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Quality Unit

Industry Guide to handle OOX Test Results
€ 87.00
net
€ 103.53
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
US$
99.00
pdf download
Managing Test Results out of Defined Criteria

Excerpt from the GMP Compliance Adviser
Edition: First edition, 09/2015
28 Pages
ISBN: 978-3-95807-015-8
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

How to deal with OOX Results

Despite the aura of sensitivity surrounding results outside defined criteria, correct and confident handling of these types of results is crucial and can be used during audits to demonstrate high quality standards. A structured approach also provides very valuable information to improve the standard of quality.

What is the GMP-compliant approach and what do the single steps in the process flow look like? The pdf download Industry Guide to handle OOX Test Results - Managing Test Results out of Defined Criteria picks up these questions and gives a concise overview of the OOX process.

It deals in detail with the following issues:
  • History and significance
  • Terminology and definitions
  • Out-of-Specification (OOS)
  • Out-of-Expectation (OOE)
  • Out-of-Trend (OOT)
  • OOX results during calibration and qualification
  • OOX process during transfer and validations
  • OOX process and outsourcing
  • OOX process and document management system
Our author Dr. Markus Limberger gives answers to the following crucial questions:
  • What is the purpose of the OOX concept?
  • What is the GMP-compliant approach when criteria are not met?
  • What are the different types of cases?
  • For which processes can the concept be used?
  • What is the correct way to document the process?
Purchase your copy of Industry Guide to handle OOX Test Results now.

Technical Requirements

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

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Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
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  • The invoice will be sent by postal mail as soon as possible.
Limberger, Dr. Markus

Markus Limberger is co-founder of the QUASAAR GmbH which has been providing GMP consultancy in product development and product control to the pharmaceutical and life sciences industries since 2015. His areas of expertise include method transfer, OOX process, qualification of standard substances and reagents, auditing and increased efficiency in the laboratory.

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