QP News and Articles
Read our articles on regulatory developments of interest to trainee and qualified QP’s as well as news about our pharmaceutical training courses. The 3 most recent QP articles are shown in the slider and the rest are shown in date order below.
In this article and video we look at some general systems thinking points and consider the structure of a Quality Management System together with the underlying concept of Quality Management principles – the “oil” used to maintain our Quality Management System. Taken from Unit 01 Chapter 03 of our QPharma/QP course on Quality Management Systemsread more
The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so. In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real shame. So what are these GMP Management Review meetings, why do we have them, what should be discussed, who should attend and how often should we have them?read more
The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.read more
Some of the most popular articles on our blog are the four we published some four years ago about the duties of key personnel in GMP. For more recent visitors to the blog I thought it might be helpful to remind everyone about this resource.read more
Chapter 8 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.read more
It is no longer clear in GMP exactly who should review batch records!read more
A new update to EU GMP Chapter 2 has been issued and comes into operation on 16th February 2014. Here is a summary of the main changes.read more
After a longer period of review and many draft versions published the final update to EU GMP Chapter 1 on “Quality Management” comes into operation on 31st January 2013. Here is a summary of the main changes.read more
In previous posts we have looked at the Roles and Responsibilities of the 3 Key Personnel required by EU GMP, namely the Head of Production, the Head of Quality Control (QC) and the Qualified Person (QP). In this post we look at the organisation of these people within the business.read more
From Parts 1 and 2 of this post we highlighted that there is no formal need for an Engineering Manager or Department in GMP. In the manufacture of medicines the equipment used and the environment it is located in has a massive impact on product quality. The role of the Engineering Manager is therefore critical.read more
About Inspired Pharma
We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.
Use the tabs below, and above in the header, to select more articles on specific topics of interest
Find your way quickly to any part of our website by selecting any of the links in this section
Forthcoming Public Courses
13 Pharma GMP Lead Auditor Central London, UK
24 Pharma GMP Lead Auditor Dublin, Ireland
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
For all 2019 dates select the green 'See all Courses and Dates' button above or to the left.
Online courses available anytime anywhere
Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.
Why not subcsribe to our mailing list to try a free Taster of these courses to see if they are of interest?