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 we explore the controls needed to both approve Pharma suppliers and to control the purchasing of materials from them
In this video, we look at “The roles of the Heads of Production & QC and the Qualified Person” and what GMP’s requirements are when it comes to roles and responsibilities as well as the specific duties of these three individuals.
Most of you will already have a QMS that has already been designed so the contents of this video will help you to consider how you can evolve an existing QMS to cope with new regulatory requirements, QMS ideas and business pressures. In this video we begin to examine...
This article will consider the concept of “quality” and looks at how a range of experts in this field have arrived at various quality definitions.
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 Systems
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?
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.
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.
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.
It is no longer clear in GMP exactly who should review batch records!
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