Elimination of unnecessary human errors, decreased work efficiency, and breaking away from outdated SOPs - SOP format data (Word) + explanatory book (ebook)
【eBook version】 For details and applications for this product, please check our website. https://www.science-t.com/ebook/27312.html *No application download is required for the Word format. (Membership registration is necessary) 【Downloadable SOP Word Data】 *Our company cannot be held responsible for any troubles or issues arising from the use of this format data. Please use it at your own risk. ● SOP format for the foundation of GMP-SOP ● SOP format for CAPA ● SOP format for deviation management ● SOP format for laboratory management ● SOP format for cleaning methods ● SOP format for clean rooms ● SOP format for pharmaceutical packaging ● SOP format for maintenance inspection management ● SOP format for supplier management ● SOP format for shipping determination, recalls, and complaint handling
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■Authors Hideaki Hitomi (HitoMi Life Science Research Institute, formerly Pharmaceuticals and Medical Devices Agency) Yoshikane Wakayama (Takatsuki Pharmaceuticals/Food GMP/ISO Research, formerly Shionogi & Co., Ltd.) Akira Nomura (QA Advisor/Consultant, formerly Shionogi & Co., Ltd.) Shigeo Kawada (NPO Pharmaceutical and Food Quality Assurance Support Center, formerly Dainippon Sumitomo Pharma Co., Ltd.) Akimasa Nagaoka (formerly Shionogi & Co., Ltd.) Mitsuo Sakamoto (Akiyama Tablets Co., Ltd., formerly Eisai Co., Ltd.) Katsunori Okada (formerly Shionogi & Co., Ltd.) ■Table of Contents Chapter 1: SOP Format for SOPs that Serve as the Foundation for GMP SOPs Chapter 2: SOP Format for CAPA Chapter 3: SOP Format for Deviation Management Chapter 4: SOP Format for Record Keeping and Management in Testing Laboratories Chapter 5: SOP Format for Cleaning Methods Chapter 6: SOP Format for Worker Behavior Regulations in Clean Rooms Chapter 7: SOP Format for Pharmaceutical Packaging Processes Chapter 8: SOP Format for Appearance/Visual Inspection Chapter 9: SOP Format for Maintenance and Inspection Management Others
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