Gordon Farquharson is a Chartered Engineer and Principal Consultant
with Bovis Lend Lease Life Science and Pharmaceutical Division based in the
UK. This founding member of the UK Parenteral Society is a past chair of
the ISPE European Education Committee and was voted ISPE Member of the year
2001. With 30 years of experience in engineering and consulting (API, Dosage
form & Devices), the affable Scot shared his experience and expertise
with the participants at ISPE Q7A symposium cGMPs for Sterile Active Pharmaceutical
Ingredients (APIs). He familiarized the attendees with the ICHQ7A and the
link with dosage form cGMPs for Sterile APIs. He provided a general understanding
of the regulatory aspects of APIs industry and basic knowledge on the primary
drivers for regulations in the APIs industry.
In an exclusive interview to The Pharma Review on the sidelines of ISPE Q7A
symposium at Hyderabad, Gordon Farquharson shared his thoughts on GMP practices
and the emerging Indian Pharma industry with Mr. Kishore Srirambhatla.
Excerpts from the interview
How difficult is the harmonisation process?
First of all it is important to understand that harmonisation is a very strong
goal for the manufacturers, customers, and prescribers of products. It is
equally important for individual governments or groups of governments' responsible
in framing regulations and guidelines. Historically, the United States, Europe
and Japan have produced to some extent very strong guidelines largely driven
by the size of their home markets. The World Health Organisation is also
a major contributor to international regulation and GMP guidance.
The problem is that all these guidelines have been written at different times
by different people. More so particularly, if we compare US regulations the
legal structures behind the codified regulations, are different from the
guidelines produced by WHO. I don't believe in my life time we will ever
see hundred percent harmonisation. But I see every year, pieces of the puzzle
improving and we get now very a common approach to sterile product manufacture,
very common attitude to validation and so on.
I think the attendees here in Hyderabad are concerned with the details because
the GMPs are quite philosophical. If you have attended the meeting in Hyderabad
this week you would have seen and heard lot of people discussing problems
of interpretation- not of principles but of details. So interpretation is
different from one engineer to another or one QA professional to another.
We have to manage and deal with this. It will get better, but in my lifetime
I don't see one world GMP.
What are the challenges? Why this scenario?
The challenges are partly governmental and partly national interests, some
protectionism and perhaps cultural differences. I don't know if you have
ever tried to sit along with ten people and write one letter which all agree
with. You try doing that with 26 nations and you will know some of the problems.
Are you referring to your earlier WHO assignment? How difficult was it?
The WHO assignment on Water GMPs was challenging. I think the lesson I learnt
is that if you join in and work in that sort of an environment you have to
realize that there will be 20 other people with a slightly different opinion.
And if you are writing, you have to be prepared to bend and adjust and try
to get inputs from other people. And so you have to do that. And also the
other big challenge is when trying to reach a consensus it is very easy to
make the words in the end say nothing. So you dilute everything to say nearly
nothing. The big challenge is still keeping the principles so that they are
strong and helpful.
Tell us about your experiences with Indian Pharma industry.
I have worked with a number of multinational companies and indigenous companies.
I and my colleagues provided GMP Consulting, evaluation of firms for compliance
with European and US regulations, and also project engineering for designing
new process plants and process equipment systems.
You have been very patient while answering queries during the interactive
sessions. What is emerging in the Indian Pharma industry?
The Indian manufacturing scenario is clearly a major power base for manufacturing
of medicines driven partly by low manufacturing costs and high educational
and manufacturing competence. Those two are the most attractive things. The
challenges I think are that Indian professionals still want the regulations
to tell them in detail and they need to learn. Which is why they come to
programmes like this and they need to take responsibility to evaluate and
decide on engineering details. And about the questions people ask, my role
in a meeting like this is to help share experiences so that people can learn
to do a good job and take it back to their factories on Monday morning.
Where does the Indian Pharma industry stand as far as GMPs are concerned?
The best in India is truly internationally competent and equal and I think
the worst if I can use that phrase would be at very low level. So you get
very broad spectrum. Indian firms who want to manufacture products of international
quality can compete in terms of manufacturing plants and operational excellence
and are as good as the best.
How do you put in a nutshell your 25-30 years of work and experience in
the field of GMPs?
To put that in a nutshell, the whole world whether it is emerging nations
or established nations in the healthcare field have seen GMP practices rising
both on the regulatory demand and the capability in the countries. What we
have seen in the last 15 years is huge acceleration here in India and also
in China you see some of the same things. As we heard from Mr. Reddy in the
keynote address, there are also so many challenges for the industry here
particularly indigenous firms are very small and fragmented. And that also
probably makes it difficult to invest in state-of-the-art as it demands larger
scale and is expensive too. And that is the next big challenge. We have seen
it in Europe. Pharma companies there got bigger and bigger through mergers
and acquisitions. Similar thing happened in engineering manufacturing in
Europe. And I guess similar thing must come here.
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