Dispatches from CPhI
Around 80% of data integrity issues QC related, says CPhI expert
Increased efforts by the US FDA have made data integrity the hot topic on GMP compliance, according to a regulatory expert.
Dispatches from CPhI
Increased efforts by the US FDA have made data integrity the hot topic on GMP compliance, according to a regulatory expert.
API suppliers should be allowed to make process improvements without having to seek re-approval says consultant Girish Malhotra, who argues that the current rules create inefficiency and waste.
Dispatches from CPhI
Big Pharma has returned to Europe for its API sourcing due to reasons of quality and reliability, according to the European Fine Chemicals Group (EFCG).
CPhI Worldwide 2015
Dow has revealed a polymer for multi-particulate drugs that it says is solvent-free and bypasses slow-drying water-based methods.