It is responsible for controlling that raw materials, intermediates, ﬁnal products, auxiliary materials and packaging in compliance with current GMP.
Analytical methods and speciﬁcations are both developed and validated by an experienced professional team.
Reference Standards are also characterized and supplied.
Stability studies, in-process controls and equipment cleaning validation are performed in this Division.
The Impurity Proﬁle of each API developed at Maprimed is carefully studied (including Residual Solvents, Genotoxic Impurities, Residual Catalysis and Polymorphism).
All these studies are carried out employing advanced techniques to conform to international requirements (ICH and Pharmacopoeias).
The Validation Master Plan includes Process and Cleaning Validation, which is performed in accordance with FDA, ICH and TGA regulations.
Both internal and external inspections are regularly carried out.
Inspection from Health Authorities and customers are periodically received.
CTDs, DMFs and supporting documents are prepared and provided by our internal staff.
All documentation related to drugs registration (CTDs, CEPs, Expert Reports, Objection Letters, Agreements, etc.) is issued according to each customer and country’s requirements following the current registration procedures (MRC, DCP, etc.).