Qualified Persons
A qualified person shall be in possession of a diploma, certificate, or 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 of the university course maybe three and a 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 at least six months in a pharmacy open to the public, corroborated by an examination at the university level.
Where two university courses or two courses recognized by the State as equivalent co-exist in a Member State and where one of these extends over four years and the other over three years, the three-year course leading to a diploma,
certificate or other evidence of formal qualifications awarded on completion of a university course or its recognized equivalent shall be considered to fulfill the condition of duration referred to in the second subparagraph in so far as the diplomas, certificates, or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the State in question.
The course shall include theoretical and practical study bearing upon at least the following basic subjects:
– Experimental physics
– General and inorganic chemistry
– Organic chemistry
– Analytical chemistry
– Pharmaceutical chemistry, including analysis of medicinal products
– General and applied biochemistry (medical)
– Physiology
– Microbiology
– Pharmacology
– Pharmaceutical technology
– Toxicology
– Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin).
Studies in these subjects should be so balanced as to enable the person concerned to fulfill the obligations specified in Article 51.
In so far as certain diplomas, certificates, or other evidence of formal qualifications mentioned in the first subparagraph do not fulfill the criteria laid down in this paragraph, the competent authority of the Member State shall ensure that the person concerned provides evidence of adequate knowledge of the subjects involved.
The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal
products, quantitative analysis of active substances, and of the testing and checking necessary to ensure the quality of medicinal products.
The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.
Article 51
1. Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 48, without prejudice to his relationship with the holder of the manufacturing authorization, is responsible, in the context of the procedures referred to in Article 52, for securing:
(a) in the case of medicinal products manufactured within the Member States concerned, that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization.
(b) in the case of medicinal products coming from third countries, irrespective of whether the product has been
manufactured in the Community, that each production batch has undergone in a Member State a full qualitative
analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorization.
The batches of medicinal products which have undergone such controls in a Member State shall be exempt from the controls if they are marketed in another Member State, accompanied by the control reports signed by the qualified person.
2. In the case of medicinal products imported from a third country, where appropriate arrangements have been made by the Community with the exporting country to ensure that the manufacturer of the medicinal product
applies standards of good manufacturing practice at least equivalent to those laid down by the Community, and to ensure that the controls referred to under point (b) of the first subparagraph of paragraph 1 have been carried
out in the exporting country, the qualified person may be relieved of responsibility for carrying out those controls.
3. In all cases and particularly where the medicinal products are released for sale, the qualified person must certify in a register or an equivalent document provided for that purpose, that each production batch satisfies the provisions of this Article; the said register or equivalent document must be kept up to date as operations are carried out and must remain at the disposal of the agents of the competent authority for the period specified in the provisions of the
Member State concerned and in any event for at least five years.
Article 52
Member States shall ensure that the duties of qualified persons referred to in Article 48 are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct.
Member States may provide for the temporary suspension of such a person upon the commencement of administrative or disciplinary procedures against him for failure to fulfill his obligations.
EU Member States have to assure that each holder of a manufacturing authorization has to have at least one QP.
The following Guidances contain further requirements for the tasks to be fulfilled by a Qualified Person in Europe
EU GMP Guide to Good Manufacturing Practices
A Qualified Person is a technical term used in EU pharmaceutical regulation. The regulations specify that no Batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements. The QP is typically a licensed pharmacist, biologist, or chemist (or a person with another permitted academic qualification) who has several years of experience working in pharmaceutical manufacturing operations and has passed examinations attesting to his or her knowledge. In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed Responsible Person (RP) or Authorized Person (AP).
The QP is the person who accepts and signs off batches of medication to be released to the market or used in a clinical trial (for humans or animals). The role has a legal responsibility to ensure that every batch of a medicinal product released onto the market complies with its specification — i.e. complies with its marketing authorization and has been made according to good manufacturing practice. The QP will then release the batch onto the market. Each manufacturer of a human or veterinary medicinal product requires at least one QP to be named on their manufacturer’s authorization. The same processes apply in clinical trials.
The QP will usually spend their day working as part of the quality assurance team. Some of this time may be spent reviewing batch records and any deviations that occurred during manufacture or testing, with a view to certifying that the batch may be released for sale. Sometimes this may not be straightforward and the QP will request additional actions, such as further quality control analysis or even rework. On rare occasions, the QP will have to state that the batch must be destroyed. Other activities include meeting regulatory colleagues, clients, and marketing teams in project meetings, which could include discussions such as improving packaging or updating a formulation for the manufacture and testing of a product. Another day could be spent auditing the manufacturer of an active substance and checking that it is purchased from the site named on the relevant marketing authorization. The QP usually leads staff training in good manufacturing practices.
- Responsible for the QP certification of Drug Products and Intermediates, acting as the point of contact for queries relating to QP certification and batch release.
- Provides an efficient and effective service to support the timely release of products.
- Working with site management ensures that the site operates in a fully GMP compliant manner in accordance with all of the relevant legislation, as well as ensuring that the products and processes are fully compliant with the filed regulatory dossiers for the products supported.
- Working with the Quality Systems Manager ensures that the Quality Management (QMS) is fit for purpose.
- Engage in the self-inspection of the site QMS.
- Mentors others to expand on-site compliance knowledge.
- Supporting senior company leadership through QP decision-making to drive continuous improvement and fitness for purpose.
- Partners proactively with other sites in the supply chain to ensure that products and intermediates are received, released, and shipped in a timely and fully GxP compliant manner.
- Acts as the point of focus for all compliance inspections of the site e.g., internal, customer, and regulatory inspections.
Key Functions of the Role:
Product Batch release
- QP review and release for products imported from outside of the conutry to allow the sale of products in the country.
Supplier / Customer Compliance
- Ensure Quality Assurance (QA) requirements are met at all times by all 3rd party suppliers, service providers, and customers and Operational activities are compliant with authorized activities and scope detailed in GMP licenses, in order to support business continuity.
- Ensure Quality Assurance requirements are met for compliance as the Manufacturing Authorisation Holder for products.
Quality System Maintenance & Management
- Oversight of the management and maintenance of the Quality System (ensuring measures are in place to support good documentation practice and data integrity principles and effective governance of all company SOPs)
- Guidance to the business for the awareness of new and revision to existing quality directives within EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use.
- Manage the QMS performance level to maintain compliance with the MIA systems
Internal Compliance
- Oversight of employee training records and compliance of employee training with regulatory requirements, (including Controlled Drugs training).
- Ensure that QP training and continuing professional development are maintained on a personal basis
- Comply with relevant legal and compliance requirements, regulatory and ethical standards, and SOPs.
Line Management
- Responsible for line management of batch reviewer
- KPI setting and reporting
