Regulatory requirements for chemicals in the pharmaceuticals industry

Ensuring compliance in research and manufacturing is fundamental across all industries, especially where controlled and regulated chemicals are concerned.

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Any industry that uses large amounts of chemicals must be able to identify and handle both controlled and regulated substances appropriately.

Today’s chemical and pharmaceutical industries are faced with an increasing number of regulatory requirements pertaining to the safe and legal storage, supply, and usage of chemicals.

For most, the legislations that first springs to mind typically relate to COSSH, MSDS, and possibly REACH when correctly using chemicals in bulk. However, for chemicals and regulatory managers, such legislation only corresponds to a small subset of the regulations which should be taken into account.

Detailed and complex regulations relating to controlled drugs, chemical weapons, and the precursor chemicals that can be used to make them are extremely important, ozone-depleting, military and dual-use chemicals, and the PIC/Rotterdam convention also may need to be taken into consideration. A large number of common chemicals and intermediates fall under the remit of these laws. It is often these regulations which are more applicable to R&D and manufactering in the pharmaceuticals industry.

The greatest obstacle to ensuring compliance is to first establish exactly what regulated or controlled chemicals you have. For more extensive chemical libraries, particularly those with proprietary or novel chemicals attempting to match keywords or names is much more complicated and often will not work.

Moreover, today’s legislation is no longer concerned with regulating a single substance. Instead, millions of chemicals may be covered by “generic statements” or "chemical family controls" to control areas of chemical space that possess similar properties.

Using keywords and name-searching approaches when dealing with generic statements is not feasible as the majority of chemicals they control are not named and may not even exist yet.

Scitegrity has published a white paper discussing some of these challenges and key, simple steps that can be followed to improve compliance, identify regulated chemicals and make compliance more robust. To find out more and read the white paper, please click here.

About Scitegrity

Want to know if your chemical is controlled, regulated, has the potential for abuse or just need a tariff code?

Our regulatory and chemistry experts encode chemical regulations from around the world allowing you to simply answer these questions and more by drawing or looking up a chemical structure.

We make regulatory compliance a simple, robust, background process. Join with 5 of the worlds top 10 pharma, chemical suppliers, regulators, CROs, forensics labs and more who trust and rely on our solutions.

Scitegrity was founded in 2011 by ex-Pfizer, GSK and Roche chemists and data scientists with the goal of making compliance to chemical regulations are far more robust, accurate and automatic.

By automatically checking all the chemicals an organisation has at the structure level, it allows enterprise wide automatic compliance checks against hundreds of regulations globally, even for novel and proprietary chemical collection running into millions of chemicals.

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Last updated: Mar 20, 2023 at 9:54 AM


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