Given the content of warning letters mailed recently by the FDA, perhaps the time is ripe for manufacturing support services "at the touch of a button," as Vectech Pharmaceutical Consultants International promises in its virtual GMP consulting service.
Recent regulatory foul-ups at generics makers Ranbaxy and Caraco--and even at venerable Tylenol maker Johnson & Johnson--demonstrate the need for such consulting convenience. A quick videoconference may have sufficed for reminders to thoroughly investigate batch failures, for example, or to review and approve batch records for compliance with procedures before batch release.
Such conversations hardly warrant an on-site visit by a consultant. Nor would a coaching session on how to maintain consistency between the failure analysis you report in a response letter and the actions and records seen by FDA inspectors during their visit.
The virtual consulting service uses high-definition videoconferencing equipment and collaboration software, says Vectech in an announcement, providing clients with on-demand access to GMP experts without the travel expense. "Manufacturers need support services that are both cost-effective and time sensitive," says Vectech Chairman Franco DeVecchi.
- here's the release