Dr. Wang Yu, Professor, Jiangsu Institute of Food & Drug control, China, talks to AZoM about the importance of raw material identification in the Chinese pharmaceutical industry and the benefits handheld Raman technology can offer to this process.
Could you please provide a brief introduction as to why Raman testing is important for raw material identification in the pharmaceutical industry?
The world is moving toward stricter regulations for the inspection of incoming raw materials. Mistakes within the industry could mean the difference between life and death. This presents a challenge, as using traditional testing methods usually involves inspecting about 10% of the raw materials. Raman testing is important because it allows the user to rapidly test and identify raw materials in an entirely non-destructive technique.
What regulations have been put in place to ensure the quality of these raw materials? Is Raman an accepted method for testing?
Regulations such as PIC/S require 100% inspection of incoming raw materials in addition to other regulatory authorities such as the USFDA, WHO-Geneva, Australian TGA, Spanish agency of medicines & health care products, ANVISA-Brazil, and IDA-Netherlands who have their own set of requirements etc.
In China, the cGMP published in 2011 stipulates that pharmaceutical manufacturers “Shall make corresponding operating instructions and take appropriate measures, such as checking or inspection to confirm EACH raw material within the packaging is correct.” That means raw materials inspection is also an important safety and quality factor in China.
Handheld Raman instruments also need to comply to 21CFR Part 11 for electronic records and signatures protocols and 21CRF Part 1040.10 for laser and laser system compliance.
Currently, Raman has already been approved as a method for testing according to the US Pharmacopeia chapter <1120>, the European Pharmacopeia Chapter 2.2.48, and the Guidelines for Raman Spectroscopy in the Pharmacopeia of the People’s Republic of China. Further updates are coming soon to solidify Raman as an accepted method for analysis.
What impact is this having on the industry?
100% incoming inspection of raw materials would have a significant impact in the inspection process, slowing production and increasing cost. These delays in producing the finished product would have a detrimental impact on reaching the people in need. Since the world is moving toward tighter regulations, the industry has to look into other methods to keep up with the regulations required without delays in production.
Why are traditional methods failing to meet the changing needs of this market?
With traditional methods like HPLC and other lab-based analytical techniques, raw materials are being held up in quarantine for long periods of time, and many companies have yet to even begin conducting 100% inspection. The time that would be lost if companies continued to utilize traditional techniques for 100% inspection is formidable.
What solutions are being offered to companies operating in this industry?
Solutions such as handheld Raman spectrometers with numerous sampling adaptors allow users to work with a variety of different types of raw materials, whether they are solids, liquids, powders, or slurries. Some Raman systems are programmed with two different algorithms, allowing users to not only identify, but also verify raw materials that may be contaminated or mislabeled. The uniqueness of Raman signatures for every individual raw material allows for a positive identification that can be trusted. Raman technology is a well-recognized method for compliance with the PIC/S GMP guide regarding 100% inspection of raw materials. Since Raman can scan directly through transparent packaging materials, it can be used to test raw materials as they are unloaded, speeding up the process drastically.
Is handheld Raman difficult to use by workers?
No, in fact some offer an easy-to-use user interface such as via intuitive touch-screen controls that allows users to quickly navigate and complete sampling procedures. With handheld Raman spectrometers, companies are able to get through hundreds of samples per day, allowing them to fulfil regulatory requirements of 100% identification testing of APIs.
For companies operating in this space, where does this fit into their process?
With handheld Raman, it is possible to complete 100% inspection as the materials are unloaded instead of having to take samples into the labs. Inspecting the raw material as it arrives speeds up the process from when the materials are received to when they are released into production with minimal sample handling.
How is this improving the workers’ safety?
Since Raman can test directly through transparent packaging materials, workers no longer need to conduct sampling that has the potential to expose them to dangerous chemicals and contaminate the very raw materials that we are testing. Each scan now only takes a few seconds for the operator to complete.
Are there any recent case studies that you can tell us about?
Two case studies where handheld Raman spectrometers helped with raw material identification and verification are at the companies Huahai and C&O Pharmaceutical Technology. These companies both needed a new way to inspect incoming raw material in a timely manner in order to keep up with the industry regulations. They turned to the NanoRam handheld Raman spectrometer from B&W Tek, which provides non-destructive identification and verification of raw materials as well as the option of batch scanning for large amounts of materials and features user friendly software for both technical and non-technical users to rapidly identify samples. With the new technology in house, these companies were able to work up to 100% inspection of their raw materials.
Where can our readers learn more?
Many instrument companies have their own website which contain details about available instruments, regulation and also applications. Here is an example from B&WTek, a handheld Raman instrument manufacturer.
About Wang Yu
Dr. Wang Yu, PhD., is a chief pharmacist and an adjunct professor at China Pharmaceutical University. He serves as a committee member on the Physical and Chemical Committee of the Chinese Pharmacopoeia Commission and is an expert evaluator for Chinese pharmaceutical drugs, health products, and cosmetics.
Dr. Wang completed his Ph.D. thesis between 2 visits in 1988 and 1989 to the University of Memphis, where he conducted research on Raman Spectroscopy.
Department Head and Associate Director at the Jiangsu Institute of Food and Drug Control. From 2006 to 2011, he completed several National Technological Support Projects relating to the 11th Five Year Plan and Jiangsu Science and Technology Fund projects, and participated in key research in collaboration with the SFDA and the Chinese Pharmacopoeia Commission regarding evaluative analysis and research on drug standards.
Dr. Wang has published over 130 articles based on his expertise in molecular spectroscopy as applied to pharmaceutical drug analysis and was the editor of the book “Pharmaceutical Drug Analysis.”
In 2011, Dr. Wang was awarded the “2011 Chinese Pharmaceutical Development Award – Food and Drug Analysis Technology”, the highest award in the pharmaceutical field.”
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