Good Distribution Practices ( Gmp )

2099 WordsApr 17, 20169 Pages
Good Distribution Practices Introduction The manufacture of medicinal products is subject to guidelines referred to as Good Manufacturing Practices (GMP). These help to ensure the quality, potency and identity of the product throughout all stages of manufacture to maximize the safety and therapeutic value to the patient. However to reach the consumer, the product must be distributed. Distribution includes the supply, export and holding of medicinal products in an ever more intricate web of relationships. Therefore it is appropriate that in order to maintain the level of assurance attained in GMP; the distribution network must also have its own guidelines known as Good Distribution Practices (GDP). The legislative impetuous for GDP arrived from European Directive (2001/83/EC) which was in turn brought into Irish legislation through The Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 538 of 2007). The legislation refers to ‘wholesale’ distributors as those involved in all activities related to distributing medicinal products aside from supplying directly to members of the public. The GDP was outlined at the European level in Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) and updated in (2013/C 343/01). In turn, additional clarifications from an Irish perspective were published by the Health Products Regulatory Authority (HPRA) in their own Good Distribution Practice of Medicinal
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