FDA重大重组对GMP检查有影响mMajor Reorganisation at FDA will affect GMP Inspec...

清歌一曲月如霜

美国食品和药物管理局已通知有关的重大重组。美国食品药物管理局已经宣布计划推出一个新的组织结构将于2015年1月生效。美国FDA将出台药品质量的新办公室（OPQ）。
据RAPS在线OPQ“已经得到最终批准从美国FDA推出，以及预期上市日期2015年1月1日，和领导的新名单”。“二零一四年十月十六日在一封电子邮件给CDER员工，伍德科克说，她将作为OPQ的第一代理主任，由副主任余锦基作为OPS代理主任的支持，他在2013年9月加入OPQ作为负责人取代韦伯的：
？项目办公室和监管操作（OPRO）：朱塞佩·兰达佐（署理）
？办公室政策对药品质量（OPPQ）：阿什利Boam（署理）
？办公生物技术产品（OBP）的：导演：史蒂夫·科兹洛夫斯基
？新药物产品办公室（ONDP）：萨拉·波普Miksinski（代理）
？生命周期药物产品办公室（OLDP）：苏珊Rosencrance（署理）
？测试与研究（OTR）办公室：露辛达（辛迪）Buhse（署理）
？流程的办公室和设施（OPF）：克里斯汀·摩尔（署理）
？监督办公室（OS）：特蕾莎穆林（代理）“
新的组织都会在FDA进行的所有检查产生重大影响。与该工序中，FDA希望改善其执行活动的效率。其它资料来源：FDA网页
就在数天前，医生玛格丽特汉堡，美国FDA专员宣布新计划校准。高级FDA官员组成的特别工作组“负责寻找和开发计划，以改变FDA的职能，流程和结构，以满足科技创新，全球化，日益广泛和复杂性，我们调整了产品所带来的挑战，新的法律部门。“其结果是，行动计划已公布：
？生物制品检定所2014年度计划校准行动计划
？制药公司2015年年度计划对齐行动计划
其中在程序中定义的许多不同的行动，美国食品药品管理局规定：
“CDER，CVM和ORA将合作提高一致性，建立对使用的监管工具，包括咨询和执法行动，提高效率，减少重复工作，并提供明确的问责明确的指导意见。一个专门机构，服药依从性的建立官员干部将有助于这一努力。此外，在2014年度，CDER，CVM和ORA将确定一个战略，明确任务和职责，包括领导角色和决策权，并简化和延迟器具有以下达标活动有关的业务流程：
- 国内和国外的警告信;
-Judicial执法行动;
- 进口的决定;
- 复合;
- FDASIA，以及其他合规管理工具;
- 临床取消资格;和
- 召回“
世界各地不同的机构需要应对的全球性制药环境的新挑战。制造业务已转移到世界各地 - 尤其是亚洲。质量水平从未如此多样。假冒和欺诈是一个令人关注的问题。但也是主要的GMP符合性偏差都惊动了世界各地的监管机构。更全面的执法迫切需要和产品质量是现在人们关注的焦点。



The US Food and Drug Administration has informed about a major reorganisation. The FDA has announced plans to introduce a new organisational structure which will become effective on January 2015. In the center of the reorganisation, the FDA will introduce the new Office of Pharmaceutical Quality (OPQ).
According to RAPS online OPQ "has gotten final approval to launch from FDA, along with an expected launch date—1 January 2015—and a slate of leaders for the new "super office." In an email to CDER employees on 16 October 2014, Woodcock said she would serve as the first acting director of OPQ, with support from Deputy Director Lawrence Yu, who replaced Webber as acting director of OPS in September 2013. Also joining OPQ will be a large slate of other leaders:
?Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
?Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
?Office of Biotechnology Products (OBP): Director: Steve Kozlowski
?Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
?Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
?Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
?Office of Process and Facilities (OPF): Christine Moore (Acting)
?Office of Surveillance (OS): Theresa Mullin (Acting)"
The new organisation will have a major impact on all inspections performed by FDA. With this step, FDA wants to improve the efficiency of its enforcement activities. Other Sources: FDA Webpage
Just a few days earlier, Dr Margaret Hamburg, Commissioner of the US FDA announced the new Program Alignment. A task force of senior FDA officials was "charged with identifying and developing plans to modify FDA’s functions, processes, and structure in order to meet the challenges posed by scientific innovation, globalization, the increasing breadth and complexity of the products that we regulate, and new legal authorities." As a result, action plans have been published:
?Biological Products FY2015 Program Alignment Action Plan
?Pharmaceuticals FY 2015 Program Alignment Action Plan
Among the many different actions defined in the programme, the FDA states:
"CDER, CVM and ORA will collaborate to improve consistency and establish clear guidance about the use of regulatory tools, including advisory and enforcement actions, to increase efficiency, reduce duplication of efforts, and provide clear accountability. The establishment of a specialized Agency drug compliance officer cadre will contribute to this effort. Additionally, in FY2015, CDER, CVM and ORA will identify a strategy to clarify roles and responsibilities, including lead roles and decision rights, and streamline and delayer the business processes associated with the following compliance activities:
- Domestic and foreign Warning Letters;
-Judicial Enforcement Actions;
- Import Decisions;
- Compounding;
- FDASIA, and other administrative compliance tools;
- Clinical disqualifications; and
- Recalls"
Worldwide the different agencies need to react to the new challenges of a global pharmaceutical environment. Manufacturing operations have been moved to different parts of the world - especially to Asia. The quality level has never been so diverse. Counterfeit and fraud are an issue of concern. But also major GMP compliance deviations have alarmed regulators worldwide. A more comprehensive enforcement is urgently needed and product quality is now in the center of attention.

Master

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怀谷

学习！

林听

更全面的执法迫切需要和产品质量是现在人们关注的焦点。说得好

一沙一叶

给你简单调整一下英语。

愚公想改行

余锦基博士曾在多次培训中谈到了这个变化。