Industry Guide to handle OOX Test Results
What is the GMP-compliant approach and what do the single steps in the process flow look like? Our e-book picks up these questions and gives a concise overview of the OOX process.
1st edition 2015
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 e-book 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?
Reading Sample "Industry Guide to handle OOX Test Results"
This file is in PDF format!
Filesize: 1,1 MB
To view PDF files, we recommend using the Adobe Reader.
The e-book is password protected to prevent copying and modification of content.
Please note the following procedure guidelines:
For payment by invoice:
- You will receive an advance invoice by e-mail within 1-2 working days. You payment is required for the download.
- After receipt of payment you will receive an e-mail with the download information.
When paying by credit card:
- Immediately after the credit card payment you will receive an email with the download information.
- Your invoice will be sent in a separate e-mail within 1-2 working days.
93.09 - 7.00
369.15 - 7.00
Please select your currency