Pharmaceutical Manufacturing Deviation and Failure Investigations: Principles, Practices, and Case Studies
暫譯: 製藥製造偏差與失敗調查：原則、實務與案例研究

本書探討了製藥產業中偏差和失敗調查的關鍵主題，認識到它們對監管結果的重大影響。廣泛的評估，包括對美國FDA警告信和483報告的分析，強調了進行強健調查的不可或缺性。本教科書徹底探討了進行科學基礎和數據驅動調查的標準工具和技術。其主要目標是闡明系統性調查方法論，以產生有效的糾正和預防措施，最終降低監管風險。本書提供了標準工具和技術的全面概述，專注於基於科學和數據驅動的方法。專為製藥製造專業人士量身打造，本書是您掌握患者關鍵製藥產品製造調查的首選資源。

Dr. Ajay Babu Pazhayattil, President, cGMPWorld, Toronto, Canada Dr. Ajay Pazhayattil is an accomplished management consultant and industrial pharmacist with extensive experience spanning solid oral, sterile, and API manufacturing sectors. He is the founder of cGMP World and a founding partner of ITAAN Pharma, an injectable manufacturer. Dr. Pazhayattil has held key leadership positions with prominent North American brands, generic manufacturers, and CDMOs. His roles include Vice President of Scientific and Regulatory Affairs at Capcium, Quality Director at Eurofins, and Associate Director at Apotex. He plays a pivotal role in guiding organizations through remediation efforts related to US FDA 483 observations and warning letters. He has been a lead author and contributor to industry guidance documents published by renowned industry organizations such as AAPS, PDA, ISPE, and RAPS. Sanjay Sharma, Senior Vice President and Head, Manufacturing Science and Technology, Zydus Group, Ahmedabad, India Sanjay is a seasoned pharmaceutical industry professional with over 25 years of experience in the development, launch, and maintenance of drug supply. He possesses a results-driven approach and a deep understanding of pharmaceutical manufacturing science, which has enabled him to contribute to the success of some of the largest organizations in the industry. Sanjay has held various leadership positions in Indian and multinational pharmaceutical companies such as Cipla, Dr. Reddy's Laboratories, Sandoz, Watson, Torrent, and Lupin. He is widely recognized for his expertise in streamlining technical operations and driving innovation to enhance product quality and regulatory compliance.

Ajay Babu Pazhayattil 博士，加拿大多倫多 cGMPWorld 總裁
Ajay Pazhayattil 博士是一位成功的管理顧問和工業藥劑師，擁有豐富的經驗，涵蓋固體口服、無菌及活性藥物成分（API）製造領域。他是 cGMP World 的創辦人，也是 ITAAN Pharma 的創始合夥人，該公司專注於注射劑的製造。Pazhayattil 博士曾在北美知名品牌、仿製藥製造商及合同開發與製造組織（CDMO）擔任重要領導職位。他的職位包括 Capcium 的科學與法規事務副總裁、Eurofins 的品質總監，以及 Apotex 的副總監。他在指導組織應對美國 FDA 483 觀察和警告信的整改工作中發揮了關鍵作用。他是多個知名行業組織（如 AAPS、PDA、ISPE 和 RAPS）發佈的行業指導文件的主要作者和貢獻者。

Sanjay Sharma，印度艾哈邁達巴德 Zydus Group 製造科學與技術部高級副總裁兼負責人
Sanjay 是一位經驗豐富的製藥行業專業人士，擁有超過 25 年的藥物供應開發、推出和維護經驗。他具備以結果為導向的方法和對製藥製造科學的深刻理解，使他能夠為行業內一些最大的組織的成功做出貢獻。Sanjay 曾在印度及跨國製藥公司（如 Cipla、Dr. Reddy's Laboratories、Sandoz、Watson、Torrent 和 Lupin）擔任多個領導職位。他因在簡化技術操作和推動創新以提升產品質量和法規合規性方面的專業知識而廣受認可。