Chemical Solutions Lab

Take Control of Your Analytical Instrument Qualification Program

What are PQ Kits? Â Â

USP <1058> and cGMP regulations require that analytical instruments undergo periodic Preventative Maintenance (PM) followed by a Performance Qualification (PQ). Furthermore, USP <1058> states that "Users should also be responsible for qualifying their instruments, because their training and expertise in the use of instruments make them the best-qualified groups to design the instrument test(s) and specifications necessary for successful AIQ".

Chemical Solutions has designed a line of traceable HPLC, UPLC, and UV-Vis spectrophotometer OQ/PQ kits that can serve as the foundation of your laboratory Analytical Instrument Qualification program. These kits have been designed by scientists with decades of experience in regulated laboratories, incorporating proven approaches into simple easy to use kits that can ensure regulatory compliance, while providing maximum information about your instrument performance.

The design philosophy of each of the kits is to provide a scientifically sound, complete solution to your instrument qualification needs. Each kit is comprised of a total package that you can integrate into your company SOPs, to achieve full compliance with all Regulatory requirements. Besides saving many thousands of dollars compared to have a Performance Qualification performed by factory service personnel, these kits also give you total control over your own AIQ program, both in terms of quality and timing.Â

The kit components vary according to the instrument type, however they all share a common approach in providing:

  • NIST-traceable, accurate analytical solutions produced in a modern laboratory under strict quality control. All solutions come with a Certificate of Analysis.
  • For the HPLC kits, a dedicated PQ column with a Certificate of Analysis.Â
  • Robust, proven test protocols to qualify all critical functions of the instrument rapidly and effectively.
  • Validated software to that generates a comprehensive summary report, ready for review.
  • Example SOP's that you can adapt into your own laboratory regulatory system.

 

Who uses the PQ Kits?

The various kits have been utilized by a wide range of leading pharmaceutical laboratories operating under cGMP/GLP regulations - The kits have been been field-proven over nearly nearly two decades of use to provide fast, convenient, comprehensive and most importantly compliant results that will meet the most stringent regulatory scrutiny.Â

The kits are ideally suited to smaller laboratories, maintaining only a few HPLCs or Spectrophotometers - The cost savings compared to using outside vendors will pay for the kit many times over just in the first year. The kits also "demystify" the AIQ process, and allow smaller laboratories to easily qualify their own instruments with full confidence, on a time schedule of their own choosing.

The kits are economical - The Validated Software is an integral part of the kits with no extra charges, with no onerous restrictions on usage. Current revisions are always available on our website for downloading to customers. Generous solution volumes are provided to perform multiple qualifications – for example as many as 20 qualifications can be performed with the HPLC kit. This allows for maximum flexibility, as opposed to single-use ampules. The clearly written instructions and example SOPs are matched to the validated software making execution of the test protocols simple and fast. The user can select the test protocols to be performed, allowing the qualification to be customized to the instrument configuration and qualification requirements.

In the HPLC kits, the same PQ test column is used for all of the various detector types. The PQ column "closes the loop" so the only variable remaining in the testing process becomes the instrument itself. The use of an actual column generates realistic test data under actual operating conditions, as opposed to test loops that do provide realistic conditions.  The PQ column is a one time purchase that will typically last for many years, since it is used only for dedicated PQ testing. It is stored in the PQ mobile phase, equilibrated and ready for use.

Other Uses

The PQ kits function as a universal "ruler" for comparison of intra- and inter-laboratory instrument performance. In addition to Performance Qualifications, the LC PQ kits can also serve as invaluable tools for:

  • Â Analyst Training
  • Method Transfer to Other Sites, allowing rapid comparison of instrument performance at the receiving laboratory
  • Instrument troubleshooting, where these known standards can be injected to rapidly isolate instrument vs. method or analyst problems

Why Buy?

Even larger corporations have increasingly realized the value of maintaining and qualifying their instrumentation using their own resources. For small to mid-sized labs, the greatest barrier to performing their own in-house qualifications is often the trepidation of setting up effective test protocols and writing the supporting SOP's. Â

The various PQ kits have been specifically designed to "demystify" the AIQ process, and to provide ready made, high quality materials and proven test procedures, so that you can quickly and confidently qualify your various instruments.Â

All our kits come with a full satisfaction guarantee. If you are dissatisfied with any of the various kits, you may return it for a full refund or cancellation of your invoice.

We provide comprehensive, unlimited technical support to help you through the process.

Try one today, and see how easy it is to take control of your Analytical Instrument Qualifications!