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PIC/S Expert Circle Event on Quality Risk Management kicks off, Taiwan FDA continue to play a critical role of GMP regulation in the field of medicinal products

【Update Date:2018-09-10】 unit:風險管理組

The PIC/S Expert Circle on Quality Risk Management (QRM) & Training Event will take place in Taipei over three consecutive days from September 11 to 13. This is the fourth major Pharmaceutical Inspection Co-operation Scheme (PIC/S) event that the Taiwan Food and Drug Administration (Taiwan FDA) under the Ministry of Health and Welfare has hosted including it successfully held the PIC/S Committee Meeting and Annual Seminar in 2017. Participants include officials and inspectors from pharmaceutical regulatory authorities in Europe, America, Asia, Africa, and Australia, demonstrating the recognition of Taiwan FDA’s professional competence by PIC/S and its participating authorities and raising Taiwan’s profile in the international community.

The PIC/S Expert Circle Event on QRM aims to provide inspectors of medicinal products with advanced and consistent QRM training programme, to enable them to critically inspect the implementation and use of Quality Risk Management during regulatory inspections, effectively inspect QRM activities on site and use the PIC/S Recommendation in relation to risk-based GMP inspection planning, maximize inspection resources, conduct inspections more effectively, and ensure the safety of medicinal products.

This event includes a 2-day training course and a 1-day Expert Circle meeting. Internationally renowned experts, senior GMP inspectors, and experienced speakers from the industry have been invited from countries including the U.S., the U.K., Austria, Ireland, Iran, and Taiwan, and participants are key talents nurtured by GMP inspectorates worldwide. The curriculum is designed under the QRM framework, and consists of keynote speeches and multi-theme workshops, involve the topics of principles, tools and examples related to the implementation of QRM in industry, risk identification, data integrity etc. This event also provide a platform for participants to exchange information, share experience, revised related guidance documents and map out future plans for inspector training.

The quality of medicinal products has a significant bearing on people’s health and safety, and Good Manufacturing Practice (GMP) is a key component of quality management. PIC/S is the most authoritative and the only international organization made up of GMP regulatory authorities in the field of medicinal products. It aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP, from the materials, manufacturing process, storage, transportation, to distribution. PIC/S currently comprises 52 Participating Authorities from 49 countries in America, Europe, Asia, Africa, and Australasia. Taiwan FDA has become a Participating Authority of PIC/S since 2013.

Expert Circles have been set up by PIC/S to facilitate the discussions and the exchange of information among inspectors specialised in a specific area of GMP. Expert Circles meet regularly to develop draft guidance, recommendations, etc. and offer training in their respective fields of specialisation. Given that the supply chains of medicinal products are becoming increasingly complicated, QRM has been widely utilized in the pharmaceutical industry in order to identify and control potential risks and improve the decision making. The PIC/S Expert Circle on Quality Risk Management (QRM) was established in 2007. It has been active in developing models for QRM systems for Inspectorates as well as guidance on the assessment of QRM implementation in industry. Expert Circle meetings and training activities are held regularly to offer comprehensive training to inspectors to enable them to inspect QRM systems in a harmonised manner.