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What are the key criteria that make an active pharmaceutical ingredient (API) factory succeed in today’s market?
ChemWerth has spent the last 35 years revising the answer to that question. Understand, it needs to be put into context in an industry that is constantly evolving. The answer we come up with today is much different than our answer five years ago and will most likely be much different than the answer we give in the next five years. However, one theme has not changed. In fact, it is becoming more important year after year — compliance.
We should agree that without a compliance strategy, you may as well change industries. The reality is that the bar is always being raised and will most certainly rise again. The question is — do you have a foundational strategy in place that can adapt to the often changing regulatory landscape? Is your strategy reactive or proactive?
Increased
regulation
GDUFA
II (short for Generic Drug User Fee Amendments II) has just come out and the US
Food and Drug Administration (FDA) is focusing on data integrity. The China
Food and Drug Administration (CFDA) has publicly stated it will crack down on
non-compliant manufacturing sites while the EDQM (short for European
Directorate for the Quality of Medicines and Healthcare) audits are focused
almost entirely on processes. Our customers are now actively pursuing their own
environmental health and safety (EHS) audits and are adopting a proactive
approach.
We have seen more factories being shut down, receive warning letters and be put under import alert over the last 18 months than ever before. This can be good or bad, depending upon where you stand on this issue, your commitment to compliance and how important the US and your domestic market is to your business.
Rising
costs of developing drugs
The
cost of drug development increased dramatically when GDUFA introduced the need
to run three exhibit batches. The finished dosage companies are now spending 3X
more for API than they did only two years ago. These companies want to have
confidence in the factory they choose, knowing they will be able to meet the rigors
and the new compliance standards.
With this in mind, the finished dosage companies — our customers — are now going to audits with up to four people in many cases. Two people to run the typical six system type audit, one to evaluate data integrity and one to evaluate EHS.
Many of these companies have taken the step begin running audits prior to committing to a project — it is that important. This will trickle down to the small and the medium sized companies as well. Why? Because they will realize the cost of not auditing the factory prior to starting a project is too risky, costing time and money.
Non-compliance
= Elimination
So,
what does this mean to you? It comes down to simple mathematics. If you are a
factory that commits to compliance, it will equate to more business. This is because
most factories that do not commit to compliance will be eliminated in the first
round by the customers, with the remaining eventually receiving warning letters
from the USFDA, or being shut down by the CFDA. This results in less factories
supplying the market with API and more business for your company.
Every year, since 1998, ChemWerth has hosted a two-day current good manufacturing practices (cGMP) training seminar in Shanghai, China. Open to all ChemWerth partner factories, the two-days are spent reviewing updates on FDA guidance, common FDA findings, data integrity, compliance and cGMP standards. Actual case studies are reviewed to practice determining the correct course of action and emphasize the importance of supply chain integrity.
This seminar was implemented 18 years ago with one objective — routine compliance. ChemWerth takes a proactive approach routinely to make sure a factory has the support and guidance it needs 365 days a year — an objective we highly value. With your presence at this seminar, it shows your commitment to compliance and quality.
— Edited version of a speech made by Ed Vanderbeck, COO, ChemWerth, during a two-day cGMP training seminar held in Shangai, China (Nov 3 to 4, 2016).
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