Pharmaceutical & Biotechnology

PHARMACEUTICAL/BIOTECHNOLOGY

The VQC Total Quality Solutions (TQS) have been used extensively and successfully in projects ranging from QA on building projects to cleanroom certification and analytical testing, in cGMP environments.

VALIDATIONS

  • Validation Master Plans, Cleaning validation, CIP/SIP validation.
  • DQ/IQ/OQ/PQ’s on utilities, systems and subsystems, process and method validation.
  TECHNICAL WRITING
  • Protocols, SOPs, VMPs, BPRs, training documents, change controls, studies, validation and technical reports, IRs, EIR’s, etc.
  CLEANROOM CERTIFICATION
  • According to ISO14644 and ISO14698, all classes, NEBB certified technicians.
  • Specialized testing; microbiological, particle counts, filter integrity and leak, airflow volume and velocity, air change rates, room containment leak, electrostatic discharge and dissipation, differential pressure, room recovery, airflow visualization, relative humidity and temperature, light intensity, noise level.
  • Environmental and surveillance monitoring
  • Mini-environment testing; biological safety cabinets, chemical fume hoods
  COMPRESSED AIR CERTIFICATION
  • According to ISO8573, all classes,
  • Specialized testing and personalized surveillance plans for particles, pressure dewpoint, oil vapors and organic solvents, oil aerosols, gaseous contaminants, microbiological including endotoxins
  AUDITING
  • Compliance, GMP, GDP, GLP, QMS, process, systems, suppliers, contractors, corporate policy
  • Preparation for regulatory inspections (FDA and EDQM)
  • Preparation for ISO9001 or ISO14001 certification
  COMMISSIONING
  • OATS and FATS on infrastructure and superstructure
  • All mechanical, electrical, LSS, Fire Protection and HVAC systems
  ENVIRONMENTAL MAINTENANCE
  • HVAC balancing and testing
  • Investigation of problem zones and contaminant ingress
  PROCESS OPTIMIZATION
  • Consultation
  • Gap elimination
  • Process controls
  • Technical solutions
  • Yield and product improvement
  • Utility optimization
  • Automation
  EHS
  • Consultation and design of comprehensive Environmental Health and Safety programs
  • Emergency response methodology
  • LSS and Fire Protection
  • MSDS and hazardous material handling (WHMIS)
 TRAINING
  • Utility Systems
  • Process Engineering
  • GMP
  • GDP
  • GLP
  • Cleanroom Behavior and gowning
  • ISO9001
  • ISO14001
  • Health and Safety
  • QMS
  • QE Principles
  ANALYTICAL TESTING
  • From particle counts to PCR VQC has Joint Ventures and Partnerships with virtually all University Test Laboratories as well as with most accredited specialized service laboratories in Israel as well as abroad (USA)
  •  VQC uses mobile equipment labs where site required and maintains its own instrument lab on its premises