19 settembre 2014

Revisione del cap. 3, Premises and Equipment, delle GMP

In data 13 agosto 2014 è stata pubblicata una revisione del capitolo 3 delle GMP relativo ai locali e alle attrezzature delle aziende farmaceutiche.
La revisione ha toccato solo un puntoi del testo di cui riporto il confronto:

Versione in vigore 
Versione in vigore dal prossimo 01/03/2015
In order to minimise the risk of a serious medical hazard due to cross-contamination, dedicated and self contained facilities must be available for the production of particular medicinal products, such as highly sensitising materials (e.g. penicillins) or biological preparations (e.g. from live micro-organisms). The production of certain additional products, such as certain antibiotics, certain hormones, certain cytotoxics, certain highly active drugs and non-medicinal products should not be conducted in the same facilities.  For those products, in exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validations are made. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of medicinal products.Cross- contamination should be prevented for all products by appropriate design and operation of manufacturing facilities. The measures to prevent cross-contamination should be commensurate with the risks. Quality Risk Management principles should be used to assess and control the risks.
Depending of the level of risk, it may be necessary to dedicate premises and equipment for manufacturing and/or packaging operations to control the risk presented by some medicinal products.

Dedicated facilities are required for manufacturing when a medicinal product presents a risk because:
  • the risk cannob be adequately controlled by operational and/or technical measures
  • scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly sensitising materals such as beta lactams) or
  • relevant residue limits, derived from the toxicological evaluation, cannot be satisfatorily determined by a validated analytical method

Questo documento entrerà in vigore a marzo 2015.

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