AuditGMP Pharma follows the inspection requirements of ISO 17.000:2004, for the Conformity Evaluation of the Regulation of the Good Manufacturing Practices, GMP, assuring the basic principles of Evaluation: INDEPENDENCE Exclusive dedication to audits in all their aspects. INTEGRITY and CONFIDENCIALITY By selected personnel among well-known professionals in the pharmaceutical industry and an absolute respect for the Confidentiality towards the client and the audited. IMPARCIALITY Company not linked to any other activity. TECHNICAL COMPETENCE Through a group of experts of recognised experience and competence in the pharmaceutical industrial field.
AUDIT GMP Pharma has got ENAC’s accreditation, the National Accreditation Entity, as Inspection Entity of the requirements of the “Good Manufacturing Practices in the European Union for the manufacture of human use and veterinary use medicines” to the manufacturers of active substances and pharmaceutical excipients, according to Directives 2001/83/EC and their corrections, 2004/27/CE and 2011/62/EU which cover the GMP for pharmaceutical raw materials. DIRECTIVE 2003/94/CEE of the Commission which covers the GMP of medicines of human use and the medicines in research for human use. DIRECTIVE 91/412/CEE for GMP of veterinarian medicines.