Evolving Landscape on Control of Excipients Quality in Pharmaceutical Products
The quality and safety of pharmaceutical products are the top concerns of regulators. In recent years, regulatory agencies and pharmacopeia's have strengthened their position on preventing drug adulteration in both active pharmaceutical ingredients (API) and excipients by enacting new regulations and developing new documentary and reference standards.
- In May’23, USFDA released ‘Guidance for Industry’ mentioning about quantitative testing of DEG and EG levels for representative samples of each shipment of each lot before use in product manufacturing by gas chromatography (GC) instrument.
- Ministry of Commerce & Industry (INDIA) also released notification for amendment in Chapter-30 of Schedule 2 (Export Policy) related to export of Cough Syrups.
- WHO is also focusing on targeted quality testing of medicinal syrups imported to Rest of the World & Developing nations to confirm quality & compliance of syrups with respect to DEG & EG levels.
Join this webinar to hear IPC, USP and Agilent experts share their views on:
- Role of Pharmacopeia's in ensuring Quality of Pharmaceutical products and excipients
- Importance of Excipient Quality to Medicine Quality
- Understanding of high-risk excipients
- Advanced workflows to comply with latest regulatory and Pharmacopeial updates
Presenter: Dr. Tong (Jenny) Liu (Principal Scientist in Global Science and Standards - Excipients, United States Pharmacopeia)
Dr. Tong (Jenny) Liu is a Principal Scientist in Global Science and Standards — Excipients at the United States Pharmacopeial (USP). She is currently responsible for the development, update, and harmonization of excipient monographs and excipients-related general chapters under the work plan of the Pharmacopeial Discussion Group (PDG). PDG strives for the harmonization of compendial standards among European Pharmacopeia, Indian Pharmacopeia, Japanese Pharmacopeia, and the United States Pharmacopeia.
Dr. Liu has 20+ years of experience in analytical method development and validation for pharmaceutical products. She received her Ph.D. in chemistry from Boston University, Boston, USA. Supported by NIH Fellowship, she performed post-doctoral research in the Department of Chemical Biology, Ernest Mario School of Pharmacy in Rutgers University, New Jersey, USA.
Presenter: Mr. Arvind Kumar Sharma (Scientific Assistant, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare - Government of India)
With six years of experience as a Scientific Assistant at Indian Pharmacopoeia Commission, he has played a key role in the current development of Indian Pharmacopoeia Reference Substances (IPRS) and Impurity Reference Substances. He has been engaged in the preparation and updating of draft monographs for publishing in Indian Pharmacopoeia (IP). Additionally, he has played a major role in the development of the latest edition of the National Formulary of India 2021 and has been involved in work related to the Pharmacovigilance Programme of India (PvPI). He holds a a M. Pharmacy in Pharmacology from Sinhgad Institute of Pharmaceutical Sciences, Pune and a B. Pharmacy from the College of Pharmacy, IPS Academy Indore. He has authored several articles published in international journals and organized and represented IPC at various national and international conferences and workshops. He has also participated in joint inspections for registration of manufacturing units and testing laboratories.
Presenter: Mr. Praveen Arya (Application Engineer - GC/MS, Agilent Technologies)
Praveen Arya, Application Engineer at Agilent technologies, has a commitment and appreciation for Gas-phase residue applications. In 2005, Mr. Praveen Arya completed his M.Sc. in Food Technology . After post-graduation, he served as a Senior Analyst at SGS, Gurgaon- a commercial testing laboratory for 6 years and developed expertise in Residue analysis using sophisticated chromatographic instruments such as LCMS and GCMS. After that, in 2011, He joined Agilent Technologies as an Application Engineer where he supported country-wide GCMS customers for resolving application issues and method development. He has more than 18 years of experience in residue analysis in food and environmental samples using various high end chromatographic and spectrometric techniques (GC, GCMS, GCMS/MS, TDS, Headspace, Purge & trap etc.). His area of specialization includes new analytical method development and validation as per national and international guidelines.
