The US Food and Drug Administration (FDA) has issued warning letters to Korean company Firson Co. and Chinese firm Wuxi Medical Instrument Factory, citing sterilisation violations.
A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.
Pfizer says there were no safety or quality problems with the drugs made at the Chinese site reportedly issued with a 483 for expired materials and missing paperwork.
Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.
Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.
Speciality Compounding has been ordered to cease production by the US Courts after tests confirmed injectable drugs made at its facility in Texas were contaminated by bacteria.
A federal judge in the Southern District of Ohio has approved a US FDA consent decree against Shamrock Medical Solutions for drug manufacturing and labeling violations.
Outsourcing is key for pharma companies and medical device
manufacturers keen to develop and produce "combination products" -
medical devices embedded with a pharma component - according to an
industry player.
