The FDA’s GMPs and the EU’s GMPs are supposed to be harmonized. Supposed to be. The reality is there are subtle but significant differences between the two.
The EU specifically calls for periodic reassessment of training effectiveness; The FDA does not.
The EU allows a test-until-clean approach to cleaning validation; the FDA does not.
EU requirements for retention of samples are more specific than the FDA’s.
The FDA requires proof that OTC packaging is tamper resistant; EU does not.
The FDA has requirements for a GMP audit; EU does not.
And the list goes on. If you think because you passed your last FDA inspection, you’re ready for EU inspectors, you could be sadly mistaken.
This new handbook from FDAnews tells you what you need to know about the similarities — and subtle differences — between FDA and EU GMP inspections.
FDAnews reached out to four authorities on European drug manufacturing quality for their expertise. The result is a handbook you’ll refer to whenever the EU inspectors come to call.
This plain-English guide touches all the bases:
What types of inspections EU drug regulators conduct
The qualifications of inspectors
The formula used by regulators for determining priority order and frequency of individual inspections
Sample inspection documentation
Contents of an inspection report
And much more
Co-authors represent the state of the art on current good drug manufacturing practices:
Dr. Michael Hiob is supervising surveillance member of the Expert Group on Qualification/Validation for the State of Schleswig-Holstein, Germany. He previously served as head of the Laboratory for Drug Analysis and GMP Inspector for the Regional Authorities for Health and Occupational Safety of the State of Schleswig-Holstein.
Max Lazar retired from Hoffman-LaRoche Inc. as VP for FDA and DEA Compliance. He now is a consultant specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance.
Dr. Christian Gausepohl heads Quality Assurance at Rottendorf Pharma GmbH. In 13+ years with Rottendorf Pharma, Dr. Gausepohl has served as coordinator of technology transfers and process optimization, head of dosage forming, production manager, and head of product transfer and process validation.
Dr. Christine Oechslein is a veteran of 23 years in drug manufacturing and development, mostly with Sandoz and Novartis. She developed oral drug delivery systems, headed a lab for development of nasal and pulmonary dosage forms, and helped create a quality manual for Rx development.
With this team of experts at your back, you’ll sail through your next EU drug GMP inspection. So don’t wait.
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