Reduce the burden of compliance while still protecting regulatory status in a GxP environment for Analytical Instrument Qualification

How can companies reduce the burden of compliance while still protecting regulatory status in a GxP environment for Analytical Instrumentation? This can be accomplished by creating a compliance program that addresses instruments ranging from complex Liquid Chromatography (LC) equipment to simple Vortex Mixers using guidance from USP <1058>.

aiq

Early in 2014 ICQ led the remediation effort to develop a program for Analytical Instrument Qualification (AIQ) at one of our client sites following guidance set by USP (United States Pharmacopeia) <1058>. Standard Operating Procedures as well as approved templates were developed for each step in the process, starting with bringing equipment into the facility, classifying every piece, all the way to release of equipment for GMP use. All procedures were customized to the client needs while still following guidance from USP <1058>. This program ensures the client is compliant in AIQ efforts as well as provides a well-defined, streamlined approach for Analytical Instrument Qualification.

Throughout implantation of the new program, ICQ has continued to “customize” the AIQ program, with all applicable Standard Operating Procedures, to the client’s needs while continuing to follow the guidance set by USP <1058>.

This program provides methodology to determine the degree of qualification required for analytical instruments and equipment following a risk-based approach to assess the level of qualification required. USP <1058> defines categories of equipment as Group A, Group B or Group C, where each group has more deliverables based upon complexity of equipment. In addition to the groups defined by USP <1058>, groups can be further broken up using a well-defined, risk-based approach. For example, for one client the Group B class was further broken up to include a group called Group B-Calibration Only, where certain pieces of equipment may only need to be calibrated rather than have an IOQ performed. Definitions of the groups are defined below.

  • Group A: Standard equipment with no measurement capability or requirement for calibration, where the manufacturer’s specification of basic functionality is accepted as user requirements
  • Group B-Cal Only: Standard equipment and instruments providing measured values
  • Group B: Standard Equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration
  • Group C: Instruments and computerized analytical systems, where user requirements for functionality, operation and performance limits are specific for the analytical application.

Examples of equipment that may fall into the defined groups as well as deliverables for the different equipment groups can be seen below.

Group Examples of Equipment Deliverables
A Nitrogen Evaporators, Hotplates, Vortex Mixers
  1. Equipment Classification
B-CAL Thermometers, Timers, Pipettes, Gauges
  1. Equipment Classification
  2. Group B-Cal Qualification Form
B Air Samplers, Particle Counters
  1. Equipment Classification
  2. URS
  3. Computerized System Assessment
  4. DQ
  5. IOQ
  6. Equipment Release
C HPLC’s, GC’s, Spectrophotometers, TOC Analyzers, Plate Readers
  1. Equipment Classification
  2. URS
  3. Computerized System Assessment
  4. DQ
  5. IOQ
  6. PQ
  7. Equipment Release

It is important to note that this program only applies to Commercial off the Shelf (COTS) pieces of equipment, and does not include custom designed equipment. Through use of the program, COTS equipment can be assessed for risk based on complexity and the qualification efforts can be commensurate with such complexity. This allows the business to save time and money as well as provide resources to complete deliverables for more complex systems.

 Written By: Robert Farley, ICQ Consultants Corp. Managing Consultant

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