Compliance

Independent Audit & c-GMP & ASME-BPE Regulations Compliance Skills & Services

  • c-GMP Regulations Compliance Review, Audit, & CAPA and setting up the new GAPA approach
  • Sanitary Process Equipment, Clean Utilities & Pharmaceutical Systems Engineering & Design according to ASME-BPE-2009 standards
  • Facility/Equipment/Process Design
  • Environmental Monitoring & CPP specifications
  • Gowning/Aseptic Technique
  • Sterilization Technologies and procedures
  • Cleaning and Disinfection Technologies and procedures
  • Sanitary Process Design – Equipment Specification & Sizing according to current regulations, standards and laws: cGMP, FDA, Health Canada, EMA, ICH, ISO14644, ASME-BPE 2007, USP797, & USP, EuPh, JP, HSE, NFPA, ATEX, OSHA, SIMDUT
  • Process description, analysis and optimization
  • PFD, P&ID, Equipment sizing & Tie-In CAD Drawings
  • Facility & architectural design & requirements in compliance with ISO-14644 standard & related c-GMP guidelines.

Process Engineering Regulatory Skills & Services

  • URS, FRS, FDS & Technical specifications
  • Critical process parameters definition
  • Process engineering, equipment selection & integration
  • Process automation, SCADA, PLC, GAMP, 21 CFR part 11 & EMA annex 11
  • Critical control systems & instruments specification
  • Project & Process Risk Analysis Assessment (FMEA/AMDEC)
  • http://www.linkedin.com/pub/aziz-chraibi-phd-eng/b/a38/170

Pharma Bio Expert, your cGMP Regulation & Engineering Compliance Partner