A regulated laboratory is any facility whose processes, records, or outputs are subject to oversight by a regulatory authority. In practice this covers Good Manufacturing Practice (GMP) quality ...
The US Food and Drug Administration’s (FDA) interest in rooting out data integrity deficiencies among Indian pharmaceutical manufacturers continued this month with a warning letter issued to Hyderabad ...
The US Food and Drug Administration (FDA) on Tuesday released a warning letter to India-based Ipca Laboratories after inspections at three of its manufacturing facilities revealed data integrity ...