Steroid manufacturing gmp

The topic of dedicated facilities continues to be the subject of a significant amount of debate but the GMP/GDP Inspectors Working Group has agreed that the use of dedicated facilities should normally be required when beta-lactam antibiotics are produced. In addition dedicated facilities should be used when live pathogenic organisms are handled. Further guidance on the use of dedicated facilities for certain product categories may also be found in the GMP Annexes (. veterinary products in Annex 4, biologicals in the new draft of Annex 2, which should be available for further public comment in the first quarter of 2010). In the meantime, for other products, manufacturers introducing a product into shared facilities should carry out an assessment of all relevant product and process characteristics to evaluate whether it is suitable for production in shared facilities. This assessment should include input from a toxicologist . Where the product has known sensitizing potential, or is highly potent or toxic, the Supervisory Authority should be consulted to discuss the manufacturer’s risk management measures.

Steroid manufacturing gmp

steroid manufacturing gmp

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