It was already covered in the previous blog the extent of the legal responsibilities of the Qualified Person. However, they do not cover the total professional responsibilities of the QP. The regulatory authorities' perception of the routine duties of the Qualified Person is to be found in Section 8 of Annex 16 for marketed products and in Section 40 of Annex 13 for investigational medicinal products.
Prior to affirming a cluster preceding delivery the QP doing as such ought to guarantee that basically the accompanying prerequisites have been met:
- the group and its assembling consent to the arrangements of the advertising approval (counting the approval needed for importation where significant)
- the manufacture has been done as per Good Manufacturing Practice or, on account of a batch imported from a third country, as per great assembling practice principles essentially identical to EU GMP
- the chief assembling and testing processes have been approved; account has been taken of the real creation conditions and assembling records
- any deviations or arranged changes underway or quality control have been approved by the people mindful as per a characterized framework. Any progressions expecting variety to the showcasing or assembling approvals have been advised to and approved by the applicable power
- all vital creation and quality control documentation has been finished and supported by the staff approved to do as such
- all reviews have been done as needed by the quality affirmation framework
- the QP ought to furthermore consider some other elements of which he knows which are applicable to the nature of the cluster
Assessment of each batch for certification prior to release may include as appropriate:
- batch records, including control reports, in-process test reports, and release reports demonstrating compliance with the product specification file, the order, protocol, and randomization code. These records should include all deviations or planned changes, and any consequent additional checks or tests, and should be completed and endorsed by the staff authorized to do so according to the quality system;
- production conditions;
- the validation status of facilities, processes and methods;
- examination of finished packs;
- where relevant, the results of any analyses or tests performed after importation;
- stability reports;
- the source and verification of conditions of storage and shipment;
- audit reports concerning the quality system of the manufacturer;
- documents certifying that the manufacturer is authorized to manufacture investigational medicinal products or comparators for export by the appropriate authorities in the country of export;
- where relevant, regulatory requirements for marketing authorization, GMP standards applicable and any official verification of GMP compliance;
- all other factors of which the QP is aware that are relevant to the quality of the batch.
The relevance of the above elements is affected by the country of origin of the product, the manufacturer, and the marketed status of the product (with or without a marketing authorization, in the EU or in a third country) and its phase of development.