About

Organisation

General Assembly Members

FECC, IPEC-Americas, IPEC-China, IPEC Europe, PQG, SPPEA who have full and equal voting rights at formal meetings of members. Other individuals and organisations who have experience of and interest in pharmaceutical excipients may be considered for Associate membership. Associate members have no voting rights at formal meetings of members.

Board Members

Board Member Ms Jessica Nicole Cansler, representing IPEC-Americas
Board Member Ms Shine Gao, representing IPEC China
Treasurer Mr Kevin McGlue, representing IPEC Europe
Board Member Dr Morad Amadji, representing IPEC Europe

 

Operations

Quality Manager Mr Alain Becart, Consultant
Senior Adviser Mr Adrian L. Bone, Expert
Administrative Coordinator Ms Bosele Basunda (Chimene Bosele), EXCiPACT Secretariat

Meet The Board

Morad Amadji, President

Morad is a Doctor Es Sciences in Chemistry by education, he has an extensive scientific, operational, and managerial experience in the pharmaceutical industry covering development, manufacturing as well as supplier management for pharmaceuticals, vaccines, and biotech products. He has more than 25 years of experiences in various pharma Co mainly in 3 areas; 8 years in R&D including molecules synthesis and safety process, 8 years in Analytical Development & Quality Control and 8 years in Quality Assurance Specialist.

Certified GMP and API Auditor, Morad participated in several GMP and for cause audits as well as interacted with FDA, ANSM and other health authorities during inspections. In his current position, he leads and manages the team of corporate quality auditors for ensuring an efficient quality management of suppliers and contractors used for manufacturing Sanofi products and materials.

Shine Gao, Vice President

Shine Graduated from China Pharmaceutical University in 2010, majoring in Pharmaceutical Analysis, with 8 years of quality management experience in drug manufacturing company. Familiar with pharmaceutical GMP quality management system, like change control, deviation investigation, CAPA system, supplier management etc.

From 2018 to now, Shine worked in pharmaceutical excipient industry, mainly responsible for China CDE registration, quality, and technical support. Familiar with excipient GDP regulations,  she has established and maintained a set of quality management systems for distributors. In her spare time, she also serves as the Chairman of the IPEC China Quality Sub-Committee and as a technical expert on excipient GMP for DQS, a third-party certification body.

Kevin McGlue, Treasurer

Kevin is a graduate in Chemistry and started his working career first as a Research & Development Chemist, then as a Process Chemist. He then spent six years as a Chemical Synthesis Plant Manager, and Formulations & Packing Manager managing a wide range of chemical synthesis and formulation activities for Schering A.G. He joined Colorcon in 1987, spending 11 years as Operations Manager and 8 years as Operations Director responsible for all Operational activities for Colorcon EMEA. In February 2006, he took up a new position as Director, Global Quality Assurance with overall responsibility for all QA and QC activities worldwide. In March 2022, Kevin retired from Colorcon.

Kevin is Treasurer of EXCiPACT asbl. He was EXCiPACT President from 2016-2019 and then continue to support the organisation in an expert quality. He is a former member and Vice-Chair of the Board of IPEC Europe and a past Chair of the IPEC Europe GMP committee. He was a member of the IPEC team responsible for the production of the 2006 Joint IPEC / PQG Excipient GMP guide, and led the task force for the 2017 revision. Kevin has published numerous articles on Excipient GMP and Change Management and is a regular speaker at seminars, conferences and training courses.

Jessica Nicole Cansler, Board Member

Jessica holds a master’s in jurisprudence in Health Law from Seton Hall University and B.S. in Biomedical Engineering from Rutgers University. She has held various roles in Quality and Engineering within the Pharma and Biologics industries. She started her career at BASF in Sep 2011 as Quality Management Specialist for the North America region, gaining experiences in various quality realms and represented BASF’s Quality interests in various trade organizations (i.e., IPEC Americas, ASQ, etc.)

Jessica is now a Quality Compliance Manager for BASF Global Quality Governance. She is an America Society of Quality (ASQ) Certified Quality Auditor. As a member of IPEC America, she functions as the lead for the Education Strategy team and serve as an active contributing member for the GMP, Excipient Qualification, and QbD committees

Meet The Operations Team

Iain Moore, Senior Advisor

Iain was Global Head of Quality Assurance Croda Europe Ltd, a manufacturer of speciality and performance chemicals based in the United Kingdom. He  worked for Croda for 36 years, and for more than 25 years in various quality roles, including overseeing two UK regulatory inspections.  He has contributed to the publication of European and US National Standards as well as many IPEC Guides. He was project leader for the development and delivery of the EXCiPACT Certification Scheme, and stood as its first President, and has latterly returned to the Board as President and Chairman of the Board succeeding Kevin McGlue from 2016 to 2022. He is also  chair of the EFFCI (European Federation for Cosmetic Ingredients) GMP Committee which oversees the EFfCI GMP Guide and standard for cosmetic Ingredients.

Alain Becart, Quality Manager

Alain has a Doctorate in Industrial Pharmacy and a Masters degree in Analytical Chemistry and Quality Control. He started his career as Head of Quality Control in Pharmaceutical Manufacturing with the French offices of Ethypharm and Boehringer Ingelheim. In 1995, he joined Rhone Poulenc Rorer (a Sanofi legacy company) in their R&D – Analytical Sciences department with responsibility for clinical batches analysis and stability testing.

In 2005, he became responsible for Suppliers Quality Management worldwide within the Industrial Quality & Compliance corporate department Sanofi-Aventis, where he built a global system to manage the quality of third parties, including audits of manufacturers and distributors of pharmaceutical starting materials. He retired in October 2017 as Director Quality of Third Parties in SANOFI Global Quality based in Paris.

Since 2010, Alain has been President of the Pharmaceutical Starting Material Forum within the Quality Group of the LEEM - the professional organisation of pharmaceutical companies operating in France. In January, 2017, he became the Quality Manager of EXCiPACT asbl with responsibility for the approval of their Registered Certification Bodies and Registered Auditors, and for ensuring compliance of EXCiPACT certification actions with regards to ISO 19011 and ISO 17021 standards.

Membership

Under the Articles of the Association, full Membership of EXCiPACT asbl can only be granted to trade associations or similar organisations that represent groups of organisations who have an interest in manufacturing, distributing or using pharmaceutical excipients, and Competent Authorities responsible for upholding safety and quality standards for excipients. All those interested in becoming a member should contact the EXCiPACT Secretariat at info@excipact.org or complete our contact form in the first instance.

Quality Policy

The EXCiPACT Association is committed to achieving excellence and providing our entire community supply chain with a set of high-quality services designed, produced, and maintained to meet or exceed their expectations.  You can read about our Quality Policy here.

Corporate Governance

EXCiPACT asbl is a Belgian not-for-profit association following the rules set by the Articles of Association. To support the values and related perceptions of our industry, it is essential that EXCiPACT asbl not only complies with statutory provisions and legal requirements regarding the essential features of the association (e.g. conduct of non-profit activities, fulfilment of the financial / taxes obligations), but also operates to the highest level of ethical standards. Our Governance and Compliance Policy reflects this.

Useful Links

The links on this page connect to sites which EXCiPACT believes may be useful to its website readers. EXCiPACT is not responsible for the content of any of the external sites listed. 

Regulatory Agencies

Industry Associations