Quality Systems

Articles

Featuring software, parallel automated reactors, and other tools designed to facilitate design of experiments, development of the design space, and better process understanding and control, the Hyderabad facility came online on July 20

Neuland Laboratories Opens QbD-centered Process Engineering Lab

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

Using QbD in Topical Drug Manufacturing

The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.


Predictions from CPhI Annual Reports—How Accurate Were They?

Agnes Shanley is senior editor of Pharmaceutical Technology.

A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.

Will the Pharmaceutical Industry Ever Get to Six Sigma?

In implementing quality by design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.

Understanding How Excipients Affect Drug Quality

Elizabeth Hewitt is senior scientist I, Elizabeth.Hewitt@mpi.com,at Millennium Pharmaceuticals, Inc., 40 Landsdowne St., Cambridge, MA 02144, USA.

Patrick Johnson is an analytical chemist in analytical sciences/chemical development at GlaxoSmithKline in the UK.

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

Mark Argentine is a senior research advisor at Eli Lilly.

Qinggang Wang is a principal scientist at Bristol-Myers Squibb, qinggang.wang@bms.com.

Shreekant Karmarkar is a senior research scientist at Baxter.

Andrea M. Pless is an associate director at Teva

Zeena Williams is a senior associate director at Boehringer Ingelheim

Yanqun Zhao is Sr. Principal Research Scientist at AbbVie.

Ariane Marolewski is Sr. Director at Infinity.

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.

Evaluating Progress in Analytical Quality by Design

The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.

European Pharmacopoeia Publishes Chemical Imaging Chapter

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

European Pharmacopoeia Commission Concludes Biotherapeutics Pilot Phase

Wendy Saffell-Clemmer, BPS, is research director, R&D and innovation, at Baxter Healthcare.

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.

Analytical Method Validation Using QbD and QRM

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.