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 …
PharmOut congratulates DSM and BPA on passing their TGA GMP inspection and the recent opening of their state of art cGMP Facility in Brisbane
DSM Pharmaceutical Products has just opened its new cGMP facility for biopharmaceutical contract manufacturing in Brisbane.
Built in partnership with BioPharmaceuticals Australia (BPA) and with cooperation from the government of Queensland and the Commonwealth of …
Wireless Sensors in a GMP Environment
I am often asked about wireless sensors in a GMP environment and their application. They are a very attractive option for retrofitting an existing facility because they are easy to install, tailor to the …
TGA Launches Pilot of Medical Device Single Audit Program
The Therapeutic Goods Administration (TGA) yesterday announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the …
EMS or BMS… what are they and should they be separate?
An Environmental Monitoring System (EMS) is very different from a Building Management System (BMS) – an EMS monitors the environment of a facility, whereas a BMS controls the environment.
What are the options?
There are many …
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:
…