GMP&GDP service

  • Audit of existing quality system;

  • Quality system development and optimization;

  • Assistance with basic elements of quality system: change control, deviations, PQRs, management review, risk management, complains, CAPA system; Documentation management; outsourcing management; self-inspection system

  • Assistance with strategy of validations (process validation, cleaning validation & cross contamination etc.)

  • Assistance with risks assessment development, e.g. nitrosamine risks, heavy metals, excipients, cross contamination, process validation, reduced incoming quality control etc.

  • Development of QS documentation, e.g. Process descriptions, Standard operation procedures, templates, job descriptions, etc.

  • Quality/technical agreements, QP/QP agreements

  • Supply chains