전문 번역가, 번역 회사, 웹 페이지 및 자유롭게 사용할 수 있는 번역 저장소 등을 활용합니다.
article xii inspections des bpf 1.
article xii gmp inspections 1.
마지막 업데이트: 2015-05-14
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a) les inspections sont habituellement destinées à déterminer le respect des bpf par le fabricant.
(a) inspections shall routinely assess the compliance of the manufacturer with gmp.
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• autres mesures visant à encourager le respect spontané des bpf par l'entreprise 8.
• other measures to promote voluntary compliance by firm 8.
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2.1.1 attestation de respect constant des bpf, y compris le contrôle et la validation du traitement;
2.1.1 evidence of ongoing gmp compliance including process control and validation;
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2.1.1 une preuve du respect continu des bpf, notamment du contrôle et de la validation du traitement;
2.1.1 evidence of ongoing gmp compliance including process control and validation;
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ce certificat ne couvre pas toutes les exigences des bpf.
this does not cover all gmp requirements.
마지막 업데이트: 2015-05-14
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annexe 6 des bpf du pic/s fabrication des gaz médicaux
annex 6 to the pic/s gmp guide manufacture of medicinal gases
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inspections obligatoires avant la commercialisation contre le règlement des bpf.
mandatory pre-market inspections against gmp regulations.
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françois chevalierspécialiste des bpf, ocpc, bcal* ottawa (ont.)
yolande larose biologist-reviewer, bbr*** ottawa, ont.
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ce terme n'est toutefois pas défini dans le glossaire des bpf.
however, this term is not defined in the glossary of the gmps.
마지막 업데이트: 2015-05-14
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annexe 3 exigences obligatoires des bpf liste des dispositions lÉgislatives applicables :
appendix 3 mandatory gmp requirements list of applicable legislative provisions.
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• absence de connaissances des bpf ou de formation à celles-ci;
• no gmp knowledge or training
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article xi demandes de rapports d’inspection des bpf et transmission des rapports 1.
article xi requests for and transmission of gmp inspection reports 1.
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ils ont également suivi les réunions ad hoc des services d'inspection des bpf en 2002.
this was particularly important in light of the planned changes in the working practices of the scientific committees.
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경고: 이 정렬은 잘못되었을 수 있습니다.
잘못된 경우 삭제해 주십시오.
inspection/évaluation des bpf la composante inspection/évaluation des bpf dépend des opérations.
gmp inspection/assessment the gmp inspection/assessment fee component is operation specific.
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c.2.3.2 fournir une description détaillée de la formation relative aux exigences des bpf.
c.2.3.2 give details of training relative to gmp requirements.
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6.2.5 ce document porte uniquement sur les aspects dont les inspecteurs des bpf doivent tenir compte.
6.2.5 this document only addresses the aspects that the gmp inspectors will consider.
마지막 업데이트: 2015-05-14
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france dansereau, co-présidente chef, unité des bpf, ocpc, bcalottawa (ont.)
stephane taillefercompliance officer, office of compliance, planning and coordination, bce longueuil, que.
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le certificat des bpf pour le produit pharmaceutique visé (soit l'original ou une copie notariée) 5.
gmp certificate for the given pharmaceutical (either original or notarized copy) 5.
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annexe 2 à l’édition actuelle des bpf : fabrications des médicaments utilisés dans les essais cliniques / avril 2004
every fabricator, packager/labeller and tester shall maintain on their premises in canada details of the personnel employed to supervise the fabrication, packaging/labelling and testing, including each person's title, responsibilities, qualifications, experience and training.
마지막 업데이트: 2015-05-14
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