4 SECTION 2. General site operating information 2.1 How many years is the site already in operation? 2.2 What is the main activity of the site? (for example. B production, distribution, etc.) 2.3 What is the sub-department of the parent company, if any? 2.4 Site size (in square feet or m²): 2.5 Please indicate normal opening hours/facility schedule, including closing dates (if applicable): 2.6 Total number of employees on site: 2.7 total number of employees in the quality unit? 2.8 Total number of employees in manufacturing: 2.9 Which quality management system is used on site? ISO 9001 ISO CFR Part 210/ CFR Part 820 European GMP, Eudralex Volume 4 Part I European GMP, Eudralex Volume 4 Part II JE Q7 HACCP ISO Other system or house What regulatory initiatives follow or fill the site? REACH RoHs Ca Prop. 65 WEEE 2.10 Does the company have an export licence? Yes No N/A 4 „Supplier” is generally used in this document to refer to a company that provides materials, products or services, including a sponsor. The quality agreement process can be one of the longer and more back-and-forth efforts that suppliers and customers collaborate. Longer negotiations, misunderstandings and inflexibility often lead to delays in the process, which can often take months and months. Prior to Amgen, Barbara worked for the consulting firm Don Hill and Associates, where she provided regulatory and quality services to the pharmaceutical industry, and for Eli Lilly and Company in the areas of quality and regulatory affairs CMC. She began her career in the pharmaceutical/equipment industry at Hybritech Inc. and earned a bachelor`s degree in chemistry from the University of Illinois at Urbana-Champaign. You can contact Barbara at the bwunger123@gmail.com. 5 SECTION 2.

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