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LOGFILE

A Play in 3 Acts: Inspections & Audits

LOGFILE 14/2018 – April 2018

Contents

Dear Colleague,

Yes, audits and inspections can be compared with a play in three acts. Because they usually consist of three parts: Preparation – Carrying out – Follow-up.

The entire “play” should be viewed as being a win-win situation for everyone involved. Audits and inspections ideally are an opportunity for optimising the processes in the company and for continual improvement.

Appropriate preparation is the alpha and omega of a successful inspection. If your preparations are good, you're half way there!

Today's feature tells you what you should consider when an audit/an inspection is on the doorstep. It's the second part of a summary of the questions and answers that were discussed during a GMP dialogue at our annual GMP conference, the GMP-BERATER Tage 2017.

Regards,
Sabine Paris







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Inspections & Audits: Pitfalls and Criteria for Success - Part 2

What are the requirements regarding (most) of the small-volume suppliers? – “Questionnaire” versus “On-site audits” – Why is it necessary for external typesetting studios to be audited? How should I approach known areas of weakness? Discuss them openly or wait and see?

These questions and many more are answered in today's feature. It's the second part of a summary of the questions and answers that arose during a GMP dialogue at our annual GMP conference, the GMP-BERATER Tage 2017. The first part was published in LOGFILE 13/2018.

>>> Read now: Inspections & Audits: Pitfalls and Criteria for Success – Part 2







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GMP News: EMA

2018-04-06
EMA: Public Consultation on GMP Non-compliance Statement
On 3 April 2018, the EMA has published a 4-page public consultation document concerning the European Union template for GMP non-compliant statement. The GMP/GDP Inspectors Working Group is currently discussing possible actions required if inspections conclude with serious GMP non-compliance when at the same time this conclusion would block the availability of life-saving medicines. “What happens when?” is the question that EMA is now putting up for public discussion.
Read more ...







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GMP Question of the Week

Who is responsible for generating the PQ protocols?

>>> Click here to read the answer








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Succeed your next EU GMP Inspection

Do you want to take your company to the next level of inspection preparation? What about succeeding with proven tools?

Our pdf download Preparing for the EU GMP Inspection tells you all you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections. It is an excerpt from the unparalleled GMP Compliance Adviser - the unique GMP knowledge source for the drug industry.

Did you know that EU inspectors ask for periodic reassessments of training effectiveness - and the FDA does not?

In this valuable and helpful download you learn about:

  • Differences of EU and FDA inspections
  • 4 Types of European inspections
  • Qualification of inspectors
  • 7 steps to succeed GMP inspections
  • Regulators formula for priority order determination
  • Frequency of individual inspections
  • Practice sample: Inspection documentation
  • Content guidance of an inspection report
  • Detailed Self-inspection procedure and supplier checklist
  • And much more

>>> Click & View: Reading sample

>>> Order now: Preparing for the EU GMP Inspection







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