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EDITORIAL
In these uncertain times, one thing
remains certain: the regulatory focus on pharmaceuticals does not
diminish. MBA provides expert help with all aspects of pharmaceutical
GxP support. Please click
here to see details of how you could benefit by using MBA's
services.
RECENT SERVICES PROVIDED
Pre-MHRA inspection preparation on a project management
basis and training for the UK site of a global contract manufacturer.
The inspection was successful.
Systems assessment,
pre-licensing inspection preparation and training for a UK site of a
global manufacturer. The licence was granted.
Facility assessment, reporting and further recommendations regarding a
refurbished aseptic processing facility in the EU, on behalf of an
insurance company.
Site
preparation of a solid dosage form facility within Europe for a global contact
manufacturer, in advance of a FDA submission and inspection. The
inspection is awaited.
Extensive
assessment, post-inspection remediation and pre-inspection preparation
and training for a UK vaccines manufacturer in advance of both UK and FDA
inspections.
General GMP and specific aseptic training to industry
representatives and inspectors from two regulatory agencies located in
the Middle East. |
Martyn
Becker Associates Global GxP consultants specialising in aseptics and steriles. Good Practice standards
and systems for the pharmaceutical industry.
