To successfully comply with GMP requirements, you must look beyond the surface of an issue — or potential problem — to identify its root cause and consider how it impacts all other aspects of operation.

GMP inspector Lea Joos highlights 12 case studies from her inspection practice. Frequent Deficiencies in GMP Inspections analyzes where manufacturers went wrong and provides recommendations to avoid the same pitfalls. Each case study notes the section of the EU GMP Guide related to the violation.

The e-book discusses the following 12 deficiencies:

Immature risk management
Inadequate handling of deviations
Inadequate handling of changes
Insufficient maintenance of rooms
Insufficient cleaning validation
Insufficient process validation
Insufficient traceability of the batch documentation
Inadequate labeling of the status/usability of cleaning materials
Insufficient consideration of electronic or hybrid data paths
Insufficient instructions for handling out-of-specification (OOS) results
Inadequate communication on decisions
Insufficient traceability of complaints

Non-compliance can be expensive. Learn from others’ mistakes before they become your problem!

Weitere Informationen

Reading Sample "Frequent Deficiencies in GMP Inspections"

Jetzt ansehen

Zurück zum GMP-Shop

Bewertungen können anonym erfolgen und werden nach Überprüfung in unserem Webshop veröffentlicht.

Zurück zum GMP-Shop

Quality Management

Zurück zum GMP-Shop

Technical Requirements

This file is in PDF format!
Filesize: 2,84 MB

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

https://get.adobe.com/de/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.