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喜訊：寧波亞川注冊團隊新增一名國際審計官

廣大藥企的審計福音來啦！

中國藥企又，叒，叕被FDA貼出警告信啦！

日前，F(xiàn)DA官網(wǎng)掛出對浙江一藥企的警告信，F(xiàn)DA評論其對缺陷的回復(fù)“草率”并未對檢查期間發(fā)現(xiàn)的任何缺陷給予充分的糾正措施。

質(zhì)量體系如何合規(guī)？現(xiàn)場審計不會應(yīng)對，官方信不會回復(fù)，缺陷糾正不會開展！不用怕，寧波亞川來幫您！

廣大藥企的審計福音來啦！

我司專家團隊新增印度審計官之一：Sarang Athavale博士，100+家審計經(jīng)驗，100+場專業(yè)培訓(xùn)經(jīng)驗，31+年實驗室工廠工作經(jīng)驗，為您解決審計認證中的一切難題。

Dr. Sarang Athavale

Sarang Athavale 博士

Quality & GMP Auditor/質(zhì)量&GMP審計官

OVERVIEW

概 述

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

31年以上豐富工作經(jīng)驗，涵蓋質(zhì)量管理、質(zhì)量保障、質(zhì)量控制及無菌生產(chǎn)等方面。

• Successful experience of 100+ audits.

成功指導(dǎo)過100多家藥企通過審計。

• Successful experience of 100+ professional  trainings .

成功開展過 100多場專業(yè)培訓(xùn)會議

• Presently a Senior Quality Advisor to many pharmaceutical companies

目前身兼數(shù)家藥物公司高級質(zhì)量顧問

CORE STRENGTHS AND CORE COMPETENCE

關(guān)鍵優(yōu)勢及關(guān)鍵競爭力

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

根據(jù)國際標準設(shè)計藥廠質(zhì)量體系、協(xié)助完成體系建立并在過程中提供解決方案。

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

中英文工廠文件編制。

• GMP Audits of API , Intermediates and Formulation facilities.

原料藥、中間體及制劑工廠的GMP審計。

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

關(guān)于質(zhì)量體系、驗證與確認、GMP/GLP/ICH指導(dǎo)原則等方面的GMP專業(yè)培訓(xùn)

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

成功應(yīng)對許多國際審計，如USFDA/MHRA/EU GMP/MCC/ANVISA/GCC等。

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

無菌（注射劑）設(shè)備的特殊暴露處理

• Project documentation

項目文件

• Preparation for Pre FDA audits.

FDA預(yù)審計

• Develop software for QMS.

    開發(fā)QMS 軟件

EDUCATION

教 育

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

理科碩士 — 生物化學(xué)，Marathwada 大學(xué)，印度[1985]

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

商務(wù)管理碩士  Marathwada 大學(xué)，印度[1988]

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

理科碩士 —  質(zhì)量管理，Birla科技學(xué)院，印度[2001]

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

博士 — 質(zhì)量管理系統(tǒng)，Kingslake大學(xué)，美國[2014]

QUALITY SYSTEMS / GMP AUDITS

質(zhì)量系統(tǒng)/GMP審計

• 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.

    起草與執(zhí)行質(zhì)量手冊，涵蓋國際GMP指導(dǎo)原則與更新SOP文件。為原料藥和制劑公司（包括無菌生產(chǎn)）制定質(zhì)量保障與質(zhì)量控制功能，特別擅長處理變更控制系統(tǒng)，偏差處理，事件調(diào)查、批審核與批準，市場投訴處理、產(chǎn)品召回問題和進行cGMP培訓(xùn)。     

• 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.

   作為主負責(zé)人參與100家以上的審計并成功通過，涉及有USFDA, MHRA, MCC, TGA, AFSSAPS, ANVISA , GCC和 WHO認證。其中指導(dǎo)過美國、德國、西班牙和英國客戶的原料藥審計，合作過的國際公司有葛蘭素史克、賽諾菲、默克、雅培和輝瑞;中國客戶有壽光富康藥業(yè)有限公司、瑞陽藥業(yè)有限公司、杭州Singclean 藥業(yè)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.

    開展超過100場針對操作者，高管和高級經(jīng)理人關(guān)于質(zhì)量合規(guī)性的培訓(xùn)性會議。

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

    參與了在荷蘭開展的關(guān)于特殊藥物產(chǎn)品的無菌生產(chǎn)設(shè)備質(zhì)量要求培訓(xùn)

  Few of the API Companies audited are as follows :

    合作過的原料藥公司如下：

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 …