De Jong Pharma Consult: Since 2011 your Quality Assurance  service provider for the Pharmaceutical Industry

Boudewijn de Jong graduated in 1994 as a chemical engineer at the University of Eindhoven. He started in 1995, immediately after his dismissal for military service, as Trainee at Diosynth BV, a globally operating API supplier. This position held a wide range of management activities including management of a production department and a warehouse. Through his career in the production of APIs and the development of new products and processes, experience in management and development of new systems was obtained, also in quality. In addition to this work he studied Organic Chemistry at the Universities of Utrecht and Leiden.

From 2005 to 2011 he worked at NV Organon in Oss, the countries largest pharmaceutical company. In his role as Senior Quality Officer for the production organization in Oss he was key in the development of the quality system The implementation and maintenance of the quality system was a natural next step. In this period he has gained a lot of (internal and external) audit experience.

Transition from NV Organon to first Schering-Plough and later Merck Sharp & Dohme (MSD/Merck) meant the redevelopment and implementation of new and changing pieces of the pharmaceutical quality system. Extensive experience with the ‘American way’ of dealing with quality was obtained.

Initially in 2008 and 2009, with the completion and qualification of a new sterile production facility, and later in 2010, when upgrading an existing parenteral factory, Boudewijn ensured the quality and compliance of the project successfully, which lead to subsequent approval by the Dutch Health Authority. Both approvals were completed without findings.

In 2011, Boudewijn started with De Jong Pharma Consult. A business with a focus on providing Quality Assurance services to the pharmaceutical industry. De Jong Pharma Consult is a versatile company that can help you achieve your goals. The services of De Jong Pharma Consult can be distinguished in ‘Supplier audits’, ‘Hosting Inspections’, ‘Consultancy’, ‘Training’ and ‘Internal Audits’. Since 2019, Boudewijn can function and be registered as a ‘Responsible Person’ as prescribed in the European Good Distribution Practices guideline.

Over the years, over 350 internal audits and over 650 supplier audits were conducted for over 30 pharmaceutical and medical device related clients, numerous auditors were trained and thousands of pages of documentation reviewed.

With expertise in the following regulations:
Drugs:

• 21 CFR 210, 211, 212
• ISO 9001, 11135, 11137, 11138, 15378, 17025, 19001
• Eudralex Volume 4, parts 1, 2, 3 and all annexes
• EU Regulations: Serialization, Falsified Medicines, Good Distribution Practices
• ICH guidelines Q 7, 8, 9, 10, ISPE guidelines
• Korean and Japanese GMP
• Expert in radiopharmaceuticals, biomarkers and PET tracers

Medical Devices

• 21 CFR 820
• ISO 13485, 14971
• EU Regulations: Medical Device (MDR)

De Jong Pharma Consult is your partner in Pharmaceutical and Medical Device Quality Assurance