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Question: ArrayWhat are the training programs for inspectors? (GCP No. 57 of 2020, Article 52 (2)) @ @ The inspection standards refer to the new version of GCP, and inspectors need to learn the new version of GCP. The implementation of the new GCP will improve the overall quality of inspections, ensuring their independence and compliance. Inspectors need to have corresponding qualifications, experience, and training, and should have written records. This requirement should be specified in the company's SOP. You can refer to the SQA Global Guidelines for GCP Audit.
Answer:

稽查标准参照新版GCP,稽查员需要学习新版GCP。新版GCP的实施会提高整体稽查的质量,保证稽查的独立性和合规性。

稽查员需要有相应的资质、经验以及培训,应有书面记录。该要求应该在公司SOP中做具体规定。

可参考SQA Global Guideline for GCP Audit