Pasteur Filiala Filipești gets GMP renewal
Production units that are part of the Pasteur Filipeștii de Pădure production group were recertified in January 2020 for the Good Manufacturing Practice standard, the most important validation that confirms the safety and quality of the pharmaceutical products. Granting of certification is conditioned on the implementation and compliance with certain GMP rules, principles and rules set out in Directive 91/412 / EEC.
The GMP certification of Pasteur Filiala Filipești units covers a complex set of systems in the areas of production, storage, quality, maintenance and validation of equipment, facilities and flows, staff training and biosecurity. To these are added the facilities of the factories and the configuration of the spaces - pharmaceutical white rooms and pharmaceutical utilities (purified water, HVAC ventilation and air treatment system, BMS, etc.). Pasteur Filiala Filipești was first GMP certified in 2017.
The unit produces both sterile and non-sterile products - injections, tablets, oral solutions, powders, suspensions and ointments. Its portfolio includes over 412 forms in 151 brands: antibiotics, anti-inflammatory, antiparasitics, hormonal, ophthalmic and otic products, vitamins, minerals and rehydrators, rodenticides, insecticides, cosmetics, disinfectants and detergents.
Pasteur Filiala Filipești has high-performance laboratories for microbiological and physico-chemical testing of raw materials and finished products, in accordance with the quality standards provided in the European Pharmacopoeia: HPLC laboratory, laboratory for stability studies and an interphase laboratory that analyzes product quality in different stages before packing. The laboratories are organized according to GLP (Good Laboratory Practice) standards, equipped with competitive equipment and flows in accordance with the standards in force. The total investments in the two production capacities of Pasteur Filiala Filipești amounted to over EUR 14 million.