QUALIFIED PERSON (TECHNICAL DIRECTOR)


The Qualified Person is the main person responsible for managing the A.T. laboratory activities and for ensuring compliance with all GMP rules as well as for the budget implementation. This position, therefore, requires a high qualification, that is specifies in the 2001/83 European Directive (1) as follows:

“A qualified person shall be in possession of a diploma, certificate of other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. However, the minimum duration for the university course may be three and half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of a least six months in a pharmacy open to public, corroborated by an examination at university level”.

Requirements for application for the Master in Manufacturing of Advanced Therapy Medicinal Products, Specialization as Qualified Person:

> Applicants should hold a University Degree following at least 4 years of study or a Bachelor Degree with a Major or Specialism in the biomedical field (pharmacy, medicine, veterinary medicine, biology, biochemistry or biotechnology)
> Applicants should demonstrate at least 6 months' experience in cell culture.

 MANUFACTURING MANAGER

The Head of the Manufacturing Department must guarantee that products are manufactured and stored according to SOPs and GMPs (2) in order to obtain the required quality. He/she is responsible for ensuring that appropriate validations are achieved as well as the required initial and continuing training of the personnel of his/her department is carried out and adapted according to need.

Requirements for application for the Master in Manufacturing of Advanced Therapy Medicinal Products, Specialization as Manufacturing Manager:

> Applicants should hold a University Degree following at least 4 years of study or a Bachelor Degree with a Major or Specialism in the biomedical field (pharmacy, medicine, veterinary medicine, biology, biochemistry or biotechnology)
> It is preferable that applicants should also have acquired practical experience in cell culture.

 QUALITY CONTROL MANAGER

The Quality Control Manager (2) is responsible for approving or rejecting, as appropriate, all starting and packaging materials, intermediate bulk as well as finished products. He/she is also responsible for approving specifications, sampling instructions, test methods and any other Quality Control procedures. He/she must ensure that the required initial and continuing training of the personnel of his/her department is carried out and adapted according to need.

Requirements for application for the Master in Manufacturing of Advanced Therapy Medicinal Products, Specialization as Quality Control Manager:

> Applicants should hold a University Degree following at least 4 years of study or a Bachelor Degree with a Major or Specialism in the biomedical field (pharmacy, medicine, veterinary medicine, biology, biochemistry or biotechnology)
> It is preferable that applicants should have acquired practical experience in quality control in laboratories.

 QUALITY ASSURANCE EXPERT

The Quality Assurance Expert is responsible for guaranteeing that the entire organised arrangements are carried out with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management incorporates Good Manufacturing Practice.(3)

Requirements for application for the Expert Degree in Quality Assurance for Manufacturing of Advanced Therapy Medicinal Products:

> Applicants should hold a University Degree following at least 4 years of study in the biomedical field (pharmacy, medicine, veterinary medicine, biology, biochemistry or biotechnology) or a Bachelor Degree with a Major or Specialism in biology, biochemistry or biotechnology.
> It is preferable that applicants should have acquired quality assurance experience or training in quality systems management.


References:
(1) Article 49, Directive 2001/83 of the European Parliament and of the Council of a 6 November 2001 on the community code relating to medical products for human use.
(2) Eudralex- Volume 4. Good Manufacturing Practice (GMP) Guidelines. Chapter 2 Personnel.
(3) Eudralex- Volume 4. Good Manufacturing Practice (GMP) Guidelines. Chapter 1 Quality Management.