wealth of information on GEPs and provides benchmarking tools of current company practices against what is considered industry good practice.

The ASTM standard (E2500) builds on the concepts of GEPs and has substantial implications for reductions in cost and time for pharmaceutical capital investment projects.

This first edition of the ISPE Good Practice Guide: Good Engineering Practice covers the complete lifecycle of engineering from concept to retirement. The Guide:

• Aims to promote a common understanding of the concept and principles of GEP defines and explains the term “Good Engineering Practice”
• Describes the fundamental elements existing in pharmaceutical and related industries
• Identifies practices, demonstrating how GEP concepts may be applied in the pharmaceutical industry considering the entire range of pharmaceutical engineering activity
• Identifies key attributes of GEP, including how GEP relates and interfaces with GxP

The Guide divides GEP activity into three sections each prefaced with the definition of the practice. Within each section, common practices and sub-practices are identified to provide illustrative examples of GEP.

Project Engineering, including

• Project Infrastructure
• Project Organization
• Value Analysis
• Planning and Monitoring
• Design Reviews
• Handover

Common Practices, including

• Standards and Procedures
• Documentation Practices
• Change Management
• Innovation and Continuous Improvement

Operation and Maintenance, including

• Engineering Manuals and Records
• Breakdown Maintenance
• Internal Audit
• Equipment Decommissioning and Retirement

This globally-reviewed document was developed through the collaboration of professionals from various sectors and geographic regions of the pharmaceutical industry with the intention of determining a common understanding of the concept and principles of GEP.

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ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products

Published: August 2007
Pages: 92

 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.

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

Published: February 2007
Pages: 45, plus appendices

 Table of Contents
 

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.

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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.

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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.

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Related Training Courses:

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.

Electronic / Bound 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.

• System requirements and user information for the electronic document.

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