Prior to Amgen, Barbara worked for the consulting firm Don Hill and Associates, which provides regulatory and quality services to the pharmaceutical industry and Eli Lilly and Company in quality and regulatory matters CMC. She began her career in the pharmaceutical and 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 email@example.com. 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. Introduction of the questionnaire for raw material suppliers: this questionnaire was developed by the EHPM Quality Working Group. It combines the work of the EHPM between different national associations in development In order to ensure that sponsors can have confidence in the data generated by their contract manufacturers and their laboratories, several activities are needed.
The promoter must carry out appropriate due diligence assessments and meet qualification criteria. Regular monitoring should be described and implemented, and the proponent should document and justify the data on which it will rely on the decisions to release the draw. The explanatory statement should include the reasons why the entity is supposed to believe that the data provided by the contract website is trustworthy and that this is guaranteed at all times. Regular on-site audits become more important when verifying the original data, as the sponsoring company will generally not verify the original specific data. On the contrary, they base their decisions on certificates of analysis supplemented by specific information agreed in the quality agreement or in the contractual agreement. Barbara Unger founded Unger Consulting, Inc. in December 2014 to provide GMP audit and regulatory recognition services to the pharmaceutical industry, including auditing and remediation in the area of data management and data integrity. His audit experience includes the management of the Amgen Corporate GMP audit group for APIs and quality systems. She also developed, implemented and maintained the GMP Regulatory Intelligence Program at Amgen for eight years.
These include monitoring, analysis and communication of GMP legislation, rules, guidelines and trends in the application of compliance rules in the sector. Barbara was the first chair of the Rx-360 Monitoring and Reporting Working Group (2009-2014), which summarized and published relevant BMP and supply chain laws, regulations and guidelines. From 2010 to 2014, she chaired the GMP-Intelligence subgroup of the Midwest Discussion Group. Barbara is currently co-director of the Rx-360 Data Integrity Working Group. This quality agreement best practices guide aims to help customers and suppliers effectively manage the initiation, negotiation, implementation and day-to-day maintenance of quality agreements. Such agreements generally exist between drug manufacturers and their suppliers of equipment and services (i.e. manufacturers of APIs, additives, packaging materials, etc., as well as suppliers of GxP, analysis or other services for drug manufacturers. 4 Section 2. General information on 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 on the ter