The risks associated with handling highly pharmacologically active products can cause concern in the industry; however experts in toxicology, industrial hygiene, chemistry, safety and quality assurance agree that a risk-based approach to safety is most appropriate, Piramal Pharma Solutions elaborates
There are no regulations or guidelines that prescribe a mandated approach or require segregation of products based on pharmacological activity. There is, however, a lot of interpretation and misunderstanding across the industry.
There is no requirement to use dedicated facilities or even dedicated equipment. The prevailing opinion is to control by risk mitigation on a case-by-case basis.
The current risk-based approach to safety relies on two basic concepts:
Read more about this topic by downloading the full whitepaper on the safe handling of highly active compounds from Piramal Pharma Solutions.