Solutions in spectroscopy encompass a wide range of options. Within your laboratory, FTIR, NIR, Raman, or UV-Vis spectroscopies may be employed, with each of these instruments serving a distinct purpose. Spectroscopic instruments may be utilized to provide comprehensive analyses of materials or for the purpose of product testing. In either scenario, a meticulous approach to compliance in daily operations is imperative. Upholding the utmost standards is crucial in order to realize the full value of spectroscopy solutions.
Core Functions of Spectroscopy Instruments
The Spectrum of Analyses
The application of spectroscopic solutions can be broadly bucketed into one of three areas:
- Raw materials qualifications
- In-process checks
- Finished goods qualifications and QCs
Each type of spectrometer offers a unique benefit, but as a group they are designed to investigate three quintessential unknowns: identity, purity, and quantity. Fourier Transform infrared (FTIR) spectroscopy offers notable performance in all three areas. It is a mainstay in raw material identification. With the inclusion of quality-check algorithms like QCheck, FTIR also offers valuable purity verification. (QCheck is a specialized software tool that provides a comparative analysis between the material in question and an established standard.) And by employing calibration techniques, FTIR spectroscopy solutions are also increasingly indispensable for ascertaining material volumes. This trifecta of identity, purity, and quantity cements FTIR’s integral place in the ever-evolving field of spectroscopy instrumentation.
Mastering Compliance in Spectroscopy Instrumentation
1. FTIR Compliance Components
Ensuring FTIR results are credible requires careful compliance. This comprises four components:
- System qualification
- 21 CFR Part 11 tools
- Operator training
- Validation
2. Delving into System Qualifications
For new instruments, system qualification branches into four crucial aspects:
- Design Qualification (DQ): Verifies the instrument’s design attributes are acceptable.
- Installation Qualification (IQ): Ensures instrument functionality aligns with factory specifications post-installation.
- Operational Qualification (OQ): Confirms adherence to the intended use specifications of the instrument.
- Performance Qualification: Distinctly defines an instrument’s intended performance for specific applications.
3. The Imperative of Operational Qualifications & Pharmacopoeia Tests
With varied protocols in the pharmaceutical world—be it USP, European, Japanese, or Chinese pharmacopoeias—compliance with established benchmarks is essential. The qualification tests like those listed above, automated within the software, adhere to NIST standards, with the polystyrene standard in FTIR being especially noteworthy.
Furthermore, different modules must meet distinct standard requirements. This multipart design offers a comprehensive approach to ensuring optimal results.
4. Software’s Role in Spectroscopy Instrumentation
Software is a central aspect of spectroscopic performance. The integrated software in modern instrumentation undergoes meticulous IQ and OQ processes, underlining the amalgamation of hardware prowess and software precision. Software that is specifically 21 CFR part 11 compliant and GMP/GLP compliant is a key feature.
Elevating Compliance in Spectroscopy Solutions
The demand for rigorous compliance is unavoidable in today’s intricate landscape of spectroscopy. Users should embrace the highest compliance standards to elevate the trustworthiness of scientific analysis. If you would like to learn more about compliance with pharma regulations, watch this webinar on the subject here.
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