Der Artikel wurde erfolgreich hinzugefügt.

A Pharma Guide to Cleaning Validation

Geben Sie die erste Bewertung für diesen Artikel ab

Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines? This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.

e-book

61 Seiten

ISBN: 978-3-95807-099-8

1st edition 2018

Lieferung sofort nach Zahlungseingang

117,00 € netto

X

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.


Bewertungen werden nach Überprüfung freigeschaltet.
Bewertung schreiben

Bitte geben Sie die Zeichenfolge in das nachfolgende Textfeld ein.

Die mit einem * markierten Felder sind Pflichtfelder.

  • 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

Technical Requirements

This file is in PDF format!
Filesize: 1,94 MB

To view PDF files, we recommend using the Adobe Reader.

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.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.
  • SOP 503 Reinigung von Räumen und Einrichtungen
    Download

    Nach welchen Kriterien wählen Sie Dienstleister für de Raumreinigung aus?...

    85,00 € netto

  • SOP 505 Reinigung und Reinigungsvalidierung
    Download

    Reinigungsverfahren müssen anhand schriftlich festgelegter und validierter...

    199,00 € netto

    • 1 named user
    • 3-month-subscription
    • €107 / US$128.40 per month
    • ...

    321,00 € netto

  • How to design a Laboratory Data Management System
    Download

    The introduction of a LDMS has an extremely positive impact on the efficiency and quality of...

    87,00 € netto

  • GMP-LOGFILE

    Newsletter

    Lesen Sie GMP-News und informative Beiträge zum Thema GMP in unseren kostenlosen GMP Newsletter "LOGFILE".

    Anmelden