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喜讯:宁波亚川注册团队新增一名国际审计官 广大药企的审计福音来啦!

喜讯:宁波亚川注册团队新增一名国际审计官

广大药企的审计福音来啦!

中国药企又,叒,叕被FDA贴出警告信啦!

日前,FDA官网挂出对浙江一药企的警告信,FDA评论其对缺陷的回复“草率”并未对检查期间发现的任何缺陷给予充分的纠正措施。

质量体系如何合规?现场审计不会应对,官方信不会回复,缺陷纠正不会开展!不用怕,宁波亚川来帮您!

广大药企的审计福音来啦!

我司专家团队新增印度审计官之一:Sarang Athavale博士,100+家审计经验,100+场专业培训经验,31+年实验室工厂工作经验,为您解决审计认证中的一切难题。

 

Dr. Sarang Athavale

Sarang Athavale 博士

Quality & GMP Auditor/质量&GMP审计官

OVERVIEW

  • Experience of 31 + years in various capacities in Quality Management, Quality Assurance, Quality Control & Sterile Manufacturing.

31年以上丰富工作经验,涵盖质量管理、质量保障、质量控制及无菌生产等方面。

  • Successful experience of 100+ audits.

成功指导过100多家药企通过审计。

  • Successful experience of 100+ professional  trainings .

成功开展过 100多场专业培训会议

  • Presently a Senior Quality Advisor to many pharmaceutical companies

目前身兼数家药物公司高级质量顾问

 

CORE STRENGTHS AND CORE COMPETENCE

关键优势及关键竞争力

  • Design and implementation of Quality Systems of international standards in pharma companies.

根据国际标准设计药厂质量体系、协助完成体系建立并在过程中提供解决方案。

  • Documentation of complete factory in dual language(Chinese & English).

中英文工厂文件编制。

  • GMP Audits of API , Intermediates and Formulation facilities.

原料药、中间体及制剂工厂的GMP审计。

  • GMP training in Quality Systems, Validation and Qualification, General GMP, GLP, ICH guidelines.

关于质量体系、验证与确认、GMP/GLP/ICH指导原则等方面的GMP专业培训

  • Successfully faced several regulated market audits – USFDA, MHRA, EU GMP , MCC,  ANVISA , GCC & others.

成功应对许多国际审计,如USFDA/MHRA/EU GMP/MCC/ANVISA/GCC等。

  • Special exposure in handling of Sterile ( Injectables ) facilities.

无菌(注射剂)设备的特殊暴露处理

  • Project documentation

项目文件

  • Preparation for Pre FDA audits.

FDA预审计

  • Develop software for QMS.

    开发QMS 软件

EDUCATION

Master of Science – Biochemistry, Marathwada University, India [1985]

理科硕士 — 生物化学,Marathwada 大学,印度[1985]

Master of Business Administration, Marathwada University, India [1988]

商务管理硕士  Marathwada 大学,印度[1988]

Master of Science - Quality Management, Birla Institute of Technology and Science, India [2001]

理科硕士 —  质量管理,Birla科技学院,印度[2001]

Ph.D. - Quality Management Systems , Kingslake University, USA [2014]

博士 — 质量管理系统,Kingslake大学,美国[2014]

QUALITY SYSTEMS / GMP AUDITS

质量系统/GMP审计

  • Preparation and implementation of Quality Manual encompassing international GMP guidelines and updating SOP documentation.Established Quality Assurance and Quality Control functions at API and Formulations including sterile manufacturing.Specially expert in Change Control System , Deviations handling , Investigations of incidents , Batch Review and Approval, Market complaints handling, Product recalls and Training to all for cGMP.

    起草与执行质量手册,涵盖国际GMP指导原则与更新SOP文件。为原料药和制剂公司(包括无菌生产)制定质量保障与质量控制功能,特别擅长处理变更控制系统,偏差处理,事件调查、批审核与批准,市场投诉处理、产品召回问题和进行cGMP培训。     

  • Faced more than 100 audits as Lead In-charge of  USFDA, MHRA, MCC, TGA, AFSSAPS, ANVISA , GCC, and WHO Geneva certification. All were successfully granted without critical observations.Conducted API audits for clients from USA , Germany , Spain and UK. International clients are GSK, Sanofi, Merck , Abbott & Pfizer.Chinese clients are Shouguang Fukang Pharma Co. Ltd, Reyoung pharmaceuticals, Singclean Medical Products Co. Ltd.

   作为主负责人参与100家以上的审计并成功通过,涉及有USFDA, MHRA, MCC, TGA, AFSSAPS, ANVISA , GCC和 WHO认证。其中指导过美国、德国、西班牙和英国客户的原料药审计,合作过的国际公司有葛兰素史克、赛诺菲、默克、雅培和辉瑞;中国客户有寿光富康药业有限公司、瑞阳药业有限公司、杭州Singclean 药业有限公司。

  • Conducted more than 100 training sessions for Operators , Executives & Senior Managers on Quality Culture of Compliance as per GMP norms with Ranbaxy and many more Companies.

    开展超过100场针对操作者,高管和高级经理人关于质量合规性的培训性会议。

  • Undergone ‘Know How’ training for medical grade PVC in Solvay Draka ,NETHERLAND for quality requirements for a sterile manufacturing facility of specialized drug products.

    参与了在荷兰开展的关于特殊药物产品的无菌生产设备质量要求培训

  Few of the API Companies audited are as follows :

    合作过的原料药公司如下:

Granules India Ltd. , Dr. Reddy’s Labs Ltd., Cadila Pharmaceuticals Ltd., Neuland Labs Ltd., IPCA Labs Ltd., Amoli Organics Ltd. , Parabolic Drugs Ltd., Natco Ltd. , Synthochem Labs Ltd., Sami Labs Ltd., Geetanjali Chemicals Pvt. Ltd., Hetero Drus Ltd., Pearls Organics Ltd. , Wockhardt Ltd., Atul Industries , Supriya Life Sciences Ltd., Matrix Labs Ltd. , SMS Pharma ( Oncology ) , Sharp Mint Ltd. and many more …

 

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