GMP Audit Procedures This SOP describes the process of planning, performing, reporting on, and following up on various audits of your systems, such as Internal Quality audits. Example of Checklist for Batch Documentation This SOP describes identifying all documentation relevant to a production process...
The GMP Certification Audit Checklist covers the seven main areas of the GMP Standard: Context of the organization Leadership Planning Support Operation Performance evaluation Improvement Certvalue – YOUR GMP CERTIFICATION CONSULTANT Certvalueis a reputable and widely recognized global leader in the provisi...
The laboratory informatics solution should have validated electronic audit trails that record information about each transaction, both for initial entries as well as modifications to entries. 6.4.3数据采集-应在实验室信息学解决方案中采集分析结果。在数据模型设计过程中,应仔细评价并定义结果数据中包含的支持...
to test finished drug product (b)(4) spray. Because this instrument lacks back-up and audit ...
Head). The responsibility of these auditors is to conduct an independent reliability audit in order...