September / October 2014 Cover


Symposium Summary Report: The Use of Process Capability to Ensure Pharmaceutical Product Quality
by Daniel Y. Peng, Richard Lostritto, Dafni Bika, Jean-Marie Geoffroy, Thomas Shepard, Brian Eden, Kenneth Coté, Alpesh Patel, Michael Choi, and Lawrence X. Yu
This article presents summary report of the main points from the 28th IFPAC Annual Meeting Process Capability Symposium.

The Use of Process Capability to Ensure Pharmaceutical Product Quality
by Thomas Garcia, PhD, Roger Nosal, and Kim Vukovinsky
This commentary is in response to the symposium summary report featured in this issue. Positive aspects of the report are presented in addition to areas requiring further clarification, the impact of process capability on specification limits, the relationship between QbD and process capability, and the desire for regulatory flexibility. In general, this commentary is intended to constructively progress these topics toward a meaningful outcome.

Investigation of New Level Technologies in Single Use, Disposable Systems
by David Ladoski and Dan Klees
This article presents guided wave radar level measurement as an acceptable, less expensive alternate to load cell systems.

“Paper on Glass” User Centric Batch Operations – A Productivity Game Changer for Paper Driven Pharmaceutical Production
by Robert Harrison
This article presents how technology has advanced electronic batch record into solutions which compete one-to-one with paper flexibility, opening the door to game changing production efficiencies in pharmaceutical production.

Pharmaceutical Engineering Interviews Chi-Wan Chen, Executive Director Global CMC, Pfizer
by Linda Evans O’Connor and Jean Poulos
Chen discusses possible regulatory changes in China, the impact of these changes on various guidance documents, and the evolution of CFDA’s draft comment process.

Pharmaceutical Engineering Interviews François Sallans, Chair of ISPE’s Drug Shortages Initiative Team
Sallans talks candidly about the objective of ISPE’s Drug Shortages Prevention Plan, including lessons learned from the survey, the importance of a corporate quality culture, and the role metrics can play in preventing shortages.

Incorporating Lean Principles into Pharmaceutical QC Laboratory Design
by Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka
This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design.

A Framework for Implementing Stage 3 Continued Process Verification for Legacy Products
by Bikash Chatterjee and Wai Wong
This article presents a method to account for missing information and provides recommendations to understand a legacy product and how to apply the three stages of the new guidance to satisfy the FDA and other regulatory agencies.

Regulatory Mythbusters – Sorting Fact from Fiction
by David Churchward, Ron Ogilvie, Bryan Wright
The authors tell us that there are GMP-related “myths” created and propagated through industry. These myths may be created for a variety of reasons – regulatory changes, perceived regulatory inconsistencies, and regulatory misinterpretation. In this article, several myths are “busted” and better communication with regulators is recommended to help prevent future myths from rising.

In This Issue