Medicinal Products and Quality Assurance

Medicinal finished products are intended for administration to patients for the treatment amelioration of disease (similarly for veterinary finished products and the treatment of animals). For smaller companies, particularly those companies using contract manufacturing, it is important to assess and monitor the quality systems at the contract site.

In addition it may be necessary to transfer manufacture of a product from one facility to another, e.g., during the transfer from clinical trials manufacture to commercial manufacture. Site transfer requires attention to detail to ensure that the necessary documentation and records are created and maintained and the final project reports prepared and authorized. For such projects it is advisable for the contractee to have access to the necessary understanding and expertise.

FinnBrit Consulting can assist in both the assessment of routine manufacturing and in technical transfer and validation.

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