Topics tagged Manufacturing

Topic	Replies	Views	Activity
Control limit of Nitrosamines and N-nitroso compounds Limits of Nitrosamines Manufacturing , risk-assessment , Drug_Substance_APIs , NDSRI	2	285	July 8, 2024
Risk analysis of nitrosamine impurities in liquid products (essences and flavors) Risk Assessment Strategy / Tools & Technology Manufacturing , Excipients	3	602	June 28, 2024
Discussion on Cleaning Validation Requirements for Nitrosamines New Scientific Knowledge & Development Manufacturing , NDSRI	3	694	June 24, 2024
MEGLUMINE (Methylglucamine) Limits of Nitrosamines Manufacturing , Drug_Substance_APIs , Excipients	18	2306	June 19, 2024
Update: EFPIA workflows for Quality Risk management Jun 2024 v03 Guidance, Documents, Resources Packaging , Manufacturing , Drug_Substance_APIs , Excipients , NDSRI	2	385	June 4, 2024
Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs Events / Workshops / Webinars Live-Conversations , NDSRI , Drug_Substance_APIs , Manufacturing , Excipients	21	1356	May 22, 2024
AI Limit for Nitroso Nebivolol Limits of Nitrosamines FDA , Drug_Substance_APIs , Storage_Stability , Manufacturing , Live-Conversations	11	2414	April 3, 2024
N- nitroso Nitazoxanide Limits of Nitrosamines Drug_Substance_APIs , Manufacturing , NDSRI	1	410	February 8, 2024
Nitrosamine Impurities in Topical Drug Product Limits of Nitrosamines Manufacturing , NDSRI	3	575	February 3, 2024
10º encontro Farmacopeia Brasileira Events / Workshops / Webinars NDSRI , Manufacturing , Drug_Substance_APIs	0	467	November 30, 2023
Nitrosamines risk assessments for Topical herbal extracts Risk Assessment Strategy / Tools & Technology Manufacturing	1	481	September 20, 2023
Apixaban Drug Substance-Related Impurities (NDSRIs) Root Causes Manufacturing , NDSRI , Excipients , Drug_Substance_APIs	3	1280	September 15, 2023
Total impurities limit if more than one nitrosamine impurities are observed in product Limits of Nitrosamines Manufacturing , NDSRI , Drug_Substance_APIs , FDA , Live-Conversations	4	624	August 14, 2023
The Nitrosamine “Saga” Guidance, Documents, Resources Manufacturing , Drug_Substance_APIs	3	1587	July 29, 2023
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities Events / Workshops / Webinars Excipients , FDA , NDSRI , Drug_Substance_APIs , Manufacturing	11	3187	July 27, 2023
NDSRIs: Atualizações e Desafios Guidance, Documents, Resources Manufacturing , Drug_Substance_APIs , NDSRI	0	434	July 24, 2023
N-nitroso Des-methyl Dapoxetine Limits of Nitrosamines FDA , Manufacturing , Drug_Substance_APIs	12	1111	May 31, 2023
Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis Solvent/Water Manufacturing , Drug_Substance_APIs	2	1099	May 23, 2023
Carry over limits for Niitrsoamines New Scientific Knowledge & Development Manufacturing , Drug_Substance_APIs	2	692	February 12, 2023
Nitrosamine risks that may arise from the filters Manufacturing Processes Manufacturing	2	743	January 4, 2023
Cleaning Validations Criteria Limits of Nitrosamines Manufacturing	1	1556	December 5, 2022
2 days seminar on nitrosamine and extractable & leachable Events / Workshops / Webinars Packaging , Drug_Substance_APIs , Manufacturing	0	531	November 21, 2022
Nitrite / Nitrosamine levels in Excipients Guidance, Documents, Resources Manufacturing , Excipients	0	480	November 17, 2022
Azithromycin - presence of N-Nitrosamines Nitrosamines in the News Manufacturing	8	808	March 3, 2022
Mutagenic Impurities Strategies for Identification and Control - now published Guidance, Documents, Resources Excipients , Packaging , Drug_Substance_APIs , Solvent_Water , Manufacturing	9	455	March 2, 2022