Lost in Translation?
Can QbD translate to jobs in the pharmaceutical industry?
■ By Girish Malhotra, PE, EPCOT International
In recent news we have read that some of the major pharmaceutical companies are getting out of, or realign- ing their API manufacturing. This can mean that we are going to loose additional jobs. In the last few years about
150,000 jobs have been lost. Pharmaceutical companies have
been increasingly acquiring their API needs from the developing countries. Up until about ten years ago members of SOCMA
(Society of Chemical Manufacturers and Affiliates) and ECFG
(European Fine Chemical Group) used to manufacture many
APIs. Their volume has been decreasing, with increasing
amounts being sourced from companies in China or India. The
justification for this has been cost.
Companies in the developed countries could have retained
API manufacturing provided they were technologically aggressive and cost competitive. Now, through their associations,
they want to use regulations to curtail imports and
the strategy could backfire (1). This article, in
brief, discusses how companies, by incorporating QbD practices, can become
competitive again and bring jobs
home. This article will focus on
APIs but the observations can apply to formulations also.
In a recent magazine article,
Quality by Design (QbD)
was labeled as a technology
that will improve product
quality. Other magazine ar-
ticles labeled PAT (Process
Analytical Technology) and
continuous processing as
new technologies. These
connotations to many pur-
ists in manufacturing and
quality management would
be like saying the earth is flat.
PAT is a recent, but fancy name,
for known analytical methods and
tools used in process development
that have been around
for at least fifty years
or more. Continuous
processing has been
around for about the
same period. It seems
that in the pharma
world a new spin has
been put on known and proven practices.