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國外藥品原料供應商質量評估調查表-英文版.docx 16頁

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XXXXXXXX Pharmaceutical Co., Ltd. PAGE Files No.:HZHWYY-WL-SOR-002-01 page PAGE 1 of 16 北京紅惠生物制藥股份有限公司 GMP·設備文件 QUALITY QUESTIONNAIRE Instructions: Please answer all questions and return this questionnaire before the date established by your contact. If you have a documented procedure that covers the context of the question state its title and reference. If you require more space to answer a question do not hesitate to attach additional sheets as an appendix and reference the relevant section. If questions are not applicable for your operations, please answer “N/A”. If required documents are not available, please answer “N/Av” Please enclose to your reply, your company organisation chart. I-GENERAL INFORMATION I-A Name and address of the company – manufacturing site: Company Manufacturing Site: Full Name Address Additional Information City Code&City Name State-Country Phone number Fax number : E-mail: I-B corporate status (if applicable) Company Head Quarter: Full Name Address City Code&City Name State-Country Phone number Fax number: E-mail: I-C Name and position of the main contacts: (please provide business card) Sales/commercial: Name____________________ Position:___________________ E-mail:_________________ Quality: Name____________________ Position: ___________________ E-mail: _________________ Name____________________ Position: ___________________ E-mail: _________________ I-D Site: Number Total area of the site Total area of the buildings Age of the buildings Total number of employees for the plant Number of employees for Production dept In how many shifts is production working? Number of employees for Quality Departments: Quality Assurance dept Quality Control Laboratories: In how many shifts is Quality Dept working? Number of employees for Research and Development: =>Please supply a general site layout in addendum to

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