Category Archives: ISPE

ISPE Good Practice Guide: Operations Management

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Published by: 2016-01-01 / 2016-01-01 / 166 pages
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 Guide addresses all operations along the supply chain, from the selection of raw materials through to the distribution of final product.

The Guide helps save time and money by facilitating effective communication between lab owners, engineers and builders about the function, operation and design parameters that must be met.

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This publication is available only in printed edition.

ISPE Good Practice Guide: Technology Transfer

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Published by: International Society for Pharmaceutical Engineering / 2014-05-01 / 84 pages
The Guide also presents industry good practices for successful and efficient execution of technology transfer projects and to achieve a balance between risk management and cost effectiveness while aligning with applicable regulatory expectations. It covers the principles of technology transfer and also provides some tools for its practical application.

This Guide is intended to be used as a generic guide to technology transfer in combination with a compilation of information under three specific topics:

  • Analytical Procedures Technology Transfer
  • Drug Substance (Active Pharmaceutical Ingredients (APIs)) Technology Transfer
  • Drug Product (Dosage Forms Manufacturing Processes) Technology Transfer

The Guide is intended to provide an approach on how to perform technology transfer. Not all the activities described in this Guide will apply to every system. Organizations may select activities appropriate to the type and scale of technology tranfsfer being performed.

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This publication is available both in printed and PDF edition.

ISPE Guide: Biopharmaceutical Process Development and Manufacturing

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Published by: International Society for Pharmaceutical Engineering / 10/31/2013 / 228 pages
The ISPE Guide: Biopharmaceutical Process Development and Manufacturing focuses on the development and process approaches and practices involved in providing cost effective, regulated manufacturing of biopharmaceutical products in a timely manner that meet their intended use.

This Guide intends to present a universal roadmap for process development and manufacturing of biopharmaceuticals that provides practical, scientifically sound guidance that helps users incorporate good practice and insight in order to develop robust processes that produce safe and more cost effective biopharmaceuticals.

This Guide applies to the class of products that include protein therapeutics, monoclonal antibodies, and/or those cells or organisms that have been generated or modified by recombinant DNA/RNA, or other technologies to produce drug substance. It may also be applied to cell culture based vaccine products.

This Guide is intended to be used in the design, development, implementation, operation, quality control, and quality assurance of biopharmaceutical processes. This guidance should be useful to persons involved in these activities, including process development scientists and engineers;manufacturing, quality, and industry suppliers. This also includes regulatory personnel with a need to understand fundamental biopharmaceutical processes.

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This publication is available both in printed and PDF edition.

ISPE Good Practice Guide: Booklet Labels

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Published by: International Society for Pharmaceutical Engineering / 03/01/2013 / 42 pages
This Guide was written to create methods for standardizing the format, design and content of clinical trial booklet labels. Because booklet labels contain vital information for testing sites and subjects, the Guide enables more consistent use of booklet labels to reduce confusion and non-compliance.

In addition to suggestions for effective and compliant booklet label design, the ISPE Good Practice Guide: Booklet Labels includes recommendations and justification for placement of required information and whether it should be included on the label or elsewhere. This Guide is a valuable tool you can use to perform a gap analysis on your current processes and readdress them to:

  • Reduce/eliminate risks and concerns addressed by sites and regulators
  • Increase operational efficiency while ensuring subject safety
  • Reduce errors in design process, allow for printing standardization and reduce delays during distribution process
  • Reduce dispensing errors by sites
  • Allow subjects and staff to become familiar with label design, so they know where to look for information
    Allow for standardized training of sites and subjects in product handling, use of booklet labels and Use-by dates.
  • Reduce costs and delays due to destruction or re-labeling for products with extended expiry dates

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This publication is available both in printed and PDF edition.

ISPE PQLI3DLUS

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

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 development and production of high quality pharmaceutical products. The ISPE PQLI GPG: Change Management System describes potential product lifecycle approaches to the change management system element of a pharmaceutical quality system. These approaches can help to achieve the opportunities described in ICH Q10.

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This publication is available both in printed and PDF edition.

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 microbiological considerations, such as biofilm formation, use of sanitizers, sampling, testing, and control levels, as well as the overall impact of microbial considerations on unit operations and finished water have been added.

The Guide also has been reviewed by the US Food and Drug Administration (FDA), and their comments have been taken into consideration in the final version of the Guide.

The Guide was written by a global team of critical utilities experts with a combined experience of more than 500 years. Much of the team responsible for the original Water and Steam Systems Baseline Guide has returned to contribute to the revised Guide, providing continuity and longevity of vision to the Guide?s contents.

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This publication is available both in printed and PDF edition.

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

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 refers to the many case studies in the public domain and uses ICH guidelines Q8 (R2), Q9, Q10, together with other relevant ICH guidelines.

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This publication is available both in printed and PDF edition.

ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry

International Society for Pharmaceutical Engineering / 2011 / 282 pages

The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry provides good practice approaches which promote the successful integration of GxP with relevant project management activities to ensure that compliance risk is managed effectively and proactively.

The Guide discusses: the tools and techniques supporting project delivery, the life cycle of a typical project in the pharmaceutical industry, and how compliance to pharmaceutical industry regulations is integrated with the project life cycle.

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This publication is available both in printed and PDF edition.

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

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.

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This publication is available both in printed and PDF edition.

ISPE Baseline Guide: Volume 3 – Sterile Product Manufacturing Facilities, Second Edition

International Society for Pharmaceutical Engineering / 2011 / 226 pages

The newly updated ISPE Baseline® Guide: Sterile Product Manufacturing Facilities is a complete revision of the original version, and contains recommendations to help facilitate compliance with the latest FDA and EMA guidance. The update is aimed at a truly international audience, as it incorporates a comprehensive tabulation, explanation, and comparison of the cleanliness designations found in FDA, EMA, and ISO guidance documents, allowing for better harmonization in global facility design and a wider breadth of regulatory compliance internationally. Technical updates contained in the Guide include the use of RABS and isolator technology; facility design; best practices for terminally sterilized and aseptically processed sterile products; and updated guidance on quality attributes of construction and finishes solutions for different grades of facility. The Guide includes informative diagrams and thorough text to explain and compare GMP requirements, providing a platform for developing compliant solutions and allowing firms to follow several different routes to reach a compliant solution. The new Sterile Product Manufacturing Facilities Baseline Guide consolidates all of ISPE's latest best practice recommendations on sterile manufacturing facility design into one document.

Ordering and availability

This publication is available both in printed and PDF edition.