Question of the Day

What is a product specification file ?

Investigational medicinal products may only be shipped by order of the sponsor and according to instructions
According to Annex 13 a product specification file is a re­ference file containing, or referring to files containing, all the information necessary to draft the detailed written instructions on processing, packaging, quality control testing, batch release and shipping of an investigational medicinal product.
[GMP Manual, Chapter C.6.13]


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