GMP BIOPHARMA CONSULT SPRL offer assistance in preparation and support during the EMA and FDA inspections for the following kind of inspections :
- APIs ( Drug Substance ) -ICH Q7.
- Drug Products ( solid, liquid, aseptic and sterile products ). Pre-approval (PAI) and routine inspections ( for US, 21CFR 210 and 211 ) and FDA guidance for sterile products )
- Biological Medicinal Products ( for US, 21CFR 600 and 610 )
- Drug products ( all dosage forms ) for Europe ( Eudralex - Directive 2003/94/EC for human use ).
- Veterinary Drugs ( for Europe - Directive 91/412/EC )
We offer in-depth assistance through a " 3 steps " process :
- In-depth audit to assess and identify Quality issues.
- Implementation of quality improvements plan with site and prepare staff for inspection. People involved are trained to provide the appropriate confidence in dealing with inspectors. We organize front and back offices for inspection.
- During inspection we operate either as moderator, as note taker or as support based on the site request.
Inspections are never the same due to the character and behaviour of the inspectors and auditees. For this reason, we provide individual support to our customers.
During FDA inspections, the investigators verifies that the site ( including contract manufactures and contract laboratories ) operates according to the US FDA Regulations and pass successfully the inspection before to supply the US market.
Concerning EMA inspections, local Health Authorities ( member states of EC ) ensure that their inspectors assess according to Eudralex requirements and guidances.