EU

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The European environment state and outlook report (SOER)  2015  delivers a comprehensive assessment of the European environment’s state, trends and prospects, in a global context. It highlights a number of factors of concerns in relation to the pharmaceutical industry in it’s 20 year plus outlook citing:

Emerging pollutants, such as from pharmaceuticals and personal care products, may be a future concern, as may be algal blooms and pathogenic microorganisms.

Chemicals from pharmaceuticals, personal care products, and other consumer products can have adverse effects on the environment and on human health. Endocrine disruption, which impacts the body’s hormonal system, is of particular concern. Unfortunately, the environmental pathways and potential human health impacts of these chemicals are poorly understood, especially when people are exposed to mixtures of chemicals, or when exposure occurs in vulnerable population groups such as pregnant women, small children and people suffering from certain diseases (EEA, 2011d; Larsson et al., 2007; EEA, 2012f; EEA/JRC, 2013). Reducing chemical pollution at source has become an important resource efficiency measure, as advanced wastewater treatment and treatment of drinking water is energy and chemicals intensive.

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A qualified person (QP) is a technical term used in European Union pharmaceutical regulation (and therefore Ireland). The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements. (EudraLex, Volume 4, Chapter 1). In the USA there is no specific requirement from the FDA for a person specifically called a “qualified person” but the FDA requires that a company selects someone who is qualified to be the person who signs off on batches.

The Orange Guide: Rules and Guidance for Pharmaceutical Manufacturers and Distributors (familiarly known as the Orange Guide) is an essential reference work for all those involved in the manufacture or distribution of medicines in or for Europe. It is compiled by the UK drug regulatory body, the MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It therefore contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation.

 

The Orange guide is not available for free access but a sample chapter on premises and equipment can be found here. A full list of its index is also available here.

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book)  is a list that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).

Did you know that when the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, “It’s almost Halloween. How about orange?” Before long, The Orange Book had become a popular short title for this important publication. Courtesy FDA

The downloadable Orange Book “list” can be found here:

http://www.fda.gov/drugs/informationondrugs/ucm129689.htm