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Root Cause Analysis

LOGFILE 06/2018 – February 2018


Dear Colleague,

Failure investigations are more than must-do quality tasks. They can lead to scrap reduction, rework reduction, cost cuts and process improvements. It’s important to treat the root cause, not the symptoms!

The question is therefore, how to avoid the failures that have occurred in the future. One of the key success procedures is the investigation process in a pharmaceutical company. And a failure management system is also an essential part of continual improvement!

The gold standard of GMP online databases, our GMP Compliance Adviser, outlines how to set up a failure management system and explains how to use root cause analysis methods and tools correctly. Don’t miss the opportunity to read today an exclusive excerpt on root cause analysis as an essential enabler in a pharmaceutical quality management system.

Sabine Paris


Root Cause Analysis - An Essential Enabler

Root cause analysis should be integrated into the quality management system of a pharmaceutical company. It should be a formal independent process of continual improvement and should be used during the entire life cycle of the product.

In today's feature, our author Martin Mayer shows you why root cause analysis is an essential enabler in a pharmaceutical quality management system and why it is so important for the product life cycle.

>>> Read now: Root Cause Analysis - An Essential Enabler – An Excerpt from the GMP Compliance Adviser

>>> More information: GMP Compliance Adviser


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UK and China Sign Memorandum of Understanding
The British MHRA (Medicines and Healthcare products Regulatory Agency) and the China Food and Drug Administration (CFDA) signed a Memorandum of Understanding (MoU) on 1 February 2018.
Read more ...

EC: Report on Transposition of Falsified Medicines Directive
The European Commission (EC) has published a report that takes a closer look at the implementation of the Falsified Medicines Directive 2011/62/EU in the European member states which
  • introduces mandatory safety features on prescription medicines from February 2019 on
  • strengthens good distribution practices and requirements for wholesale distributors
  • reinforces rules on importation, controls and inspections of active substances and their manufacturers, and
  • established an EU-wide logo to allow the identification of legal online retailers of medicines (as of 1 July 2015).
Read more ...


GMP Question of the Week

What is the purpose of adhesive floor mats?

>>> Click here to read the answer


gmp review

gmp review provides in-depth analyses of international pharmaceutical manufacturing regulations.

gmp review keeps readers up to date on the latest Directives, Regulations and Guidelines applicable to the pharmaceutical industry from the FDA, EU, CPMP and ICH positions. Each item comes with analysis and comment on its effect on your company. The dry legal jargon is made understandable to you and your colleagues in manufacturing and quality. As such, gmp review is the perfect companion to the GMP Compliance Adviser and will help provide further useful commentary on the new regulations.

If you are involved in any aspect of GMP then gmp review will provide much-needed information and analysis in a convenient quarterly journal format. gmp review subscribers will also receive gmp-review news, a monthly news service to keep you up-to-date on new developments in GMP and associated regulations.

Annual subscription: £ 190, 210 € and US$ 250 (4 issues)

>>> More information: gmp review

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