With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
The US FDA’s New Inspection Protocol Project represents an “improvement process step” towards a risk-based site selection model, according to the Swedish CDMO.
WHO recently assessed Biopharma Services, which demonstrated compliance across multiple regulatory and organizational guidelines – opening the doors to conduct more work with the WHO foundations.
Risk algorithms and international agreements will help ensure imported API quality, says FDA Commissioner Robert Califf but industry must also take responsibility for its own supply chain.
Several FDA officials are currently visiting India and meeting with manufacturer CEOs and government officials to discuss the way the agency’s inspections are expected to change over time.
Inspecting the thousands of Chinese factories making APIs for the US market is a “hopeless task” even if the FDA gets the extra staff it wants according to a Congressional committee review.
Actavis has reintroduced Oxycodone 15 mg and 30 mg tablets to the US market having resolved the manufacturing difficulties discovered by the US Food and Drug Administration (FDA).
Symetix has launched a compact high-volume optical inspection system that is capable of verifying the colour, size and shape of capsules and tablets and removing defective products.
The US Food and Administration says that a new project examining the interaction between its review and facilities inspection arms will help improve inter-departmental communication, particularly during pre-approval inspections (PAI)
Questions are hanging over the role of a Chinese manufacturing
facility in the Baxter heparin scare after it has emerged that the
US Food and Drug Administration (FDA) has never inspected the
facility.
Key Technology subsidiary Symetix has launched a new inspection
system fortablets, capsules, and softgels called Vantyx that it
claims can achieve 100 percent, in-line inspection at full
production speeds.