合同实验室

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The questions listed in Figure 17.B-1 should be addressed when carrying out a suitability test for an external testing laboratory. The professional competence of the laboratory can be assessed by third party certification of the contract lab, e.g. manufacturing license, GMP-certification and accreditation, by inspection reports of other pharmaceutical companies or by its level of active participation in committees and organizations as well as scientific contributions made and involvement in projects where an expert opinion was given.
Figure 17.B-1 Criteria for the selection of an external laboratory
Mandatory suitability criteria
        Is the laboratory notified to the national authorities for testing of medicinal products?
        Is the laboratory inspected regularly by a competent authority and found acceptable e.g. by local authorities or by the FDA?
        Is a manufacturing license or a GMP-certificate issued by a competent authority?
        Has the laboratory been accredited in accordance with ISO/IEC 17025?
        Are suitable rooms and facilities available for contract analysis?
        Are GMP standards observed during work at the laboratory?
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