FDAnews Management Report: Preparing for the EU GMP Inspection

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A self-inspection is not only a good way to prepare for an actual inspection, it’s also required under EU GMP regulations. Preparing for the EU GMP Inspection will familiarize manufacturers with exactly what to expect when EU inspectors arrive, as well as provide guidance for how to conduct self-inspections.

Preparing for the EU GMP Inspection
**FDAnews Management Report**

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. Just because a company passed its last FDA inspection, it doesn’t mean it is ready for EU inspectors.

This new management report from FDAnews tells 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 to refer to whenever the EU inspectors come to call.

Preparing for the EU GMP Inspection 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
  •     Self-inspection checklist
  •     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 expert-written guide, quality managers will know exactly what to expect from EU GMP inspections, and how to prepare using their own self-inspections. Order Preparing for the EU GMP Inspection today.

Preparing for the EU GMP Inspection
**FDAnews Management Report**

FORMAT: Print or PDF
PRICE: $397

Online:    http://www.fdanews.com/EUgmp
By phone: 888-838-5578 or 703-538-7600

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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