5 SECTION 2. General Site Operational Information 2.11 Is the site registered with a public regulator (FDA registration, GMP certification, etc.)? If so, please indicate by whom the website is inspected (regulation or third parties) and list inspections in the last three years: 2.13 How often is the site reviewed annually by customers or third parties? 2.14 Please list regulatory sanctions that have affected the site over the past five years (i.e. warning letters, ECP suspension, import alerts, etc.): 2.15 Have there been any market withdrawals or approval orders in the past two years? 2.16 If so, please list and describe: Yes N/A 2.17 Does the website overlap with a quality-related activity? Yes N/A 2.18 If you answer yes to question 2.17, please indicate activities: 2.19 If you answer yes to question 2.17, are one of the following outsourcing controls: 2.19a Quality Contracts with Suppliers Yes N/A 2.19b Subcontractor Qualification/Audit Program Yes No N/A 2.19 Regular Supplier Performance Audit Yes N/A 2.19d Supplier Feedback Program 2.19th List of Raw Material Suppliers Ja N/A Ja N/A 5 The guide aims at: For example, external references and resources, as well as reasonable solutions to routine problems encountered during the quality agreement process. By providing perspectives for both suppliers and manufacturers, the guide provides a balanced vision that should help both parties reach a comprehensive and concise agreement. Flexibility and compromise are necessary to understand the demands of both parties and cooperate. Introduction of the questionnaire for raw material suppliers: this questionnaire was developed by the EHPM Quality Working Group. It combines the work done by EHPM, various national associations in development All stakeholders are invited to adopt and follow these recommendations in order to make QA a quality tool advantageous to customers and suppliers. The „supplier” is generally used in this document to refer to a company providing materials, products or services, including a sponsor. The quality agreement process can be one of the longer and longer efforts that suppliers and customers work together. Prolonged negotiations, misunderstandings and inflexibility often result in delays in the process, which can often take months and months.
4 SECTION 2. General information about implementation 2.1 How many years is the website in operation? 2.2 What is the main activity of the site? (for example. B manufacturing, distribution, etc.) 2.3 What is the parent company`s subdivision, if any? 2.4 Land size (in m2 or m.): 2.5 Please note the normal opening/hourly schedules of the facilities, including closing dates (if applicable): 2.6 Total staff on site: 2.7 Total number of employees in the quality unit? 2.8 Total number of people employed in manufacturing: 2.9 What quality management system is implemented in the field? ISO 9001 ISO CFR Part 210/ CFR Part 820 European GMP, Eudralex Volume 4 Part I European GMP, Eudralex Volume 4 PART II ICH Q7 HACCP ISO Other or Home-Grown system What regulatory initiatives does the site follow? REACH RoHs Ca Prop. 65 WEEE 2.10 Does the company have an export license? Yes N/A 4 Chapter 7 of the EU`s GMP guide on outsourced activities clearly sets out expectations for quality contracts. In the United States, few details have been given so far. In 2013, the U.S. Food and Drug Administration (FDA) released the Contract Manufacturing Arrangements for Drugs: Quality Agreements Industry Guidance Project. CFR regulations do not explicitly require contracting parties to document their respective responsibilities in contracting agreements, but the rules require that the responsibilities and procedures of the quality unit be written (21 CFR 211.22 (d)).