Quality Management & GMP/GDP/GVP Audits

Quality Management & QMP Audits
Quality Management services & GMP/GxP Audits for pharmaceutical companies
Inpharmatis provides a full range of Quality Management services to support pharmaceutical companies in EU, EAEU and CIS countries
Quality Management & GMP/GDP/GxP Audits

Inpharmatis consulting services include the development, evaluation, and optimisation of client company Quality Systems. We also conduct audits of manufacturers of medicines, active pharmaceutical ingredients (APIs), excipients, and packaging materials. As well, we audit transportation companies and distributors to ensure compliance with GMP, GDP, GVP, or GxP requirements.

Inpharmatis services aim to ensure compliance with the relevant legislation in Europe, CIS, and EAEU: Uzbekistan, Kazakhstan, Russia, Belarus, Kyrgyzstan, Moldova, Armenia, Georgia, Tajikistan, Turkmenistan, Ukraine, Azerbaijan, Mongolia, Latvia, and other countries within these regions. 

Total Quality Management (TQM) services include: 
Quality Management System (QMS) development/audit and improvement 
GMP and GDP consulting 
Quality Assurance (QA) service 
Qualified Person (QP) service
QMS documentation development
Preparation and organisation of official EU/EAEU GMP/GDP inspections, as well as support during and after the inspection, including CAPA management
  • Preparation and conduction of the manufacturing site/company pre-audit in accordance with GMP/GDP requirements
  • Monitoring the resolution of observations identified during the pre-audit, ensuring that corrective and preventive actions (CAPA) are implemented and completed for a successful official inspection
  • Application for GMP/GDP certification and communication with Regulatory Authorities
  • Organisation of GMP/GDP inspections (communication with Regulatory Authorities, when necessary, during the planning and execution of the inspections, as well as providing full support and consultations throughout the inspection process)
  • Consulting support in the preparation and closure of the CAPA plan after an inspection, including organizing its submission to regulatory authorities
GMP and GDP trainings
GMP and/or GDP audits of manufacturers of
  • Finished dosage forms
  • Semi-finished dosage forms
  • Active pharmaceutical ingredients (APIs)
  • Raw materials /excipients
  • Packaging materials
GDP audits of transport companies and distributors
Sale of ready-made GMP audit reports of active pharmaceutical ingredients (API) manufacturers
GVP system audits
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Inpharmatis assists Your company in complying with GMP, GDP, and other regulations to ensure the safe manufacturing of Your products!

 

Abbreviations:

  • GMP – Good Manufacturing Practice
  • GDP – Good Distribution Practice
  • GVP – Good Vigilance Practice
  • GxP – Good Practices (such as laboratory, clinical, etc.)