DAVID TREW CONSULTING LIMITED
Version 9.1.1
+44 (0)1494 700693
This includes developing of the essential documents and qualification protocols, such as:
Qualification Plan
Identifying the activities required for instrument qualification
Design Qualification (DQ)
Design qualification is establishing a high degree of assurance that the instrument was procured with due consideration of the requirements of GMP, GLP or ISO 17025 as appropriate. This entails establishing appropriate user requirement specifications (URS), and converting these into functional requirement specifications (FRS) and operational specifications. My services also include vendor qualification
Risk Assessment (RA)
Assessing the quality, compliance and business consequences of and potential failure of any functionality of your instrument and required mitigation activities.
Installation Qualification (IQ)
The IQ protocol documents the instrument was delivered to your laboratory as ordered and your laboratory meets the requirements for the instrument. The installation qualification also documents the instrument has been installed correctly.
Operational Qualification (OQ)
The OQ protocol documents the laboratory instrument operates to established specifications in the installed environment. This includes developing the testing procedures as required.
Performance Qualification (PQ)
The PQ protocol documents the instrument performs to specifications appropriate for its routine use, and establishing the laboratory systems required to maintain the instruments in their qualified state. This can also include developing the test scripts.
Final Summary Report
Documenting all the qualification activities have been successfully carried out.
QUALIFICATION OF LABORATORY INSTRUMENTS
Laboratory instrumentation plays a key roll in the analytical testing carried out in a modern analytical laboratory. It is of fundamental importance that all laboratory instruments should be appropriately installed, commissioned, calibrated and maintained in order to assure that they will consistently deliver accurate and precise results which are both reliable and trustworthy.
In addition the Good Laboratory and Manufacturing Practice, and ISO 17025 requirements specify all instruments, equipment and measuring devices used for performing analysis are demonstrably suitable for their intended use and are maintained in a state of control. Also all laboratory instruments should be qualified, calibrated, serviced and maintained according to a written schedule.
Our instrument qualification services can help your laboratory with the commissioning of new instrumentation and with maintaining the qualified status of your existing instruments in accordance with regulatory and accreditation requirements.
Once your instruments have been qualified or if they are already qualified, we can manage their routine servicing, maintenance and qualification. This can include:
- Establishing and reviewing standard operating procedures (SOP) for instrument qualification
- Writing and executing validation master plans (VMP)
- Periodic instrument reviews in accordance with Good Automated Manufacturing Practice (GAMP) and International Society of Pharmaceutical Engineering (ISPE) recommendations
- Establishing change control procedures
- Review and approval of completed protocols
- Preparation for laboratory audits
All this will be achieved while ensuring minimal disruption of laboratory operations, and allowing you to focus on running your laboratory.