Quality Management & GMP/GDP/GVP 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:
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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 | ||||
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GMP and GDP trainings | ||||
GMP and/or GDP audits of manufacturers of | ||||
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GDP audits of transport companies and distributors | ||||
Sale of ready-made GMP audit reports of active pharmaceutical ingredients (API) manufacturers | ||||
GVP system audits | ||||
Abbreviations:
- GMP – Good Manufacturing Practice
- GDP – Good Distribution Practice
- GVP – Good Vigilance Practice
- GxP – Good Practices (such as laboratory, clinical, etc.)