July / August 2011

July / August 2011 Cover


Quality Risk Management (QRM) Tool Selection: Getting to Right First Time
by Kristin S. Murray and Stephen Reich
This article presents how the quality and utility of Quality Risk Management (QRM) may be highly influenced by the selection of risk management tools. Tangible job aids and methods that have been proven to facilitate right-first-time tool selection are presented.

Manufacturing Systems Solution - More than Manufacturing Execution System (MES)
by Gilad Langer
This article presents a three phased approach to implementing a Manufacturing Systems Solution using real life examples to demonstrate the benefits.

Computer Aided Process Engineering at Chemagis
by Wayne Genck, Michal Hasson, Efrat Manoff, Roberto Novoa, and Moshe Bentolila
This article presents a detailed analysis of how one generic pharmaceutical manufacturing company implemented computer aided process engineering for process development, design, and scale-up from the beaker to the plant.

Validating Data Migrated onto Information Technology (IT) Systems
by Mark Nightingale
This article presents a comparison of sampling methods used to validate data migrated onto IT systems.

Industry Interview Series: Grace McNally, Senior Policy Advisor, FDA CDER Office of Compliance, Division of Manufacturing and Product Quality
by Rochelle Runas, ISPE Technical Writer
A visible player in the development of FDA’s 2011 Final Guidance on Process Validation, Grace McNally shares her experience on the effort it takes to shape such policy and her perspective on the Guide’s key recommendations.

Controlling Service Oriented Architectures in Support of Operational Improvement
by David Stokes
This article presents an approach to leverage GAMP® good practices to facilitate the qualification and validation of IT middleware and Service Oriented Architecture in support of efficient business operations.

Online Particle Size Analysis for Optimal Spiral Jet Milling
by Alon Vaisman
This article examines the principles of operation of industrially important mills and how real-time laser diffraction particle size measurement facilitates optimization and automated control.

Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part I
by Andrew Walsh
This article reviews the history of Cleaning Validation Acceptance Limits for Active Pharmaceutical Ingredients (APIs) and identifies where the currently used industry limits came from.

Practical Application of Quality Risk Management to the Filling Process of Betamethasone Injections
by Rodolfo Díaz, Germán Fernández Otero, and Cristian Muzzio
This article presents risk analysis performed on the Betamethasone Injections filling process and the conclusions obtained from the analysis.

ISPE GAMP COP Annex 11 Interpretation
by Winnie Cappucci, Chris Clark, Tim Goossens, and Sion Wyn
The ISPE GAMP Community of Practice (COP) provides its interpretation of the revised EU GMP Annex 11 Computerised Systems and consequential amendment of EU GMP Chapter 4 Documentation.