Services
The main activities of Pelfort Pharma Consultant are interim management in the field of Quality Assurance, Quality Control and production departments and providing services as a Qualified Person or Responsible Person, for a short or long term, for the benefit of multinationals, small and medium businesses and start-up companies operating in various areas (e.g. human and veterinary medicines).
Start up organisation support in case a pharmaceutical company is seeking to establish a subsidiary within the EU for importation of medicines. So this will result in a company with a manufacturing and importation license fully compliant to the EU GMP guidelines.
Pelfort Pharma Consultant can be your partner for the design and implementation of cost effective GxP related Quality systems, designing a completely new Quality system, consisting of a documentation system, Site Master Files, Product Quality reviews, Quality risk management, deviation management (e.g. root cause determination), complaint management, CAPA management (e.g. human error assessment and CAPA effectiveness) and validation management (e.g. cleaning validation and Validation Master Plan).
Pelfort Pharma Consultant can also be your partner in pharmaceutical engineering projects, such as conceptual, basic and detailed design phases, the construction of production and distribution facilities and validation programs of these new facilities. To sustain the project, Pelfort Pharma Consultant works with and helps site personnel to ensure that the quality system requirements are met, also after the project has been completed.
Pelfort Pharma Consultant offers training on Quality management, GMP/GDP related topics (e.g. QP on the job training, change control, deviations and validation) and the Edufarma foundation course Farmaceutisch Vakman. These in-house training sessions will be custom made with respect to contents and duration.
Beside the fact that training is required in a GxP compliant environment, in-house training is also the best way to motivate your team. The training duration may vary (from half a day to five days) and training may be a single or a recurrent event. Training sessions will contain various precedents and study cases. Optimum attendance is 5 to 15 persons.
With Jurgen van Turnhout being Pelfort Pharma Consultant’s managing director and sole shareholder, Pelfort Pharma Consultant offers 20 years of professional experience in performing third party audits (as accepted by the relevant authorities) of medicine manufacturers (veterinary and human), packaging materials, raw materials manufacturers (API/excipient), distributors, contract manufacturers and contract laboratories.
Pelfort Pharma Consultant BV performs audits in two different ways one is the commissioned audit, in which a specific client requests to audit a specific supplier and the other is the open audit in which Pelfort Pharma Consultant performs an audit per supplier and the report is made available for sale. This last option is both beneficial for the suppliers as for the pharmaceutical manufacturers. The suppliers only have one audit for the complete site so a very limited of resources needed to support these audits (instead of multiple audits of e.g. relative small customers). The manufacturers on the other hand can also reduce their costs, because the reports are made available for a reasonable price.
The aim of the audits is to offer an independent source of information on the GMP compliance status and it will be a ‘turnkey’ audit, including organization, conduct and evaluation of the audit (e.g. including API GMP declaration).
There are three basic principles of the audits conducted on EU GMP part I or II, EU GDP and ISO15378: minimized costs for standardized audits; standardized process for preparing and performing audits; and release of audit report within a week after the audit.
Portfolio
Profile
Jurgen van Turnhout
Managing director and sole shareholder of Pelfort Pharma Consultant B.V
In the summer of 2014 at Pelfort, Miremont, France, the idea arose to establish Pelfort Pharma Consultant B.V.
Jurgen van Turnhout is a Doctor of Pharmacy with a 5 years experience in hospital pharmacy and over 20 years experience as head of different Quality organizations of various sizes within several companies.
As a Qualified Person as of the year 2000, he supports and advises the pharmaceutical industry, related healthcare industry and hospital pharmacies in respect of quality related subjects.
“Simplicity is the ultimate sophistication”
– Leonardo da Vinci –
Contact
Jurgen van Turnhout, Pharm.D.
Pelfort Pharma Consultant B.V.
Kerklaan 13, 4063CV Heesselt, The Netherlands
Chamber of Commerce number: 61429414
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