In the manufacture of medicines, it is common practice to purchase active pharmaceutical ingredients from third countries. Depending on the country of manufacture and the competent a registration authority, these active ingredients must meet certain quality standards, which are proven by a recognized audit.
Many pharmaceutical companies, therefore, have their foreign suppliers audited by an official institution or authority in order to be able to continue using their active ingredients on the local market. We prepare active ingredient manufacturers for GMP audits according to the standards of a PIC/S member or according to the principles of COFEPRIS.
Marcxell Medical advises and accompanies you to ensure the success of third-party audits. Based on our extensive experience with the various directives and licensing principles applicable in different markets, we support manufacturing sites in preparing for GMP audits.
Our pre-audit team assesses the site that is not yet certified and presents the optimization measures to be implemented. Our team contacts the responsible health authority and organizes the audit with the client and the supplier. We also support you in the organization of third-party administrative inspections and help you to comply with the audit plan. We are also present (in person) when the auditors visit the site. Take advantage of our expertise for the entire audit process to obtain the necessary approvals to market your solutions.
Accompaniment in the declaration of the audit to the health authorities of the target country such currently, we are planning to build the largest pharmaceutical plant and research laboratory in Africa. In order to produce vaccines and medicines on site.
Marcxell Medical is looking for a partnership with the government of Africa for the installation of the largest pharmaceutical factory (120.000m²) ever built in Africa with the collaboration of several world-renowned pharmaceutical companies. This plant will produce vaccines, medicines, and hospital products (equipment).