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A Pharma Guide to Cleaning Validation
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How to meet Agency Expectations and Establish Accepted Limits

Excerpt from the GMP Compliance Adviser
Edition: First edition, 06/2018
61 Pages
ISBN: 978-3-95807-099-8
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines? And are you already familiar with the new requirements for establishing limits in cleaning validation?

Michael Hiob, a German Ministerial Pharmaceutical Director and former GMP inspector, gives a comprehensive overview on agency expectations and tells you how to set up a risk-based cleaning validation in consideration of the lifecycle approach for products and processes.

Dr. Jens Hrach, toxicologist, explains what the new PDE approach is about and points out its implications for cleaning validation.

Cleaning validation is not new, but the official requirements were updated in the revised Annex 15 in order to reflect the current state of the art. Three aspects are in the foreground:
  • The lifecycle of the process should be taken in consideration.
  • A quality risk management approach should be applied.
  • Limits for the carryover of product residues should be based on a toxicological evaluation (PDE report).

The Pharma Guide to Cleaning Validation will show you exactly what 'done correctly' is. The report includes:
  • Regulatory aspects
  • Cleaning process requirements
  • Risk management
  • Design phase
  • Validation phase
  • Ongoing verification/revalidation
  • Documentation
  • PDE Guideline of the EMA
  • Calculating the maximum allowable carryover
  • Visually clean
  • Microbiological state

Every page offers practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.

Order now your copy of A Pharma Guide to Cleaning Validation: How to meet Agency Expectations and Establish Accepted Limits!

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Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

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  • The invoice will be sent by postal mail as soon as possible.
  • Persons who are responsible for the cleaning validation in the areas of quality management, quality assurance, quality control and production
  • External service providers who support cleaning validation
  • Persons who are responsible for cleaning validation documents
Borchert, Dr. Doris

Doris Borchert has been working as an editor for Maas & Peither GMP Publishing since 2008. She is responsible for reviewing expert articles. Prior to this, she worked in the pharmaceutical industry for 15 years in quality assurance, process technology and production and was actively involved in many audits and inspections.

Hiob, Dr. Michael

After graduating in Pharmacology and receiving a PhD, he worked as Laboratory Manager and GMP Inspector. He is currently responsible for supervising GMP inspections. As a ministerial advisor, he is currently responsible for supervising GMP inspections.

Hrach, Dr. Jens

Jens Hrach is Global Submission Manager at Boehringer-Ingelheim. He founded his own company, Dr. Jens Hrach Consulting in 2014, supporting pharmaceutical companies in the areas of toxicology and risk evaluation.

Managing Process Validation
Qualification and Validation: Agency Expectations
GMP Compliance Adviser
Single User Licence (monthly subscription)
Inspection of Process Validation