US-based environmental consultants Gradient advises pharmaceutical firms on requirements needed to comply with the European Medicines Agency's (EMEA's) new environmental assessment guidelines, which came into force on 1 January 2007.
There is a concern that bioactive compounds released into the environment may have a damaging effect on the environment, animals and humans. Sewage is known to contain varying levels of pharmaceuticals but the effectiveness of wastewater treatment varies.
Scientists around the world often find drugs in water samples taken from streams and other waterways, but little is known about the environmental effects of the substances or indeed by-products created during chlorine treatment.
Businesses that fully understand and comply with these regulatory guidelines will be at a competitive advantage, ultimately resulting in potential cost and resource savings to the company, according to Gradient.
"Some parts of the guideline recommendations could be used as a "cookbook" for preparing environmental assessments, but doing so would often lead to an ineffective use of resources. We help clients take a sound science approach to addressing the environmental concerns raised in the EMEA guidelines without following the generic assessment recommendations when they do not make sense," Greg Ehrlich, Gradient client services director, told In-PharmaTecnologist.com.
The consulting service Gradient has focussed on their client's goals, internal expertise and data availability to offer a custom-designed data collection programme for clients to use in their compliance testing and development process.
The EMEA's new guidelines have been prepared to guide market-authorisation applicants through requirements in terms of safety, quality and efficacy of medicines, supported with tests to evaluate the environmental behaviour and toxicity of active pharmaceutical ingredients (APIs) in their products from the 1 January 2007.
These new guidelines show that companies can use a higher flexibility over test and assessment approaches, where EMEA previously required generic testing and assessment procedures. Other changes include the need for APIs to be categorised according to PBT (persistent, bioaccumulative and toxic). EMEA also advises on long-term chronic tests for API presence in water.
Gradient has prepared a free of charge bulletin - Sound Strategies for Complying with the Final EMEA Pharmaceutical Environmental assessment Guidelines -"that highlights the key changes from the last draft to the final guidelines and indicate some high level strategies for cost effective compliance". The bulletin is available in mid to late January.
The consultant firm Gradient employs 75 staff and has over twenty years of experience within compliance with global regulations and guidelines. The length of compliance training varies depending on a company's specific needs and goals but is in general between half a day to two days.