In a recently published warning letter, the FDA cites Vilvet Pharmaceuticals of hiring an auditor to check a contract manufacturer, but of having no results or conclusions on the audit.
The letter was issued to Vilvetfollowing an inspection of its drug manufacturing facility in Chester Springs, Pennsylvania, from June 18 to 27, 2018.
The US agency said the company failed to establish appropriate written responsibilities and procedures for the control of externally produced batches.
The company had asked the contract manufacturer to take over manufacturing and packaging activities.
The quality agreement stipulated that both sides were responsible for compliance with the relevant cGMP requirements, while the contract manufacturer was solely responsible for the approval or rejection of all products.
However, the FDA does not allow the final control and approval to be assigned to an external partner; however, it would be possible according to EU GMP.
The FDA considers the marketing authorisation holder and contract giver to be responsible for the final review and approvals of all batches. For the US agency, this should also be described in the contract.
Warehousing has also been assigned. According to the FDA, storing drugs in an external warehouse is a cGMP activity.
The selected warehouse, however, had declared that this was "not applicable" and that the employees were not trained in GMP either.
According to the FDA, the warehouse should never have been approved and used.
For more details please also see the FDA Warning Letter to Vilvet Pharmaceutical.
N.B.This article was originally published by ECA on its website www.gmp-compliance.org.
