Regulatory Compliance

Begin with the end in mind

At Grace’s Fine Chemical Manufacturing Services (FCMS), in-house expertise in regulatory compliance complements expertise in our labs and manufacturing plants. Collaboration between regulatory and process experts guarantees that customers receive high-quality products. 

“The first thing we do from a regulatory standpoint is to understand the project and identify exactly how the end product is classified,” says Deron Neukomm, Quality Assurance Manager at Grace’s FCMS. For fine chemicals, that could be anything from a dietary supplement to an active pharmaceutical ingredient (API). “Then we work backwards from there to make sure that manufacturing complies with the right regulations,” Neukomm says.

Questions when considering manufacturing and compliance include, what current good manufacturing practices (cGMPs) have to be followed? At what point does a food ingredient become a dietary supplement? Where is the cGMP envelope around the chemistry of an API, and what is the regulatory starting material, the intermediate, and the API? Is a product in a clinical or a commercial phase?

The answers matter. The US Food and Drug Administration regulates dietary ingredients as food and dietary supplements under a separate standard; yet another standard is used for APIs. Regulatory requirements can differ according to whether a product is in the clinical phase of development or commercial manufacturing.

“Since some aspects of regulatory guidance are open to interpretation, we work with our customers’ regulatory and quality groups to make sure all stakeholders are on the same page,” says Melissa Janicki, Senior Regulatory Affairs Specialist at Grace’s FMCS.

An evolving compliance landscape

Evolution in the area of compliance has led to newer approaches to risk management and resulting quality, according to Neukomm. For example, more granular toxicology information has driven tighter regulations. “The letter C at the front of good manufacturing practices means ‘current’ for a good reason. There are more regulations, and specifications are tighter,” Neukomm says.  

Continuous improvement in manufacturing also contributes to advancements in regulatory compliance. Robust change control for process documentation ensures ongoing compliance, according to Janicki.

One way to keep regulatory compliance current is to consider quality in the early design stages of manufacturing processes. “It’s critical that chemists and engineers understand the impurities of concern for a particular product and then develop and implement a process to eliminate those impurities during production,” Neukomm says.

Risk-based process design helps scientists and engineers study every step of a process to identify hazards along the way. Such modeling allows the process development team to focus on steps with the greatest impact on regulatory compliance during production and ensure that the necessary control measures are in place.