ISPE

$202.50
GAMP Good Practice Guide: Electronic Data Archiving International Society for Pharmaceutical Engineering / 2007 / 152 pages ISBN: 1931879583 This Guide provides a rational and scaleable approach to electronic data archiving through the development of an archiving strategy. The implementation of such a strategy should assist organizations to achieve and maintain regulatory compliance, and to more effectively manage electronic records over the long term.
$202.50
GAMP Good Practice Guide: Validation of Laboratory Computerized Systems International Society for Pharmaceutical Engineering / 2005 / 96 pages ISBN: 1931879397 The GAMP Good Practice Guide: Validation of Laboratory Computerized Systems provides a harmonized overview of the key elements involved in the life cycle of laboratory computerized systems, from initiation to retirement. The focus of the Guide is on computerized laboratory instrumentation, data management, and analysis systems. It...
$202.50
GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures International Society for Pharmaceutical Engineering / 2005 / 240 pages ISBN: 1931879389 The appropriate management of electronic records and signatures is of current concern to both the regulated life science industry and its regulators. A new GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures has been developed by GAMP Forum, a technical subcommittee...
$202.50
GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Edition: 2nd International Society for Pharmaceutical Engineering / 2011 / 196 pages ISBN: 9781936379057 This GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP® Good Practice Guide: Validation of Process Control Systems. It provides guidance and examples on the application of the principles and framework of GAMP 5: A Risk-Based Approach to Compliant GxP...
$202.50
GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition Edition: 2nd International Society for Pharmaceutical Engineering / 2010 / 124 pages ISBN: 9781931879996 The GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program management, documentation, and corrective actions,...
$257.50
GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version) International Society for Pharmaceutical Engineering / 2008 / 356 pages ISBN: 193187963X Please note: This is the German version of GAMP 5. A version of this publication in English is also available. GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible...
$202.50
Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals International Society for Pharmaceutical Engineering / 2006 / 120 pages ISBN: 1931879486 Clinical Material (CM) supply chain management is an ever-expanding and complex field. Government agencies require that staff members are fully trained in the appropriate regulations and cGMPs, and keeping current with the rapidly changing global landscape may present a considerable challenge. The ISPE...
$257.50
GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems International Society for Pharmaceutical Engineering / 2008 / 356 pages ISBN: 1931879613 Please note: This is the English version of GAMP 5. A version of this publication in German is also available. GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based...
$305.00
ISPE Baseline Guide: Volume 5 - Commissioning and Qualification International Society for Pharmaceutical Engineering / 2001 ISBN: 1931879060 This Guide provides advice and guidance that may be applied to all types of facilities, utilities, and equipment found in the healthcare industry. The Guide has incorporated comments from industry representatives from all areas and disciplines, FDA Field Investigators, and personnel from the FDA's Center for Drug Evaluation and Research (CDER)....
$202.50
ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance International Society for Pharmaceutical Engineering / 2005 / 92 pages ISBN: 1931879435 For processes that are conducted at multiple sites, there are clearly advantages to all participants using the same suite of software systems. The implementation of these multi-site computer systems can be very difficult, and for regulated systems, validation issues add an extra layer of complication. The GAMP® Good...
$232.50
ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities International Society for Pharmaceutical Engineering / 2004 ISBN: 1931879095 The Biopharmaceutical Manufacturing Facilities Baseline Guide may be used by industry for the design, construction, commissioning, and qualification of new facilities for the manufacture of biopharmaceutical Active Pharmaceutical Ingredients (APIs). The appendices consider non-U.S. regulatory differences, with input by ISPE Members from...
$202.50
ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance International Society for Pharmaceutical Engineering / 2005 / 128 pages ISBN: 1931879427 The validated status of GxP applications that are dependent upon an underlying IT Infrastructure is compromised if that IT Infrastructure is not maintained in a demonstrable state of control and regulatory compliance. The consequences of the IT Infrastructure being out of effective control can be significant. Depending on the...
$202.50
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 1 - Product Realization using QbD, Concepts and Principles International Society for Pharmaceutical Engineering / 2011 / 188 pages ISBN: 9781936379224 Part 1 includes the topics of Criticality, Design Space, and Control Strategy and addresses product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches.
$232.50
ISPE Baseline Guide: Volume 1 - Active Pharmaceutical Ingredients (Second Edition) International Society for Pharmaceutical Engineering / 2007 / 188 pages ISBN: 1931879559 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, such as: ICH Q7 ICH Q9 GAMP 4 21 CFR Part 11...
$202.50
ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5 International Society for Pharmaceutical Engineering / 2010 / 216 pages ISBN: 1931879680 During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to maintain compliance. This Guide highlights the importance of the operation phase of the system lifecycle, when the return on investment for...
$232.50
ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms Edition: 2nd International Society for Pharmaceutical Engineering / 2009 / 188 pages ISBN: 1931879672 This revision - the latest ISPE publication reviewed by the US FDA - updates content from the original Oral Solid Dosage Forms Baseline® Guide to current industry standards, practices, and regulatory requirements. Specifically, it addresses the latest interpretation of GMP requirements, as well as a risk-based approach to...
$232.50
ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Edition: 1st International Society for Pharmaceutical Engineering / 2010 / 186 pages ISBN: 1931879974 The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) provides a scientific risk-based approach based on ICH Q9 to manage the risk of cross-contamination to maintain product quality and operator safety. This allows the selection of the appropriate risk control...
$232.50
ISPE Baseline Guide: Volume 4 - Water and Steam Systems, Second Edition Edition: 2nd International Society for Pharmaceutical Engineering / 2011 / 264 pages The Water and Steam Systems (Second Edition) is the only comprehensive guidance of its kind and aims to assist with the design, construction, operation, and maintenance of new water and steam systems that meet current Good Manufacturing Practices (cGMPs) and comply with existing regulations and related guidance. New chapters covering...
$202.50
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 - Product Realization using QbD, Illustrative Example International Society for Pharmaceutical Engineering / 2011 / 232 pages ISBN: 9781936379231 Part 2 presents the small molecule case study developed by the ISPE PQLI® teams. This case study provides details of the application of the approaches to product and process understanding using quality risk management. Part 2 also...
$202.50
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 3 - Change Management System as a Key Element of a Pharmaceutical Quality System International Society for Pharmaceutical Engineering / 2012 / 56 pages ISBN: 9781936379460 This Guide aims to provide descriptions of good practices for change management. The modern pharmaceutical quality system described in ICH Q10 is a holistic approach which helps to facilitate the consistent...