EU may add environmental regs to GMPs

European authorities are considering legislation that would augment Good Manufacturing Practices with environmental controls. The effort is aimed at curbing unhealthy emissions from pharma manufacturing plants in developing countries, notably India.

Swedish researchers have reported emissions in India at a level that can "seriously impact" the health of humans and animals, according to Pharmabiz.

EU authorities, citing the well-developed inspection system for GMPs, reason that adding environmental parameters to the GMP framework will ensure environmental compliance. The legislative effort stems from a report that quantified the concentrations of medicinal products in wastewater from a plant following purification. That purification plant is outside Hyderabad. Much of the volume of drug substances produced in the region is exported to Europe and the U.S.

Lawmakers say they plan to create a separate legal document defining emission level limits for certain substances. A reference to the document will be inserted into the requirement to comply with GMP in production.

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