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30 Minute Interview
'GLP compliance costs money'
Known for his expertise on regulatory compliance, Dr Ludwig
Huber, Compliance Fellow of Pharmaceutical Solutions Unit, Agilent Technologies
talks to Sapna Dogra on identifying and evaluating compliance-related
initiatives with the most potential to benefit customers.
Where does Indian Pharma industry stand with regard to
meeting laboratory compliance regulations?
India has two different situations. The first is compliance for Indian markets
and some Asian markets, and the other is compliance for US and European markets.
Therefore, companies that sell in international markets fulfill compliance regulations
because they have to compete with international companies that meet USFDA requirements.
Though I do not have much contact with companies that do not sell in US or Europe,
I have found that the their standards are much lower because they serve the
domestic, Asian or third world markets where standards are not very high.
Can you tell us about requirements for GCP, GLP, GMP compliance?
The first chapter on GMP, GLP and GCP compliance requirements elaborates on
manpower qualification. Then, companies have to get their equipment validated.
They also have to validate their methods and procedures. Companies have to comply
with electronic records and electronic signatures regulations for the trio.
I don't see much difference between them, at least not from a laboratory point
of view. But yes, definitely from manufacturing point of view or facility point
of view, there will be certain specific requirements in GCP, GLP and GMP peculiar
to them. While on one hand, there are few different requirements for manufacturing
and facilities, on the other there are certain requirements common to all.
Why is compliance rate so low in India?
There is no punishment if you don't comply with a regulation. So why would a
company do it? Hence, I believe in existence of enforcement. Coming to Indian
companies, they are not doing it because it costs money.
Companies, which export to the US or Europe, also manufacture and market certain
products and services for the Indian markets. These most often use the less
compliance approach just because it is cheaper.
The smaller companies that supply to Indian markets probably don't have the
necessary resources.
Kindly tell us about the use of electronic communication
in regulated atmosphere.
USFDA has come out with a new guidance on use of modern communication technology
for conveying important safety information. It has recognised that electronic
communication such as e-mail can significantly shorten the time between occurrence
of an event and public knowledge of the same.
Suppose a company sends out a drug and later it is found to have health or safety
problem it has to immediately stop selling that particular drug and this information
has to travel fast. Now, if the company uses a computer system, then they have
to comply with electronic records and electronics signature 21CFR part 11 of
FDA is a regulation on handling general electronic records and signatures.
What are your recommendations to the Indian Pharma industry?
I suggest Indian industry and regulatory agencies to attend
international conferences of task forces and be a part of various international
committees and schemes like the Pharmaceutical Inspection Convention Scheme.
In addition, the industry should continue to watch what's going on in the world
as there will be a point when it will be mandatory to implement global standards.
editorial@expresspharmaonline.com
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