Check list to faster qualification
The slow pace of instrument qualification can often hold up important work. Joe Gecsey, application manager at Hach Ultra, US, explains how to speed up the process
Many of the instruments employed in the laboratory and on the production floor are self-contained electronic analysers that are more intelligent than their predecessors, being self-contained with embedded intelligence and computational power. With reasonable preparation and good documentation from the manufacturer, instruments such as airborne particle counters and other portable analysers can be fully qualified with a day’s effort or less. The key lies in those two phrases: “reasonable preparation” and “good documentation from the manufacturer”.
The latest endeavour to formalise and streamline the process of Analytical Instrument Qualification is from the United States Pharmacopoeial Convention. Generally known as USP <1058> Analytical Instrument Qualification, it is not yet a released document, but it follows closely published industry discussions on the use of the 4Qs: DQ, IQ, OQ and PQ.1 This article addresses some of the practical considerations of preparing for and expediting the qualification effort for these types of analytical instruments.
Qualification efforts must start with the purpose and characteristics of the instrument and its intended use; generally this is stated in some form of a User Requirement Specification (URS). Some requirements will be outside the basic realm of the scientific use of the instrument; for example, that the instrument as installed will be compliant with the US FDA 21CFR Part 11 standard, “Electronic Records and Electronic Signatures”. In clearly stating these various needs in the URS, the foundation is laid for establishing the test cases for the qualification effort.
But qualification execution is often delayed by oversight of simple items in preparation for the exercise of the equip-ment in the IQ and OQ, and part of the partnership between the supplier and the user will be to clearly define the tasks and responsibilities weeks before the on-site qualification takes place. From practical experience, these are some of the basic tasks that can be accomplished beforehand to smooth the process and acheive complete qualification sign-off.
1. Gathering support documents:
- a. User Requirement Specification (URS): what is needed
- b. Purchase Order: what was ordered
- c. Shipping documents: what was received
- d. Company protocols on security: preferred password style, expiry dates etc.
- e. Standard Operating Procedures: how the instrument is to be used at this facility
- f. Company protocols on Change Control
- g. Accepted IQ/OQ procedures (from manufacturer or other source)
- h. System performance verification tests and their frequency (daily, weekly, etc)
- i. Creation of “qualification binder” of static documents
- j. Creation of dynamic document binder kept with instrument:
- i. Will contain copy of OQ documents
- ii. Will contain copy of results of ongoing system verification tests.
- a. Location and method of storing documentation related to this instrument
- b. Will an on-site re-calibration of the instrument be required?
- c. Frequency of scheduled re-qualification
- d. Conditions of unscheduled requalifi-cation (firmware upgrade, repair, etc.)
- e. Responsible person(s) named to conduct or assist in the qualification
- f. Responsible person(s) to review and approve qualification
- g. List of authorised operators and their access levels:
- i. Instrument operation only
- ii. Change of instrument configuration
- iii. System administrator, etc.
- h. Responsible persons for change control
- i. Contact person at company to whom vendor can report system updates, etc
- j. Where IQ/OQ process can be accomplished.
Within the proposed USP <1058> recommendations, portable, intelligent instruments such as airborne particle counters will typically fall into an intermediate category regarding the complexity of qualification. USP <1058> designates this as “Group B”, but the qualification effort is still needed. Yet the physical testing for IQ and OQ can be accomplished in a day’s period for each instrument when the required documentation and protocols have been gathered and the IQ/OQ documentation has been mutually agreed beforehand.