The Role of the Qualified Person in European Pharmaceutical Regulations.

The Role of the Qualified Person in European Pharmaceutical Regulations.(EudraLex Vol:4)

The role of the Qualified Person In European Pharmaceutical Regulations As per EudraLex Volume 4; Chapter 2 :- Personnel. The duties of the Qualified Person(s) are described in Article 51 of Directive 2001/83/EC, and can be summarised as follows:

a) for medicinal products manufactured within the European Union, a Qualified Person must ensure that each batch 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 authorisation;

(b) in the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the European Union a Qualified Person must ensure 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 authorisation. The Qualified Person must certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51.

The persons responsible for these duties must meet the qualification requirements laid down in Article 493 of the same Directive, they shall be permanently and continuously at the disposal of the holder of the Manufacturing Authorisation to carry out their responsibilities.

The responsibilities of a Qualified Person may be delegated, but only to other Qualified Person(s).

Guidance on the role of the Qualified Person is elaborated in Annex 16.

The head of the Production Department generally has the following responsibilities:

i. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;

ii. To approve the instructions relating to production operations and to ensure their strict implementation;

 iii. To ensure that the production records are evaluated and signed by an authorised person;

iv.To ensure the qualification and maintenance of his department, premises and equipment;

v. To ensure that the appropriate validations are done;

vi. To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.

Reference :-

The Rules Governing Medicinal Products in the European Union Volume 4
EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and Veterinary Use
Part 1
Chapter 2: Personnel

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