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Agency Expectations for Qual/Val

LOGFILE 01/2019 – January 2019


Dear Colleague,

What will the authorities certainly look at in 2019? Of course, the proper implementation of qualification and validation according to Annex 15 of the EU GMP Guide.

Qualification and validation are perennial and critical issues in pharmaceutical processes that need constant attention.

Qualification and Validation: Agency Expectations is a “must have” guidance for all those who are involved in qualification and validation. Ministerial officer and former GMP inspector, Michael Hiob, highlights all relevant expectations of the authorities.

Today you'll get the exclusive chance to read an excerpt from the download regarding Design Qualification (DC) - one of the most important steps of the whole validation process.

Sabine Paris



Qualification and Validation: Agency Expectations

The practical implementation of qualification and validation raises many questions. How do you correctly use risk management? By what means can the life cycle concept be realised? How do you organise planning, performance and documentation efficiently and in a GMP-conform manner? And most important of all, what are the expectations of the responsible authorities?

In the report Qualification and Validation: Agency Expectations Michael Hiob provides all the answers. It is a “must have” guidance for all those who are involved in qualification and validation

You'll learn in detail about:

  • The Regulatory requirements for qualification and validation
  • Risk management and life cycle concepts
  • Organisation and responsibilities
  • Performance and documentation

Excerpt from the GMP Compliance Adviser

>>> Read Now: Excerpt from Qualification and Validation: Agency Expectations - Design Qualification (DC)

Get started now!

Order your copy of the complete GMP-Series Download
Qualification and Validation: Agency Expectations - GMP-Conform Implementation of Annex 15 EU GMP Guide


GMP Question of the Week

Why should inactivating agents be added to the culture media when performing tests for microbiological monitoring?

>>> Click here to read the answer


GMP News

We couldn't identify any significant news this week.
We will keep you updated.

>>> Read the previous news


GMP Compliance Adviser

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The GMP Compliance Adviser is also available as a monthly subscription:

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