HAPIs Sample Clauses

HAPIs. 15.1 Euticals shall not conduct production and handling of highly sensitizing materials (such as penicillins or cephalosporins) in the equipment being used for the SUBSTANCE(s). Production of such materials in the same building being used for the SUBSTANCE(s) is permitted only if performed in a closed and dedicated system. 15.2 In case of highly active or toxic materials, such as potent hormones, cytotoxic compounds, or other potentially hazardous materials manufactured by Euticals in the same facilities as used for SUBSTANCE(s), validated inactivation and/or cleaning procedures should be in place.
Sample 1
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HAPIs. 15.1 CONTRACT ACCEPTOR shall ensure that its facilities are used in line with any authorizations for HAPIs granted by the competent regulatory authority. 15.2 CONTRACT ACCEPTOR shall not conduct production and handling of highly sensitizing materials (such as penicillins or cephalosporins) in the equipment being used for the SUBSTANCE(s). Production of such materials in the same building being used for the SUBSTANCE(s) is permitted only if performed in a closed and dedicated system. 15.3 CONTRACT ACCEPTOR shall not conduct the production of certain additional products, such as certain highly active or toxic drugs and non-medicinal products in the same equipment used for the SUBSTANCE(s). 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 validated inactivation and/or cleaning procedures are in place.
Sample 1
HAPIs. HOVIONE shall not conduct production and handling of highly sensitizing materials (such as penicillins, cytotoxics or cephalosporins) in the equipment being used for the manufacturing of Product. Manufacturing of such materials in the same building being used for the Product is permitted only if performed in a closed and dedicated system. For any other type of materials manufactured by HOVIONE in the same facilities as used for Product, validated inactivation and/or cleaning procedures and appropriate containment shall be in place.
Sample 1

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