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In Pharma, Quality is Everything. All Else is Secondary.

We are firm believers that quality is more important than…well…everything in the pharma business. It’s very simple: in this highly-regulated industry, without quality – a company has no value.

We were recently featured in an article in Pharmaceutical Manufacturing titled ‘No-Compromise APIs – Hyderabad-based API provider Neuland Labs sheds the stigma of Indian manufacturers by building stringent quality control into every process.’

For us at Neuland quality is an obsession, as the article points out. As global pharma suppliers, we don’t put much stock into the perception that Indian pharma – or Chinese pharma (or any other particular region, for that matter) – is necessarily weak or subpar. For us, it’s a supplier issue…not a geopolitical issue.

The Cost of Outsourcing

The decision to outsource in the pharma and biopharma business is driven by one factor, and one factor only: cost. Everything else – from facilities & infrastructure, to developing & implementing a quality-driven mindset, to the collective team experience of having worked with hundreds or thousands of diverse compounds – all of those things can be acquired, given enough resources. It often simply isn’t cost-effective to do so.

So the decision to outsource is virtually always cost-driven.

But choosing whowhich contract pharma provider – to turn to is driven by all of those other things that I mentioned above:

  • Does the provider have sufficient facilities?
  • Do they have the technical processes needed?
  • Do they have deep working knowledge of my class or specific type of compound?
  • What are the timelines?

Floating above all of these questions aimed at finding the supplier who is a good fit is quality:

  • What is the supplier’s regulatory track record?
  • How robust are their quality systems?
  • What is their quality adherence mindset?

So yes – the supplier must be able to scale a product accordingly. They must have the infrastructure and skills needed in whatever niche space the sponsor occupies. But the number one most important factor, given the highly-regulated environment we operate in? Quality.

That’s been our experience as a global provider. Since 99% of our products are exported to the U.S., Europe and Japan, we’ve always been keenly aware of quality. Our earliest FDA inspection occurred in 1997 – one of the first in India.  In the article, our head of manufacturing operations – Pradeep Kumar Jain – is quoted at referring to Neuland as “a non-compromising organization” when it comes to quality. That mentality – at the core of what we do – is a key reason we’ve never once received a critical observation from any regulatory or customer audit.

Pradeep also said “production done without GMP compliance and quality in mind does not have any value to Neuland Labs or our customers” – a great reflection of our absolute insistence on quality.

You can read the article here: No-Compromise APIs

 

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