Pharmaceutical


WHO guidelines on Good Manufacturing Practices (GMP),
ISO Certification & Quality Management System (QMS)

QMS combining ISO and GMP

Within the pharmaceutical, medical device industries, Hospitals and hospital pharmacies, government regulations require all controlled environments to be tested and certified per ISO 14644 from the International Organization for Standardization (usually called the ISO). Air Quality Control qualified technicians can certify, to any ISO Class required, all controlled environments.

Air Quality Control has implemented Quality Management System (QMS) as part of their service, overall there was a clear tendency with the regulations being enforced upon Herbal Medicine manufactures, with this in mind Air Quality Control expanded their current scope of work to integrate Quality Management System (QMS) into there profile. We provide our clients with a Project Management and Project life cycle.

  • WHO guidelines on Good Manufacturing Practice (GMP) for Herbal Medicines
  • Quality Management System (QMS)
  • Good Manufacturing Practices (GMP)
  • Validation of cleanrooms to ISO 14644, EU GMP, WHO and other standards or to clients in-house requirements
  • Validation of Laminar Flow Benches to ISO 14644
  • Validation of Safety Cabinets to BS EN 12469:2000
  • Testing of Fume Cupboards to COSHH & BS7258:1994, BS7989:2001
  • Ultraclean and Orthopedic Theatre commissioned and validated ISO14644 or to clients in-house requirements
  • Temperature and humidity mapping

Each clean room is different. Our fully trained technicians have worked on virtually every type of clean room and HEPA filtration system now in use. Whether it’s a clean room supplied with individual fan filter units with HEPA filters, or a space with an independent air-handling unit, our technicians knows it inside and out. When problems occur and compliance with ISO/EU requirements is threatened, Air Quality Control team can knowledgeably assess the problem and quickly resolve your issue. Results: less downtime and more productivity for manufacturing and processing.


GMP Consulting & Services

Facilities require QMS, cGMP & ISO


Quality Management System:

  • Facilities and equipment system
  • Production system
  • Packaging and labeling system
  • Laboratory controls system
  • Materials system
  • Documentation

Air Cleanliness Comprises:

  • Microbial Contamination
  • Particulate Contamination

Airborne Particle Counts:

  • Airborne Particle Counting in Different Occupancy States
  • Measure of Particle Concentrations
  • Test should be carried in accordance with International Standards ISO, GMP, EU GMP
  • Documentation SOP & Protocols

How Often to Testing should be carried out:

  • Testing should be carried out accordance with International Standards ISO, GMP, EU GMP
  • Test when newly installed ISO14644-1:2001, SANS 14644-1:2003 Edition 1
  • Not more than 12 months between testing depending on ISO rating
  • Test after every change to the system
  • Test after filter change
  • Documentation SOP & Protocols

Filter Integrity Testing:

  • Establish the Principles of DOP Filter Testing
  • Ensure all Hepa specifications are available including DOP Certificates from Hepa manufacture.
  • Documentation SOP & Protocols

Airborne & Water Bacterial Monitoring:

  • Establish existing procedure of bacterial testing
  • Sampling of air borne bacteria
  • Sampling of water borne for Legionella and Potable water testing
  • Work with microbiologist to ensure protocols and procedures are
    being followed or establish protocols and procedures for client.

Measurement of Air Quantities and Pressure Differences:

  • Testing of Air Quantities
  • Differential Pressure Tests
  • Documentation SOP & Protocols

Microbiological Safety Cabinet Testing – Laminar Flow and Biohazard Benches:

  • Testing of Air Quantities
  • Particle Count classification
  • Test according to European Standard EN12469, BS5726, AS1807/AS2252/AS2647, JIS k3800:2000 and NSF49:2008
  • Documentation SOP & Protocols

Fume Hood Testing:

  • Measurement of Air flow
  • Visualisation air flow patterns
  • Documentation SOP & Protocols

Consulting in Cleanroom Fundamentals of Design, Testing,
Operation & Quality Management System:

  • Cleanroom Construction and Clean-build
  • Project Management
  • Testing should be carried out accordance with International Standards ISO, GMP, EU GMP
  • Operating a Cleanroom: Managing the Risk from Contamination
  • Implementation of SANS 1841 ( E mark accreditation)
  • Implementation of ISO 22716 ( GMP Standard for Cosmetics)
  • Re-organization of Quality circles, to incorporate outcome based solutions
  • ISO 14000 upgrade project initiation
  • Management of the SHE program to achieve a NOSA 5 star certification
  • Integration of ISO 9001, ISO 14000, and BS18000 project initiation
  • Development of Documentations

Training:

  • Cleanroom Testing and Certification Board International
  • Airflow Measurement and Testing Theory and Practical
  • Principles of Filter Testing
  • Microbiological Safety Cabinet Testing
  • Principles and Application of Particle Counting
  • ISO22000, ISO17026, ISO13485, GMP & GWP, Qualification of Facilities & Processes,
    Quality Awareness and Food Hygiene Practices