More on MPA’s report on GMP and environmental issues

Last Thursday (June 16, 2011) the report from Swedish MPA on the possibility of introducing environmental requirements into GMP (Good Manufacturing Practice) was issued. See my blog post from June 16 where I give a few comments to the report. In the blog post I quoted the four proposed action points, although they were only accessible in Swedish. I have now identified an English translation and publish it here to help the foreign readers:

1. Changes in pharmaceutical directives
Among pharmaceutical directives, insert an obligation for manufacturers of pharmaceuticals to comply with the requirements of a special new legal document, a new EU regulation (see item 2 below), in which emission levels for certain compounds are stated. The new obligation among pharmaceutical directives should be inserted in the requirement to comply with GMP in production.

2. Introduction of a new EU regulation
A new EU regulation should be created. The point of departure in proposing a new legal document is that it should stipulate the pharmaceutical compounds that need to be controlled in terms of emissions from production as well as the emission levels that are not permissible. Cosmetics legislation in the EU might serve as a model for structuring this document.  

3. Proposed compounds for priority attention
What should receive top priority for a first step in the above-mentioned EU regulation are those pharmaceutical compounds for which there is scientific evidence that the external environment, and thereby public health, is negatively impacted. First and foremost this concerns antibiotics, certain pharmaceuticals with hormone-disrupting compounds, and substances that can constitute a risk to the environment in that they are used and produced in large volumes.

4. Work to identify further candidates
The new EU regulation should establish a procedure for how further compounds are to be identified and how concentration limits are to be determined. These tasks will need to be addressed by some EU body that has the relevant environmental expertise.


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