Navigating the Complexities of Pharmaceutical Manufacturing Regulations
While regulatory enforcement agencies around the world have increased scrutiny on quality assurance/quality control programs, pharmaceutical manufacturers are increasingly looking for ways to lean out the manufacturing process without compromise to product quality. This push and pull conundrum has manufacturers seeking guidance on global industry regulations while searching for alternatives to legacy quality practices. With the expanding supply chain and the onset of globalization, it is now more important than ever to adjust quality programs to improve efficiency but remain keen on effectiveness for the continued promise of product quality and patient safety.
Handheld Raman technology is currently being implemented by global pharmaceutical manufacturers and regulatory agencies around the world providing an effective alternative approach to increased testing and heightened quality programs. This pharma webinar will introduce unconventional approaches to enhance quality programs with the use of modern handheld technology.
Michael A. Dotlich (Research Scientist, Eli Lilly and Company)
USP Spectral Library – Development Validation and Implementation
The USP is pursuing the development and implementation of an authoritative and comprehensive food and drug informatics database, known as the USP Spectral Library. Once fully developed and operational, the library will be a valuable tool in the development of quality standards using spectral images as well as for material identification and rapid, non-invasive screening of counterfeit and substandard foods and drugs.
A precursor to the final development and implementation of the Spectral Library includes a pilot study that has been designed to focus on materials and technologies with a high probability of success, e.g., Raman, FTIR and NIR. The pilot has been designed to assess both the spectroscopic technology and the database infrastructure. As part of the first pilot, materials were tested by handheld Raman and portable FTIR. Data evaluation will be used to demonstrate reproducibility and repeatability across material suppliers, collaborative testing laboratories, analytical instruments and analysts.
Bei Ma (International Business Development Manager, U.S. Pharmacopeial Convention)
The USP Spectral Library Project is a new initiative to develop an authoritative and comprehensive collection of spectral information on food and drug quality. With potential applications in quality standards development, rapid screening in the field for counterfeit and substandard foods and medicines based on portable analytical technology, and the identification of raw materials as well as finished products, the USP Spectral Library can be a useful tool for regulatory authorities, law enforcement agencies, hospitals, pharmacies, manufacturers, and distributors around the world.
USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide.
USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP standards are developed and revised by more than 900 volunteer experts, including international participants, who work with USP under strict conflict-of-interest rules.
Dr. Claire Dentinger (Senior Applications Scientist, Rigaku Raman Technologies)
Extend the range of RMID tools – R&D to Formulations
Claire Dentinger is a Senior Applications Scientist with Rigaku Raman Technologies. She has 15 plus years’ experience with optical spectroscopies including Raman, Fourier Transform Infrared, fluorescence, ellipsomerty and surface plasmon resonance. She also has significant experience in the area of biotechnology and surface chemistry. She received her PhD from the University of Wisconsin in Analytical Chemistry and her BA from St Olaf College in Chemistry.
Pharmaceutical companies no longer wonder ‘if’ they should implement handheld Raman instrumentation, but instead are determining which Raman instrument is best-suited for their unique production environment. Instrument selection factors related to improving workflow, efficiency and extending the range of inspections that can be performed utilizing handheld Raman will be presented.
Supported by Rigaku Raman Technologies
Rigaku Analytical Devices is leading with innovation to pioneer a portfolio of handheld spectroscopic analysers for use in the protection of public health and safety, aid in the advancement of scientific and academic study, enable the recycle and reuse of metal alloys, and ensure quality of key metal alloy components in mission-critical industries. Their products utilise integrated software that combines an open architecture platform with user defined settings, delivering unparalleled accuracy and extensive application support, empowering their customers to achieve rapid lab-quality results any time, any place.
Find out more: www.rigaku.com