Guidance, Documents, Resources

Topic	Replies	Views	Activity
👨‍💻 Dashboard Containing Published AI Limits NDSRI , AI , featured Are you looking for a central place for published AI limits? I have created a dashboard containing Acceptable Intake Limits from FDA, Health Canada and EMA. I am looking for folks that are interest into contributing to …	25	2242	July 24, 2024
About the Guidance, Documents, Resources category	0	454	April 14, 2021
EMA/CHMP Concept paper on the revision of the guideline on the chemistry of active substances	3	415	July 26, 2024
Development and Manufacture of Oligonucleotides + Nitrosamines	0	118	July 24, 2024
Methylene Blue NDSRI	5	239	July 24, 2024
🇪🇺 EMA/409815/2020 Rev.21 (19-Jul-24) EMA	1	526	July 22, 2024
USP - CPCA Nitrosamines Case Study NDSRI	5	953	July 10, 2024
ICH M7 & Nitrosamines Impurities -Updates ICH-M7	7	1470	July 1, 2024
AI for NDSRI by Brazil regulatory NDSRI	4	551	June 28, 2024
Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity? Drug_Substance_APIs , NDSRI	6	297	June 27, 2024
ICH M7 plans to harmonize AI limits for Nitrosamines	1	234	June 13, 2024
Nitrosamines in food raise a health concern (EFSA)	7	977	June 11, 2024
Update: EFPIA workflows for Quality Risk management Jun 2024 v03 Packaging , Manufacturing , Drug_Substance_APIs , Excipients , NDSRI	2	384	June 4, 2024
🇰🇷 Case study on the Occurrence of Impurities in Pharmaceuticals (Focusing on NDMA Cases) risk-assessment	0	210	May 31, 2024
🇲🇽 Coming July Mexico Nitrosamines Guideline	2	271	May 30, 2024
Justify the presence of amine in the API chemical structure	3	189	May 29, 2024
FDA releases FY23 GDUFA Science and Research Report	0	231	May 24, 2024
🇪🇺 EDQM - top 10 deficiencies observed in new CEP applications risk-assessment	0	825	March 14, 2024
An Organic Guide to N-Nitrosamines: Structure, Reactivity, and Role as Contaminants	1	485	May 13, 2024
APIC NA Risk Assessment Template Drug_Substance_APIs , NDSRI	5	2671	May 11, 2024
Autonomous CPCA Web-based calculator FREE Drug_Substance_APIs , NDSRI	28	4480	May 2, 2024
WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products	3	884	April 24, 2024
🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments NDSRI	2	1275	April 17, 2024
🇪🇺 EDQM - Certification of suitability to Monographs of the European Pharmacopoeia	1	483	April 12, 2024
EMA - Update Appendix 3: Enhanced Ames Test conditions for N-nitrosamines	8	1322	April 2, 2024
USP-NF General Notices Revision open for Comments USP-Standards	0	954	March 7, 2024
Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products Excipients	3	941	March 7, 2024
CDER Drug Safety Priorities Fiscal Year 2023 FDA	1	529	February 16, 2024
New ICH Guideline Q14	0	400	February 12, 2024
Nitrosamine requirements for probiotics FDA	4	299	February 12, 2024

👨‍💻 Dashboard Containing Published AI Limits

NDSRI , AI , featured

Are you looking for a central place for published AI limits? I have created a dashboard containing Acceptable Intake Limits from FDA, Health Canada and EMA. I am looking for folks that are interest into contributing to …