
Zobacz więcej
- ISO 9001
- ISO 27001
- ISO 27012
- ISO 20000
- ISO 45000

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- PMBok
- Prince2
- Lean
- ITIL
- Agile

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- 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)

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

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

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)