Quality

QUALITY CONTROL

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).

  • HPLC/UV (Detection)
  • GC/FID
  • Head Space Sampler
  • Climatic Chambers
  • Photostability Chamber
  • UV, IR and FTIR Spectrophotometers
  • Polarimeter
  • Differential Scanning Colorimeter (DSC)
  • Equipment for physicochemical characterization of powders: Sieve Shaker Systems, Tap Density Tester, Microscopes and Malvern (PSD) System

QUALITY ASSURANCE

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.

REGULATORY AFFAIRS

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.).