Informa

28-29 September 2021


Industry Landscape


To ensure the safety of the U.S. drug supply, FDA has launched the availability of a guidance for industry, entitled“Control of N-Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of activepharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamineimpurities in pharmaceutical products. The guidance also describes root causes that may introduce nitrosamineimpurities.Regulatory agency such as Health Canada has also identified potential root causes and have asked all pharmacompanies to review their manufacturing processes and controls, take action to avoid nitrosamine impurities in allmedications, as necessary, test any products that could potentially contain nitrosamine impurities and report theirfindings to Health Canada. They have also asked to perform risk assessment for potential drugs which can formnitrosamine impurities and a ect patient safety. Similarly, ANVISA also published regulations which provides forinvestigation, control, and elimination of potentially carcinogenic nitrosamines in angiotensin II receptor antagonists.Companies are required to have appropriate control strategies to prevent or limit the presence of these impurities and,where necessary, to improve their manufacturing processes. The 2nd edition of Nitrosamine Impurities Forum willdiscuss on the current challenges & future perspective to deal with these impurities in drug substances & drugproducts.

During these 2-days of the conference challenges such as chemistry behind formation of these impurities in API &drug products (b)matching regulatory expectations to combat these impurities (c) understanding different rootcauses of these impurities (d) implementing 3-stage risk assessment process(e)selecting appropriate testingmethod/equipment will be discussed by industry stalwarts.

Glimpses of Previous Edition






Why this forum?

The second edition of Nitrosamines Impurities Forum will focus on the challenges to any molecule containing the nitroso functional group while discussing on the below:

Understanding current regulatory requirement to tackle with Nitrosamine Impurities concerns
How to calculate & derive on acceptable intake limit
Gain clarity on choosing correct analytical methods & tools to address these impurities
How nitrosamines are formed – Chemical mechanism behind this
How to stop condition reaction of forming nitrosamine impurity
How to restrict these impurities at the process or R&D stage

Speakers

Who Should Attend

Industries

Pharmaceuticals

Life sciences

Bio-Pharmaceuticals

API Manufacturers

Departments
Quality Assurance
Quality Control
R&D
Production & Manufacturing
Analytical
Packaging
Regulatory

Who should Partner?



Analytical equipment providers

  • GC-MS -MS
  • LC-MS-MS
  • Orbitrap
  • HPLC-MS
  • Nitrogen Chemiluminescence Detector
  • Small benchtop instruments

Industry experts assisting pharmaceutical industry through all the steps of investigation from risk assessment to analytical methods in order to confirm the levels of nitrosamine impurities in drug substances and drug products.

  • Chromatographic Columns
  • Filters
  • Chemical and AR-Grade Standards