Pharmatech Associates articles: technical expertise for the regulated life science industry

Bikash Chatterjee writes, in the latest Regulatory Forum column in Controlled Environments magazine, that realizing the promise of personalized medicine requires a shift in the way the pharma/biotech industries define quality, efficacy, and safety in personalized drug therapies as well as their companion diagnostics. 

The FDA continues to refine its position on Companion Diagnostics and is working on more detailed guidance. Chatterjee warns that the agency will also have to consider the broader implications of Laboratory Derived Tests (LDTs).

Excerpts from Chapter 2 (titled Trouble in Paradise and Catalyzing Change) of Bikash Chatterjee’s new book,” Applying Lean Six Sigma in the Pharmaceutical Industry,” are reproduced by permission of the author and publisher. 

The book is published by Gower Publishing, Ltd., ISBN 978-0-566-09204-6

Contract Pharma magazine has included a link to a sample chapter (discussion of Deming's 14 Points), and will review the book in Q3.

Article in Controlled Environments magazine by Bikash Chatterjee of Pharmatech Associates, highlighting the FDA's efforts to bridge the gap between brand drugs and generics, in terms of quality and efficacy.

In the Regulatory Forum column of Controlled Environments magazine, Bikash Chatterjee of Pharmatech Associates writes about the FDA's proposed rule that would speed the dissemination of new safety information about generic drugs to health professionals and patients.

A new article in the April 2015 issue of Pharmaceutical Technology magazine by Mark Mitchell, Pharmatech Associates, describes how to use process validation design data to establish process performance qualification acceptance criteria, in drug manufacturing. Mitchell clarifies what seem to be difficult and abstract concepts, using practical examples.

January 2015 article in Pharmaceutical Manufacturing magazine, by Bikash Chatterjee, Pharmatech Associates.

In this era of globalization, the supply chain for genuine pharmaceuticals has grown longer, and every step in the chain offers another opportunity for counterfeiters. Pharmaceutical companies and governments worldwide believe that counterfeiting can be reduced significantly by implementing product serialization. Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain, from production to distribution.

Last month, Gower Publishing released the book “Applying Lean Six Sigma in the Pharmaceutical Industry,” by Bikash Chatterjee, President and CTO of Bay-area based Pharmatech Associates. Chatterjee has worked in pharma applying the principles involved for more than two decades in over 30 countries.  He shared some of his thoughts on the place of Lean in pharma and biopharma.

Full article at: http://www.contractpharma.com/issues/2014-09-01/view_features/newsmakers-lean-six-sigma-and-seeing-the-forest-behind-the-trees/#sthash.qX4da4el.dpuf

The public assumes our drugs are safe and effective but the FDA is in a difficult position to send a consistent quality message to the industry when it has to deal with potential drug shortages on a case-by-case basis. A strategic plan by FDA is a solid step toward establishing systems that provide early warning to avoid shortages.

Article by Bikash Chatterjee, Wai Wong and Peter Rafa, of Pharmatech Associates  in Pharmaceutical Processing - April 2012.

In January 2011 the FDA issued its new guidance on Process Validation (PV). The new PV guidance uses the basic principles of scientific understanding put forth in ICHQ8—the foundation of Quality by Design (QbD)—to establish process understanding and link it to product reproducibility. It effectively abandons the old concepts of demonstrating process validation and replaces it with a new, structured approach.

It formalizes these principles by describing the level of product and process understanding necessary to satisfy the requirements of Stage 1 of the new PV guidance. To achieve this level of process understanding a framework that integrates product performance as part of process characterization is required. So simply put, the new PV guidance will make it much easier to justify moving toward QbD.

The challenge that many industry personnel face is bridging the gap between the former validation approach of “three batches and we’re done” to understanding how the new PV stages work together to establish process predictability.

In practical terms, the new PV guidance describes the three stages as follows:

Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.1

Predictability is the guideword.

Pharmatech has established a framework that generates the necessary information to satisfy the new PV structure and provide a manageable plan.