New 2016 GMP Quiz
A New Year a New GMP quiz!
You’ve probably already done the old quiz, so test your updated GMP knowledge with the latest PharmOut 2016 GMP quiz.
All new questions have been developed as well and a …
Entries by PharmOut
White Paper – EU GMP Guide – Annex 15 Qualification & Validation draft released
Purpose
This White Paper reviews the proposed changes to Annex 15 of the EU GMP guide in detail. The draft of the revised Annex 15 was released in February 2014 by the European Commission. The …
New Revision of PIC/S GMP Guides (PE 009-11)
March 1st 2014 will see the newest revision of the PIC/S GMP Guide (PE 009-11) come into effect, replacing the previous version PE 009-10 that has been current since January 2013.
2013 Online GMP Quiz iPad Draw Winner
Congratulations to Ian Yinfoo from NSW, Australia. Winner of the 2013 GMP Quiz draw and will be receiving a brand new Apple iPad Air from PharmOut on behalf of our Online GMP Training team.
Thank …
White Paper – Comprehensive Review and Implementation of Risk Management Processes in Software Development
This paper reviews the principles of risk management in software development of GxP systems, elaborates on the well-known risk management approaches and identifies some of the important concepts of proactive management of risks throughout the software development lifecycle.
White Paper – Implementation of ANSI/AAMI/IEC 62304 Medical Device Software Lifecycle Processes
This paper reviews the implementation of the ANSI/AAMI/IEC 62304 Medical Device Software – Software Life Cycle Processes standard.
10 Tips for Writing User-friendly SOPs
In this blog I would like to share my 10 tips for writing user friendly SOPs as part of your GMP Pharmaceutical Quality System.
The other day I was informed by a client that no-one …
Why are our change control numbers out of control?
Many pharmaceutical companies struggle to close change controls. Clients often ask if the problem is caused by too many change requests and what is a reasonable number of open changes.
The issue for most sites …
Cloud Computing in GxP Regulated Environments
Cloud computing is gaining increasing attention from the pharmaceutical and medical device industries – its flexible and cost effective. However, it also presents many questions surrounding the traditional approach to controlling computer systems, including:
…
Consultations on adoption of EU guidelines in Australia
EU guidelines
A number of EU guidelines have been proposed for adoption or non-adoption by the TGA. These are now open for comment until 19 August 2013. The guidelines in question are listed below:
Guideline on …