USFDA delivers strong message to pharma companies on quality culture & data integrity
USFDA delivers strong message to pharma companies on quality culture & data integrity: The US Food and Drug Administration (USFDA) seems to have sent out a strong message to pharmaceutical companies in India on the need to adhere to a quality culture and on matters relating to data integrity. This was as part of 'Advanced GMP (good Manufacturing Practices' workshops that the US and European regulators conducted across four city of India between November 6th and 17th. Various presentations were made during these but one that needs particular mention is the USFDA paper titled: "Current Trends in Quality and Data Integrity Trends - Is it a Myth or tip of the iceberg?" As is apparent from the paper, now posted on the website of the Indian Pharmaceutical Alliance, the number of warning letters issued by the Office of Manufacturing Quality of the USFDA to pharmaceutical companies has shot up and this is mainly on account of increase international warning l...