Nitrosamine Round-table Discussion Series (No. 3)
The recall of Sartans (July-November 2018) and later of ranitidine (September 2019), nizatidine (January 2020) and metformin (May 2020) by FDA and other International regulatory agencies, owing to the presence of nitrosamines, raised serious global concerns about the quality and testing of APIs and pharmaceutical products. There was hurricane of updates and press announcements by regulatory bodies, leading to issue of multiple regulatory guidelines. Recently, NDSRIs and azido impurities in pharmaceuticals are also under focus.
Nitrosamines, NDSRIs and azido impurities are high potency mutagenic carcinogens, therefore, these are collectively classified as “Cohorts of Concern”. The regulatory agencies are in the process of listing these cohorts and to set up limits at which they need to be controlled. Also, there is emphasis on suitability of analytical techniques and methodologies and best practices for their quantitative evaluation. The attention to their presence has sparked mechanistic investigations to understand how these critical impurities end up in pharmaceuticals, whether through synthetic or degradation route, and best ways for risk assessment and their control.
To better understand the quality issues related to nitrosamines, NDSRIs and azido impurities in API and pharmaceutical products, to converse emerging solutions, and to collectively decide on the future sustainable course of action, Glostem has been holding high level Round-table Discussions of the stakeholders, involving regulatory authorities, bulk drug manufacturers, drug product manufacturers, pharmaceutical R&D organizations, private analytical laboratories, industry associations, select academic experts, as well as technology companies and solution providers. These Round-table Meetings are held in different cities so that knowledge and learning of Pharmaceutical and Regulatory Experts in this field can be shared to the maximum professionals working in API/Formulation industry and in testing laboratories.
The first meeting was held at Ahmedabad on December 6, 2019. This meeting was very well attended by the senior scientists from the Pharmaceutical Industry, and all the pertinent issues were meticulously addressed by the Government, Regulators, and Industry Experts.
The second meeting was held on February 15, 2020 at Hyderabad. This meeting was highly cherished by the stakeholder audience. The speakers/experts had affiliation to World Health Organization, Geneva; CDL, Kolkata; CDSCO, Zonal Office, Hyderabad; Pharmaceutical industries and Technology Companies.
The third meeting in the series, namely "Nitrosamines, NDSRIs & Azido Impurities in APIs and Pharmaceutical Products – Growing Concerns about Analysis, Control & Risk Assessment" is fixed for December 16, 2022, at Visakhapatnam, India. This Round-table Discussion will witness selected expert presentations addressing the issue, followed by moderated open discussions, wherein the participants will also get a chance to present their views and concerns. It is envisaged to invite regulators from USFDA/EMA and/or other regulatory bodies as well, either physically or virtually.
Points of Discussion
1. Most efficient technique(s) and method(s) of testing for nitrosamine, NDSRIs and azido impurities.
2. The best criterion to devise specification limits for regulatory acceptance and commercialization in light of evolving guidelines.
3. Mechanisms known till date that explain origin of these critical impurities in pharmaceuticals.
4. Risk assessment and mitigation strategies.
5. Excipient vendor declarations and re-assessment.
6. Importance of cleaning validation to avoid these cohorts of concern.
7. New updates till the day of meeting.
Who Should Attend
Chairman, President, Vice President, Managing Directors, CEO, CSO, Directors, Owners, Proprietors from Pharmaceutical industry (Research, API/Formulation Manufacturing, Analytical, Regulatory) and Testing laboratories as well as Professors/Scientists from Research Institutions who are experts in Pharmaceutical Impurity Profiling, Pharmaceutical Analysis, Stability testing as well as Organic Synthesis.
Type of Participation
Delegate: Attend the meeting only
Business Delegate: Attending and Networking during breaks as well as card exchange
Technology Expert: Attend the meeting, Present Technology Advancements in the field of Analysis and Impurity Profiling, Participate in Discussion (Selected Participants)
Participation of Technology Companies
Proposals are invited from the technology companies pioneering instruments and solutions related to analysis of pharmaceutical impurities and would like to present technical solutions to the current issue. The participation and presentation is limited to the Scientists/Application Specialists having specific experience related to pharmaceutical impurity profiling and will be by selection and subject to availability of presentation slots.
Ms. Farheen Zainab- Email: firstname.lastname@example.org or Call: 7696225050
Ms. Ankita Kanwar- Email: email@example.com or Call: 7696425050 or WhatsApp: 9041725050 for more information.
Former Deputy Head,
Partner & CEO,
QDOT Associates, India
Amoli Organics, India
Vice President, Head - R&D,
Metrochem API, India
Deputy Manager â€“ GC/GCMS Product Marketing,
Shimadzu Analytical (India) Pvt. Ltd, India
Application Support Manager,
SMS Pharmaceuticals Ltd, India
Ex-Professor & Head, Department of Pharmaceutical Analysis,
NIPER, Mohali, India