As you know, rules and regulations are a definite constant in this industry. Whether it’s a new one surfacing or another one changing, we know that you, as a customer, need to comply.
Doe & Ingalls thought it would be best to have Jai Murthy, [VP Strategic Business Development] from PHARMCO-AAPER share his thoughts on the subject and we can help our customers navigate through these new requirements.
First of all, what do the new mandates mean?
The new USP <232> and ICH-Q3D will ultimately require pharmaceutical manufacturers, API manufacturers and excipient suppliers to meet the more extensive testing and validation of their entire manufacturing process and supply chain. This will drive the need for industry improvements in cGMP-compliance and the use of higher quality raw materials within manufacturing’s critical processes.
Why the concern for heavy metals?
In the USA alone, the average American has become more aware of the probable “contaminants” present in pharmaceutical products. Their concerns include product shelf life, potential side effects and the presence of heavy metals. Because of this, consumers will no doubt, drive the need for more detailed information on the actual contents of all finished drugs, as well as the acceptable levels of undesirable elements contained within them. We’re already seeing it occur within the food industry as more stringent ingredient label laws come into play. It was only a matter of time before the attention turned to pharmaceutical products as well.
When is the expected implementation date?
While a date for the mandates have not been set for the implementation of ICH-Q3Dthe General Chapters for USP <232> and <233> on elemental impurity limits and procedures are currently scheduled for implementation in December of 2015.
What has PHARMCO-AAPER done in anticipation of the new mandates?
In anticipation of the mandates passing, PHARMCO-AAPER has already begun testing for the presence of heavy metals in its solvent line. We are also able to provide documentation to customers, helping them be in compliance.
If you need more information on this topic, advice on raw materials that meet these standards or need a supply chain solution for your solvents, please visit: https://www.doeingalls.com/contact/. If you find the information in this blog helpful, consider subscribing: https://www.doeingalls.com/blog/ or following us on LinkedIn.