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The third Part of our series on QbD and Quality Continuous Improvment

September 24th, 2017 by

We are happy to announce the publication of the third part of our series.  This article, co-authored with colleagues Dr. Ko and Dr. Stein covers how to create a sustainable continuous improvement program with an emphasis on QbD.  Happy reading.  The link is 


Part II of article “Big Data & Leadership Strategies For Enabling Quality By Design”

August 29th, 2017 by

Part 2 of a series of articles about Pharma implementation of new regulations and quality systems is out and available for viewing at a number of sites including  Happy reading.

The second part to our survey on implementation of Guidances on Company QMS

July 3rd, 2017 by

In the first article dealing with our surveys, we concluded that not all of the guidances issued had been implemented completely.  Even when they had been implemented, the implementation did not take advantage of all the potential.  For instance many companies were reluctant to  not work on certain technical areas even though their risk analysis indicated that these same areas were relatively unimportant and had little impact on product quality and patient outcome.  And why was that?  Perhaps they did not believe their analysis.  Perhaps they were afraid of inspectors disagreeing.

The second article (Part 2 of the survey) showed that even though guidances had been implemented, the impact on some of the most troublesome elements of the QMS was not as effective as hoped.  Some if you find your company not gaining as much traction as hoped, you are not alone in struggling to become more effective.

How well has the pharma industry implemented regulations?

February 25th, 2017 by

This has always been a question people ask.  As a consultant i see a slice of the industry that interacts and works with me, so I have my opinions.  However, a company that employs me may not represent the average company.  So a colleague of mine, Peiyi Ko, and I decided to conduct a survey asking these questions.  we used Survey Gizmo as the survey tool and LinkedIn Groups as the interface.  These 40 questions were posed and because of the interesting answers we got, we are publishing them in two parts.  This post has the first part published in Pharmaceuticalonline.  In this part, we examine the implementation of various guidances and regulations.  The second will feature how ell they have impacted the company Quality Management System.

The second part will be published in a couple of months.  Bookmark my website so you will see it when the next is posted.

Happy reading

EMA issues new annexes and guidances

June 21st, 2016 by

During the last few months the European Medicines Agency (EMA) has issued a series of revisions to Annexes and Guidances

Specifically, the following

Annex 15 – Validation and Qualification

Annex 16 – Certification by a Qualified Person and Batch  Release

Annex 17 – Real Time Release Testing

Guidance to Industry: Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

To understand what they contain and what it means, I refer you to an article I wrote recently in

Pharmaceutical on line  and

Bioprocess on line