Root Causes
| Topic | Replies | Views | Activity | |
|---|---|---|---|---|
| Nitrosamines - Elastomers perspective (PDA publication) |
|
8 | 825 | October 16, 2021 |
| Results from survey on Nitrosamines in Excipients -Any thoughts? |
|
10 | 813 | September 23, 2021 |
| Excipient & Nitrosamines -Q&A session |
|
0 | 348 | September 16, 2021 |
| Challenges for API Raw Material & DP regarding Excipient / APIs / Packaging? |
|
12 | 1572 | August 17, 2021 |
| Many excipientsuppliers are using the IPEC Questionnaire for Excipient Nitrosamine Risk Evaluation to conduct nitrosamine risk assessments. Does FDA accept prepared questionnaires,such as the one developed by IPEC, as a valid risk assessment tool? |
|
0 | 409 | July 20, 2021 |
| Developing Process for Nitrite-free Excipients? |
|
1 | 595 | July 11, 2021 |
| Most burning challenge for API manufacturers? |
|
10 | 979 | May 27, 2021 |
| Are we ready to inlcude Nitrosamine testing on Inhalation Packaging/Delivery systems? USP: Nitrosamines in Elastomeric Components for Inhalation |
|
0 | 367 | April 27, 2021 |