目的 本《标准操作政策和程序》Standard Operating Policy and Procedure(SOPP)(SOPP)是生物制品评价和研究中心(CBER)工作人员安排和举行 CBER 人员与受监管行业代表(包括相关产品的申办者/申请人)和/或申办方-研究人员(sponsor-investigators)...
本《标准操作政策和程序》Standard Operating Policy and Procedure(SOPP)(SOPP)是生物制品评价和研究中心(CBER)工作人员安排和举行 CBER 人员与受监管行业代表(包括相关产品的申办者/申请人)和/或申办方-研究人员(sponsor-investigators)之间监管会议的指南,以解决与药品开发有关的问题。 2 范围 1.本 SOPP适用于研究...
5、Understanding of instrument compliance 5.1►Standard Operating Procedures 标准操作程序 (SOP’s) 所有仪器均具有标准操作程序(SOP)? 这些SOPs是否为最新版本? 这些SOPs是否经过批准且受控? 是否有管理色谱积分的 SOP? Do all instruments have a Standard Operating Procedure (SOP) Are the SOP’s up to ...
During our 2015 inspection, FDA raised concerns regarding your practice of trial injections. The inspection found that your procedures permitted “Trial injection(s) of sample solutions.” Our current inspection found your (b)(4) standard operating procedure (SOP) had not been revised to remove th...
In response to this letter, provide your standard operating procedure (SOP) describing your firm’s ongoing stability program. Also, provide stability data demonstrating that each OTC drug product distributed by your firm to the United States meets all specifications throughout its expiry. ...
In your response, you stated that operators had been re-trained on line-clearance and a timelier cleaning schedule for the production area was developed. However, the standard operating procedure (SOP) for line clearance was not provided and your SOP for Prod...
4. Responsibilities/Contacts 5. Agency-Wide Procedures 6. Effective Date 7. History 1. PURPOSE The purpose of this Standard Operating Procedure (SOP) is to provide a general procedure for determining FDA’s regulatory response when a cargo theft involving an FDA-regulated product has ...
• A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program. •结果摘要:对所有组分进行检验,以评估每个组分生产商的COA可靠性。包括描述...
In your response, it was stated the root cause of releasing drug product prior to completion of all quality control testing was “due to the belief that such could be proceeded to next step with customer’s approval.” Additionally, you modified your standard operating procedure regarding the pr...
SOP:Standard Operating Procedure标准操作规程 CRF:Case Report form病例报告表 DLT:剂量限制毒性 MTD:最大耐受剂量 KPS:Karnofsky Performance Status行为状态评分 CR:complete response完全缓解 PR:partial response部分缓解 SD:病情稳定 PD:progressive disease病情进展 CTC:常用药物毒性标准 IEC:independent ethics committe...