(1999; 168 pages) [Spanish]
1. The role and position of the authorized person in the company
The authorized person as the overall quality controller will be a member of a team whose function includes the following major areas:
- implementation (and, when needed, establishment) of the quality system;
- participation in the development of the company's quality manual;
- supervision of the regular internal audits or self-inspections;
- oversight of the quality control department;
- participation in external audit (vendor audit);
- participation in validation programmes.
Although authorized persons may not have line management responsibility for many activities within this function (although they should be involved in these activities as much as possible), they must be aware of any changes that may affect compliance with technical or regulatory requirements related to the quality of finished products. When any aspect of the company's operations is not in accordance with GMP guidelines or relevant legislation in force, the authorized person must bring this to the attention of senior management. This duty should be reflected in the authorized person's job description.
The availability of an authorized person should be a prerequisite for issue of a manufacturing licence (authorization). The authorized person (as well as persons responsible for production and quality control) must be approved by the drug regulatory authority. The licence holder is obliged to inform the drug regulatory authority, or other responsible authority depending on national (regional) regulations, immediately if the authorized person is replaced unexpectedly. Such provisions will assure to a considerable degree the independence of the authorized person from the management of the company in the fulfilment of his or her duties even when under pressure to depart from professional and technical standards.
As indicated in the GMP guidelines published by WHO, in certain countries, depending on the national legislation or regulations, two authorized persons are designated: one for production and another for quality control. A company may have a complex structure, or operate at several locations, or both, and sometimes a separate authorized person may be designated who is responsible for the manufacture of clinical trial materials. Consequently it may be necessary to nominate several authorized persons, one of them having the responsibilities of the overall quality controller and the others responsible for site or branch operations. The person authorizing batch release should be independent from production activities.
The drug regulatory authority should approve the authorized person on the basis of his or her professional curriculum vitae. Authorized persons have duties not only to their employer but also to the competent authorities such as the drug regulatory authority. They should establish good working relations with inspectors and as far as possible provide information on request during site inspections.
The authorized person depends upon many working colleagues for the achievement of quality objectives, and may delegate some duties to appropriately trained staff while remaining the overall quality controller. It is therefore of paramount importance that he or she establish and maintain a good working relationship with other persons in positions of responsibility, especially those responsible for production and quality control.