Confused About the Global Requirements for Nitrosamines?
We will Help You Navigate This Unchartered Territory!

Nitrosamines are a well characterized family of carcinogens that has been identified in thousands of consumer products recently, including small molecule pharmaceuticals and other finished goods. They are produced by the chemical reactions of a nitrosating agent with structural elements in a compound (secondary or tertiary amines) nitrosamines are formed through side reactions during the manufacturing process and can even occur after the product has been produced and sitting in storage. Though the carcinogenic nature of nitrosamines has been known for half a century, the issue has recently taken center stage in the pharmaceutical world as traces of these compounds have been discovered in several commonly prescribed drug classes, including angiotensin receptor blockers (ARBs).

Following the recall of certain drugs considering the disturbing discovery of these compounds in commonly administered drug products, the FDA took a series of forward-looking measures to address the concern. In February 2021, the Agency released updated guidance that details steps that pharmaceutical manufacturers should take to detect and prevent unacceptable levels of theses carcinogen in products as defined by the FDA and other regulatory counterparts around the globe. Per the guidance, pharmaceutical companies are now required to implement a comprehensive risk assessment strategy to detect and prevent unacceptable levels of nitrosamine impurities in all chemically synthesized active pharmaceutical ingredients and approved or marketed drug products that contain those active pharmaceutical ingredients—followed by confirmatory testing if unacceptable risks are identified.

While the entire process has become a source of frustration for pharmaceutical manufacturers, the initial risk assessment in and of itself has proven time-consuming and highly involved, eating up resources that should be focused on other strategic priorities in an organization. It is incumbent on the pharma company to develop the analytical methods to detect and quantify impurities and complete the assessment. For those that lack the targeted expertise and dedicated resources to meet this labor-intensive requirement, the process can be a daunting undertaking, wrought with headaches and uncertainty.

Backed by a team of experts with deep FDA and industry experience, Lachman Consultant Services, Inc. can help you apply the appropriate analytical techniques to determine the risk of nitrosamines in your products. With vast risk assessment expertise, including work with Fortune 500 companies on thousands of SKUs, our highly accomplished consultants have a long history of assessing risk and making actionable recommendations that are scientifically and technically accurate. Though this may not be your area of expertise, it is ours and we can help remove this burden.

For more information about how Lachman Consultant Services, Inc. can help you address the complex FDA guidelines and reduce the risk of these unwelcome carcinogenic guests in your products, contact us here.