Qualified Person responsibilities

The qualified person responsible for pharmacovigilance or persons working for or with this person. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

To have a qualified person responsible for phar-macovigilance. 

Marketing authorisation holder s role and responsibilities include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. The duties of the qualified person include ... 

Cold kits may also be prepared in a radiopharmacy similar to other medicinal products prepared in a pharmacy. The radiopharmacist then functions as the qualified person responsible for preparation of an official formula (formulation, pharmaceutical requirements, stability, etc.)... 

Directives 75/318/EEC and 75/319/EEC, amended at different times from the original version, state the documents and requirements for manufacture and marketing authorization. Definition of the professional profile of the qualified person responsible for the quality of medicinal products is presented, and a technical body on medicines, the Committee of Proprietary Medicinal Products (CPMP), is created. Due to technical reasons, some products such as vaccines and sera, homeopathics, hemoderivatives, and radiopharmaceuticals were excluded from the scope of this directive in its original version. 

I. The qualified person responsible for releasing batches should have a thorough knowledge of the production and control of medicinal gases including practical experience. All personnel should know the GMP relevant to medicinal gases and should be aware of the critically important aspects and potential hazards for patients from medicinal products in the form of gas. 

The contract shall dearly define the responsibilities of each party and in particular the duty of the contract acceptor to observe good manufacturing practice and the manner in which the qualified person responsible for releasing each batch shall undertake his full responsibilities. 

Quality defects are reported often by the patient to a physician, to the pharmacist and to industry. Such complaints come to the attentirm of the QP and the Qualified Person responsible for Pharmacovigilance... 

The investigations must be performed under the responsibility of a medical practitioner or other authorised qualified person (e.g. dentist). 

The identity and qualifications of the person responsible for product release (a Qualified Person ). 

In the EU, a basic requirement for marketing authorisation holders (MAHs) is that they must have permanently and continuously at their disposal a nominated qualified person, with responsibility for pharmacovigilance. This person should have experience in all aspects of pharmacovigilance and, if not the holder of a medical or veterinary qualification, they should have access to such a person. The duties of the qualified person include ... 

Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent. 

Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 21 of Directive 75/319/EEC, without prejudice to his relationship with the manufacturer or importer, is responsible, in the context of the procedures referred to in Article 25 of the said Directive, for ensuring ... 

When outside agencies are used to provide a computer service, there should be a formal agreement including a clear statement of the responsibilities of that outside agency [13]. When the release of batches for sale or supply is carried out using a computerized system, the system should allow only a qualified person (QP) to release the batches and it should clearly identify and record the person releasing the batches. This is possible by giving the QP an operational level in the computer system that allows it to release batches. No other person should have the same operational level authorization as the QP. 

In order to establish and maintain a pharmacovigilance system, the holder of the marketing authorization is required to have permanently and continuously at his or her disposal an appropriately qualified person. This qualified person is personally responsible for ensuring that information about all adverse reactions that are reported to the personnel of the company and to medical representatives is collected and collated. This qualified person is also responsible for ensuring that all suspected serious adverse reactions are reported to the competent authority concerned. 

Maintenance of an impeccably clean storeroom and good physical organization that are essential for the preservation of the fabric collection is impossible without qualified personnel. Selection of a caretaker (not to be confused with the person responsible for the upkeep of the museum building) is likely to be very difficult. As the museum fabric field is not an established professional area, it is best to train an individual according to his or her ability and development. At the outset, he must be sensitive in touch and vision, have a strong sense of cleanliness and neatness, and also an ability to tolerate tedious routines. The position should not be filled casually by any job applicant who comes along. 

That qualified person in charge of, and responsible for, the loading and firing of a blast (same as shot firer). 

Editorial responsibility and authority for any manuscript authored by an editor and submitted to the editor s journal should be delegated to some other qualified person, such as another editor of that journal or a member of its Editorial Advisory Board. Editorial consideration of the manuscript in any way or form by the author-editor would constitute a conflict of interest, and is therefore improper. 

As for manufacturing of other pharmaceuticals, a system should be established to verify the quality of the starting materials used in manufacturing radiopharmaceuticals. This system must assure that no material is used for production until it has been released by a competent person [qualified person (QP) or others given this responsibility]. 

QA must approve Validation Reports. For European pharmaceutical and healthcare compaiues this is likely to be a responsibility of the registered Qualified Person. ... 

A person (among key personnel of a manufacturing establishment) responsible for the release of batches of finished products for sale. In some good manufacturing practice (GMP) guides and legal texts, the term qualified person is used to describe analogous functions. 

Such support can involve responding to complaints about promotional activities, which may come from other companies or external agencies such as, in the UK, the Prescription Medicines Code of Practice Authority. A medically qualified person should certainly have overall responsibility for clinical drug safety issues (see Section 9.3.6). Pharmaceutical physicians are usually involved in the training of sales representatives. In addition, a good pharmaceutical physician can be a credible ambassador for the company when lecturing to external audiences or dealing with the communication media. 

The holder of the authorization must have at its disposal at least one qualified person (QP) who is authorized in the particular MS, to continue working permanently and continuously and providing expert services as laid down in the GMP Directive and detailed guidelines (see Table 1, p. 550). The QP is directly and independently responsible for satisfying him/herself of the purity and quality of production batches of the IMP manufactured locally or in a non-EU country. Where an IMP is a comparator... 

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