Guidelines and Standards Pharmtech Services Qualification and Validation Services Follow Our validation services assist our customers to meet industry requirements and guidelines established by government agencies (FDA, EU/EMA/EMEA, PMDA, TGA), industry organizations (WHO, ISO, ICH, ASTM, PDA, ISPE, CAP, USP), and industry guidelines (cGMP, cGLP, cGxP, cGDP, GAMP 5, 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211). Our equipment and software systems are validated and 21 CFR Part 11 compliant. Our ValSuite software has been audited for data integrity by third party companies. Qualification and Validation Service Reports, Protocols and SOPs Our team of expert validation engineers have a focus on the quality and accuracy of all documentation provided to you for your project. Pharmtech Services can be provided with report, protocol and SOP templates or we can draft documentation designed specifically for the project.
- 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…
Qualification Protocol Test Case Examples
Sterilisers
Walk In Stability Chamber
Deep Freezer
Dry Heat Sterilizers
Cold Rooms
Incubators
BOD Incubators
Referigerators
Deep Freezers
Lyophilisers
Ovens & Muffle Furnace
Final Reports
We understand how critical it is that all documentation meets current Good Documentation Practices (cGDP). Our validation experts know what is expected and how to accurately generate reports. Pharmtech’s validation report packages and summary reports are often leveraged during audits whether those are internal, customer, or the local governing body such as FDA or EMA.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 ValSuite validation and calibration software
- Standard Operating Procedures (SOP's)
Qualification Protocol Test Case Examples