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Challenges in New Quality Concepts
by Nilesh Mohachkar, Xiaoyan Jia, and Yiling Ma

This article presents challenges in the implementation of ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality Systems, ICH Q11 Development and Manufacture of Drug Substance, and product lifecycle management in line with ISPE’s PQLI Guide Series.
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Global Regulatory News



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Multi-Purpose Plants for API Production
by Kazuo Tozaki, PE

This article summarizes the different types of multi-purpose plants and clarifies the issues involved in their design.
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Rapid Increases of Key Regulators Precede the Increased Production of Pharmaceutically Valuable Compounds in Catharanthus roseus
by Noreen F. Rizvi, Sheba Goklany, Erin J. Cram, and Carolyn W.T. Lee-Parsons

This article was adapted from a research project that was presented at the ISPE International Student Poster Competition during the 2012 Annual Meeting. It was a finalist from the ISPE Boston Area Chapter.
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Pharmaceutical Engineering Biotech Supplement Digital Edition



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Impact of Facility Layout on Developing and Validating Segregation Strategies in the Next Generation of Multi-product, Multi-phase Biopharmaceutical Manufacturing Facilities
by Mark F. Witcher, PhD

This article describes how the facility's layout impacts the process and product segregation strategies required to provide validated separation of products and processes throughout the manufacturing lifecycle.
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Design Features and Elements of Process Manifold Rooms
by Joseph R. Hettenbach, P.E.

This article describes the design features and elements that need to be considered for process manifold rooms.
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Packing Line Power Use and Heat Gain
by Martin Wheeler

This article discusses three approaches used to reduce energy usage in pharmaceutical processes.
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The Application of GAMP 5 to the Implementation and Operation of a GxP Compliant Clinical System
by ISPE GAMP Community of Practice

September 2013; A Concept Paper
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Global Regulatory News


This article describes a groundbreaking ISPE initiative that will help move the pharmaceutical industry toward the “desired state” and address the problem of drug shortages by defining objective quality metrics to support a risk based inspection program.
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ISPE Quality Metrics Project
by Christopher J. Potter on behalf of ISPE’s Quality Metrics Project Team

This article describes a groundbreaking ISPE initiative that will help move the pharmaceutical industry toward the “desired state” and address the problem of drug shortages by defining objective quality metrics to support a risk based inspection program.
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The Culture of Quality
by Randolph Fillmore

This article summarizes discussions on quality that took place throughout the ISPE Second Annual Conference on Redefining the "C" in CGMP.
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Quality Risk Management to Deliver Therapeutic Benefit: A Holistic Approach
by Jaspreet Gill

This article presents a summary of a presentation on a holistic approach to Quality Risk Management by Jaspreet Gill, Vice President of Global Quality and Compliance at Baxter.
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GAMP 21 Years Later
by David Selby

In this special Online Exclusive GAMP 21st Anniversary commemorative article, founding chair David Selby and other GAMPers give a personal view of the history, the present, and the future of the GAMP COP.
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The State of Quality by Design for Generics
by Chris Potter, ISPE PQLI Technical Project Manager, and CMC Pharmaceutical Consultant
September/October 2012
This article is a report on the joint ISPE - European Generics Association Meeting on applying QbD to development and manufacture of generic medicines.
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Resource Scheduling in QC Laboratories
by Rafi Maslaton
September/October 2012
This article presents the various aspects of scheduling in QC laboratories.
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Bringing New Products to Market Faster
by Adam Fermier, Paul McKenzie, Terry Murphy, Leif Poulsen, and Gene Schaefer
July/August 2012
This article presents ideas, concepts, and prototype experience on how to bring products faster to market through a more structured and integrated management of product, process, and analytical data based on proven industrial standards (S88/S95) and data warehouse technology.
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Administration of Quality Standards and Registration of Pharmaceutical Excipients in China
by Ling Su, Jingyi Leung, and Phoon Bee Lim
January/February 2012
This article presents the definition of pharmaceutical excipients, pharmaceutical excipient standard and categories, pharmaceutical excipient submission requirements, and imported pharmaceutical excipient registration procedures in China.
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Facility of the Future
by Active Pharmaceutical Ingredients Community of Practice (API COP)
January/February 2012
This article presents a perspective on what the Facility of the Future will look like as envisioned by ISPE’s API community. The concepts in the article will form the basis of a series of planned ISPE Guidance Documents.
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Resource Planning in QC Laboratories
by Rafi Maslaton
January/February 2012
This article presents a methodology and approach to resource planning, including both analysts and instruments in QC laboratories.
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Applying Fault Tree Analysis (FTA) as a Top Level Risk Management Tool in Software Development
by Paul Noble, PhD
January/February 2012
This article presents the case that fault tree analysis is the better risk analysis method to apply early in software development projects.
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Control Strategy as the Keystone of the Product Lifecycle, from Product/Process Understanding to Continuous Process Verification and Improvement
by Johanne Piriou, Bernard Elissondo, Michel Hertschuh and Roland Ollivier
January/February 2012
This article presents the general principles of Control Strategy (CS) and its evolution. A method for designing a CS and its filing in Common Technical Document (CTD) format are proposed. CS within the continuous process verification and product lifecycle is discussed.
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Global Regulatory News

January/February 2012

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A Risk Assessment Approach to Planning an API Production Facility
by Kazuo Tozaki
January/February 2012
This article presents a new risk assessment table and discusses associated issues, including the targets of assessment, criticality, contents of the risk factors, and severity.
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Inhibitory Effect of Silkworm Extract on Alpha-Glucosidase Activity and Postprandial Blood Glucose in Mice
by Juan Cueva, Patricio Castillo, Giovanna Allara-Salice, and Angel Guevara

This article was developed from the presentation by a finalist in the ISPE 2010 Undergraduate International Student Poster Competition.
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Inhibitory Effect of Silkworm Extract on Alpha-Glucosidase Activity and Postprandial Blood Glucose in Mice
by Juan Cueva, Patricio Castillo, Giovanna Allara-Salice, and Angel Guevara
November/December 2011
This article was developed from the presentation by a finalist in the ISPE 2010 Undergraduate International Student Poster Competition.
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Global Regulatory News

July/August 2011

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Influence on Drug Manufacturers and Drug Distributors with Promulgation of the Tort Liability Law of the People’s Republic of China (PRC)
by Ling Su
July/August 2011
This article presents the drug quality tort liability of drug manufacturers and drug distributors in China and reviews the related provisions of the Tort Liability Law.
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Practical Application of Quality Risk Management to the Filling Process of Betamethasone Injections
by Rodolfo Díaz, Germán Fernández Otero, and Cristian Muzzio
May/June 2011
This article presents risk analysis performed on the Betamethasone Injections filling process and the conclusions obtained from the analysis.
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Global Regulatory News

September/October 2011

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Global Regulatory News

March/April 2011

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Business Process Management (BPM) Based Pharmaceutical Quality Management Systems: A Win-Win Between Compliance and Competitiveness
by François Versini
January/February 2011
This article shows how a BPM-based Quality Management System optimizes the way to comply with today’s evolving processes and stay competitive in the marketplace.
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Achieving a Validated Facility from a Set of Critical Quality Attributes
by Magnus Jahnsson, Firas Al-Saffar, and Anna Kälvemark
January/February 2011
This article presents a risk-based work flow for design and validation of facilities, turning a set of Critical Quality Attributes into a validated facility. The main objectives are to improve quality assurance and traceability while saving cost and time.
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Case Study: Application of the ISPE Baseline Guide for C&Q Yields Cost, Quality, and Budget Control
by Robert A. Young and Humberto Rosas
January/February 2011
This case study provides an example of the positive results that can be obtained by the following principles set forth in the ISPE Baseline Guide® for Commissioning and Qualification, Volume 5.
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ISPE Update – Additional Information on The New and Improved Pre-Approval Inspections Program
by Rochelle Runas, ISPE Technical Writer
January/February 2011
- Investigator’s Perspective of the New PAI Compliance Program - Reviewers on Inspection – An ONDQA Perspective - An Industry Perspective on a Joint Inspection - Q&A with FDA
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Global Regulatory News

January/February 2011

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Prevent Counterfeiting in the Pharmaceutical Industry
by Janice Abel

Many companies now deploy specialized packaging, applications, and other anti-counterfeiting technologies to help prevent counterfeit products, protect brands, protect customers, and allow rapid and effective response to counterfeit products. ARC would be interested to learn what steps, if any, your company takes.
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2010 Scope of Practice & Compensation Report for the Regulatory Profession


Regulatory Affairs Professionals Society (RAPS)
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Global Regulatory News



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Design, Validation, and Control of Sterile Manufacturing Facilities: A Brief Overview from the Perspective of Risk Management and Existing Regulations
by Ana Quinto , Prof. Jose Menezes

This article presents the design, validation, and control of sterile manufacturing facilities; discusses the implementation of risk management, and provides an overview of existing regulations.
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A Simplified Statistical Model to Assess Product Capability
by Mr. Selim Seyhan, Mr. Tolga Ozcan, Mrs. Merve Oktem

This article presents a simplified model that can be used after future refinements to identify the specific process capability in pharmaceutical manufacturing. Data for a concrete production stage of a solid product is presented. Technologies, present and future, are identified.
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Systems Turnover Coordination: Effective Application and Integration of the Supplier-Provided Engineering Turnover Package (ETOP)
by Ms. Carol Susla

This article presents the process for leveraging supplier knowledge and documentation in the context of applying a risk-based approach to compliant commissioning and qualification programs.
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Industry Meets Regulators for PQLI Update in Strasbourg
by Dr. Kate McCormick

This article presents the key messages from the presentations and conclusions from the PQLI workshops held in Strasbourg in September.
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Case Study: Risk-Based Approach to Containment and Control for Potent/Hazardous Compounds
by Hisao Takahashi, Mr. Shigehito Nakamura

This case study reviews an approach to containment and control and provides practical countermeasures to prevent cross-contamination from potent or hazardous compounds in pharmaceutical integrated manufacturing facilities.
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China Pharmaceutical Intellectual Property Protection Reform – Review of the Medicine-Patent Related Provisions in the Draft Patent Law of the People's Republic of China
by Dong Zuojun, Huang Wenlong

This article presents patent, genetic resources, medicines compulsory licensing, parallel importation, and bolar exceptions.
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A Regulator's Perspective of His GAMP Experience
by Anthony Trill

.
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Global Regulatory News



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Regulatory News, May/June 2009 Pharmaceutical Engineering



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China State Food and Drug Administration (SFDA) – Responsibilities, Internal Structure, and Affiliated Organization


by Jason Tang
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Global Regulatory News



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A Risk Assessment Approach to Planning an API Production Factory
by Kazuo Tozaki

This article presents an overview of the planning of an API production factory from the risk assessment viewpoint. Three risk assessment factors of severity, probability of occurrence, and detectability are discussed. An example of conceptual layout planning is presented.
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Working Height Velocity Measurement in Conventional Cleanrooms
by William Mason, Bernard McGarvey, Thomas R. Spearman

This article presents the methods and results from performing Working Height Velocity studies in conventional cleanrooms.
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Electro Membrane Technology Boosting Bioreactor Processes
by Mr. Rene Fuhlendorff, Arvid Garde, Jens-Ulrik Rype

This article presents electro membrane technology for improving yield of bioreactor processes.
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Introduction to ICH: Essential Background to PQLI
by Kate E. McCormick


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Barrier Isolation History and Trends – 2006 Data
by Jack Lysfjord, Michael Porter

This article provides history and trends for automated fill finish for injectable drugs utilizing isolator technology.
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GAMP 5 Debuts to a Record Breaking European Audience
by Gail Evans


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