GAMP Services offers Qualification and Validation services for Facilities, Utilities, Systems, Equipment and Computerised Systems

Facility/HVAC validation – We offer Pharmaceutical and Medical Device facility/HVAC validation that will comply to PIC/S, EU EMA and US FDA regulations. We offer complete validation projects which include Reports, Protocols and SOPs and perform complete tests as per ISO 14644-1 & 2  

Equipment validation — Equipment Qualification and Validation Service includes Reports, Protocols and SOPs… 
Our team of expert validation engineers focuses on the quality and accuracy of all documentation provided for your project. GAMP services develop, design and execute report, protocol and SOP templates or documentation designed specifically for the project.

Qualification Protocol Test Case Examples

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ) or Continuous Qualification (CQ)
  • Power off / Power failure tests
  • Door Open tests
  • Temperature Distribution tests
  • Temperature Penetration tests
  • Alarm testing
  • Loaded and Empty Mappings
  • Instrument/equipment calibration
  • Shelf mapping, vacuum testing, biological indicator test, Bowie Dick test, vacuum leak test, conductivity tests, riboflavin removal testing, controlled rate mapping
  • And several more…

Final Reports
it is critical that all documentation meets current Good Documentation Practices (cGDP) as well as meets the expectation of all audits whether those are internal, customer, or the regulatory body such as FDA, EMA, MHRA, TGA etc  

We provide both hard and soft copies of the following as applicable:

  • Final summary report
  • Temperature mapping data, humidity mapping data and more.
  • Executed protocol (IQ/OQ/PQ/CQ/RQ as requested)
  • Test equipment and materials: Calibration certificates, pre and post verification data
  • Sensor location information: Diagrams, drawings, images
  • Employee training records
  • Audit trails generated by our validation and calibration software
  • Standard Operating Procedures (SOP’s)

we have the expertise and equipment to perform thermal validation of your Autoclave, Lyophiliser and Depyrogenation tunnel & CIP/SIP skid 

We have kaye validators with baths and sensors to perform thermal validation

Computer systems validation – we offer computer systems validation to US FDA 21 CFR Part 11 and TGA, EU and PIC/S PE 009 Annex 11 regulations.

Temperature mapping  – we have the expertise and equipment to perform temperature mapping of your warehouses, cold rooms and other temperature-controlled spaces.