1. PIC/S GMP Guidelines
International trends in the quality assurance of drugs have changed dramatically in recent years. There is now a demand for overseas quality assurance measures to also be implemented in Japan. The increased need for international cooperation and information exchange with regard to GMP*1 brings a demand for more advanced business implementation systems.
Under these circumstances, Japan's Ministry of Health,Labour and Welfare applied for membership of PIC/S*2 in March 2012. As future GMP inspections will be based on the PIC/S GMP guidelines, analytical laboratories must comply with them as rapidly as possible.
The PIC/S GMP guidelines require acceptance testing on all raw materials. NIR spectroscopy and Raman spectroscopy, are attracting attention as inspection methods suitable for efficient on-site identification testing. Currently, the Japanese Pharmacopoeia (JP) prescribes NIR spectroscopy. On the other hand, the US Pharmacopoeia (USP) and European Pharmacopoeia (EP) prescribe Raman spectroscopy. Almost all major pharmaceutical corporations in countries other than Japan use Raman spectroscopy for the identification of received raw materials.
This is the acronym of Good Manufacturing Practice. GMP offers manufacturing control and quality control guidelines for drugs and quasi drugs. It is a standard enacted by government and other public organizations to ensure safety and reliability. The GMP Ministerial Ordinance prescribes validation standards related to the manufacture of drugs and quasi drugs and the conditions to be observed by manufacturers.
This is the acronym of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. As of January 2013, 41 countries were members, predominantly European countries. PIC/S is intended to provide an internationally harmonized standard and devise a quality assurance system for the continuous implementation of GMP compliance for pharmaceuticals. The PIC/S GMP Guidelines have been published as part of these activities.
2. Comparison of NIR Spectroscopy and Raman Spectroscopy
As near-infrared (NIR) spectroscopy and Raman spectroscopy obtain spectra based on molecular vibrations, they both permit qualitative analysis.
The term "near infrared" indicates light with wavelengths between 800nm and 2500nm (12500 to 4000cm-1 wavenumber). Absorption appearing in the near-infrared region involves overlaid harmonic and combination tones from normal vibrations and therefore produces wider and more complex peaks than does absorption in the mid-infrared region. Also, since the absorption intensity is lower than in the mid-infrared region, samples can be measured directly without being diluted with KBr or other agents.
Furthermore, cells made of glass or quartz, which are chemically stable and easy to use, can be used for NIR spectroscopy because they exhibit virtually no absorption in the near-infrared region. For details on NIR spectroscopy, refer to "Near-Infrared Region Measurement and Related Considerations" in FTIR TALK LETTER Vol. 9 and Vol. 10.
In this example of near-infrared analysis, we used the IntegratIR NIR integrating sphere shown in Fig. 1. Table 1 shows the measurement conditions. All sample types, including powder, pill, liquid, and paste samples, can be placed on the stage for measurement. Samples can also be measured when contained in a plastic bag or glass bottle.