We offer assistance in design and implementation of the different quality assurance systems in Pharmaceuticals and Biologicals. We draft procedures and other related documents with the support of site managers.
We ensure that individual Q.A system has its owner, bounderies , inputs and outputs from other departments as well as appropriate timelines. FDA identify frequently significant compliance issues concerning the main Q.A systems that are not operating under appropriate control ( e.g. deviation change control, CAPA plan , etc ... ).
The Director of GMP BIOPHARMA CONSULT SPRL followed 2 intensive training sessions on system based inspection in USA.
We offer consultancy in current good manufacturing practices ( CGMP ) used in the industry for the different dosage forms.
GMP experience acquired in the top 5 pharmaceutical leaders will be shared with our customers as well the implementation approach of the applicable regulations i.e. 21CFR 210-211 and 21CFR 600-610 for Biologicals ( US ) and Eudralex Directives 2003/94/EC and 91/412/EC requirements. (EU)