Driven in part by consumer demand, a better understanding of heavy metals and the ever increasing global manufacturing of pharmaceuticals, the regulatory landscape is poised to change dramatically.
It isn’t just pharmaceuticals. Dietary supplements, cosmetics and consumer products (to name a few) are all industries experiencing increased regulatory oversight of heavy metals.
However, regulatory compliance may not be the biggest issue. In today’s self-publishing world, news (warranted or not) travels like wildfire. We’ve all seen mega-brands brought to their knees by a groundswell on the Internet.
Today – safety and quality are a competitive advantage AND a necessity to protect your company and your brand.
In many cases, third-party heavy metals testing may be one of the most cost effective ways to evidence quality and protect your brand. Heavy metals testing has come a long way in the last decade.
Having participated in a number of workshops dealing with heavy metals (Sponsored by USP) over the last several years, I will offer that the proposed changes would seem to be an advantage to the industry. Let me explain…
The current method (general chapter 231) is based on 100 plus year old technology. The results can be subjective. The proposed methods will allow pharmaceutical companies to do the following:
- Analyze for heavy metals as significantly lower levels
- Quantify the results at ppb levels (parts per billion)
- Do so with quick turnaround times and very competitive prices
We are all aware of the current environment. The media has taken an ever critical role of pharmaceutical and nutraceutical companies. Historically, these industries have been given an “automatic pass” by consumers. If it was prescribed by a doctor or a vitamin on the shelf, everyone just knew it had to be good.
I think we all know times have changed. Pharma and nutra companies are no longer given that “automatic pass”. Metals, even at extremely low levels are being questioned by consumers and regulators.
Having the ability to evidence a comprehensive and quantifiable third-party testing program should be viewed as the most cost effective insurance a pharmaceutical lab can buy.
For this reason, many of our more progressive clients (Pharma and Nutra) have taken a proactive stance in terms of heavy metals testing. We applaud them. If you are interested in learning more about establishing a comprehensive third party testing program, let us know!
To learn more about heavy metals testing, contact us or request a quote now.
About Frontier – Frontier Global Sciences is an internationally recognized analytical laboratory, specializing in the analysis of trace metals or heavy metals in industrial, environmental and consumer applications. For over 18 years the company has provided innovative solutions and “gold standard” analytical services to corporations and government entities throughout the world.
