Certificazione GMP

Good manufacturing practices (GMP) sono le pratiche richieste per conformarsi alle linee guida raccomandate dalle agenzie che controllano l'autorizzazione e la concessione di licenze per la produzione e la vendita di alimenti e bevande, cosmetici,prodotti farmaceutici,supplementi dietetici,e dispositivi medici.

These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; Tuttavia, the main purpose of GMP is always to prevent harm from occurring to the end user.

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gcp certificate


GLP certification

Good Laboratory Practice course

In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.

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gcp certificate

GVP certification

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (Unione Europea). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

Guideline on GVP
The guideline on GVP was a key deliverable of the pharmacovigilance legislation.

Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States.

The guideline on GVP is divided into chapters that fall into two categories:

modules covering major pharmacovigilance processes;
product- or population-specific considerations.
Modules covering major pharmacovigilance processes

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gcp certificate

Certificazione PIL

Good distribution practice (PIL) is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. It regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

congressi medici
gcp certificate


NBScienza

organizzazione di ricerca a contratto

terapia con cellule staminali