It is important to distinguish a drug with a characteristic that poses a high occupational risk from its characteristic therapeutic effect & benefit, in short potency.
For example, a drug that increases the acceptance of a transplated organ is given to patients in high doses. However, occupational exposure of that same drug may cause birth defects in the off-spring of workers who may come into contact with it. Therefore OEL (Occupation Exposure Levels) will play a major role rather than plain potency of the api.
If one is able to establish effectiveness of manufacturing environment containment systems, waste stream management and industrial hygiene (IH) practises performed with respect to OEL, further complemented by cleaning validation data, should by far indicate compliance.
For example, a drug that increases the acceptance of a transplated organ is given to patients in high doses. However, occupational exposure of that same drug may cause birth defects in the off-spring of workers who may come into contact with it. Therefore OEL (Occupation Exposure Levels) will play a major role rather than plain potency of the api.
If one is able to establish effectiveness of manufacturing environment containment systems, waste stream management and industrial hygiene (IH) practises performed with respect to OEL, further complemented by cleaning validation data, should by far indicate compliance.
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