Warning letters, 483s, Recalls, Import Alerts, Audit observations
EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15
USFDA has issued a new guidance for primary batches to be included in the CMC
European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in
Each Drug Establishments (Registrants*) registered with FDA must provide information on amount of each listed
The draft guidance Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
This guidance provides procedures for ANDA applicants who wish to pursue a request for reconsideration
FDA has published a revised guidance on quality considerations for topical ophthalmic drug products –
The revised monograph for Propylene Glycol (PG) includes test for Ethylene Glycol (EG) and Diethylene
FDA uses Remote Regulatory Assessments (RRAs) to assess compliance of facility with applicable laws and
In the guidance FDA describes use of alternative tools to assess manufacturing facilities identified in
