Działamy w oparciu o:

Standardy jakości
Standardy jakości

Zobacz więcej

  • ISO 9001
  • ISO 27001
  • ISO 27012
  • ISO 20000
  • ISO 45000


Standardy procesowe i projektowe
Standardy procesowe i projektowe

Zobacz więcej

  • PMBok
  • Prince2
  • Lean
  • ITIL
  • Agile


U.S. Food and Drug Administration
U.S. Food and Drug Administration

Zobacz więcej

  • 21 CFR Part 11 – Electronic Records, Electronic Signatures (Pharmacy i Medical Device)
  • 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs; General (Pharmacy)
  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (Pharmacy)
  • 21 CFR Part 820 – Quality System Regulations (Medical Device)


European Medicines Agency
European Medicines Agency

Zobacz więcej

  • ISO 13485 – Medical Devices
  • ISO14644-1 Cleanroom Standards
  • European Comission Council Directive 93/42/EEC
  • EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines


Przepisy Ministerstwa Zdrowia
Przepisy Ministerstwa Zdrowia

Zobacz więcej

Rozporządzenie Ministra Zdrowia z dnia 9 listopada 2015 r. w sprawie wymagań Dobrej Praktyki Wytwarzania


Normy branżowe
Normy branżowe

Zobacz więcej

  • Quality Management Systems – Process Validation Guidance (GHTF/IMDRF)
  • ICH Guideline: VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2 (R1)
  • ICH Guideline: GOOD MANUFACTURING PRACTICE GUIDE FORACTIVE PHARMACEUTICAL INGREDIENTSQ7
  • ICH Guideline: PHARMACEUTICAL QUALITY SYSTEMQ10
  • PIC/S GMP GUIDE
  • PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS)
  • PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS)
  • PIC/S GMP GUIDE (ANNEXES)
  • ISPE Good Practice Guide: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
  • ISPE Good Practice Guide: A Risk-Based Approach to Electronic Records and Signatures
  • ISPE Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
  • ISPE Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)
  • ISPE Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)
  • ISPE Good Practice Guide: IT Infrastructure Control and Compliance
  • ISPE Good Practice Guide: Global Information Systems Control and Compliance
  • ISPE Good Practice Guide: Good Engineering Practice
  • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
  • ISPE Baseline Guide Volume 5: Commissioning and Qualification
  • ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
  • ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities (PACLAW)
  • ISPE Good Practice Guide: Process Gases
  • ISPE Baseline® Guide: Volume 4 – Water and Steam Systems (Second Edition)
  • ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Second Edition)

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