Assessment of manufacturing place and audits of the manufacturer documentation

The assessment of technological, analytical documentation and manufacturers’ procedures quality: aims to verify whether the medicinal product or food supplement is manufactured and controlled according to appropriate procedures. Audits and assessments help to detect mistakes at an early stage and to perform correcting procedures.

To assist in this highly complex process SciencePharma can perform:

  • audits of procedures and documentation at active substance or medicinal product manufacturers sites referring to GMP and ISO requirements,
  • audits of food supplement manufacturing sites and documentation referring to GHP and HACCP requirements,
  • audits of cosmetics documentation and their manufacturing sites,
  • assessment of existing manufacturer quality system.

Additionally SciencePharma can serve a consultation within pharmaceutical companies due-diligence in the essential assessment of: utilized technologies, product portfolio, registration procedures and development perspectives.

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