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The Concept of Quality and Quality Definitions

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.

The Concepts behind Modern QMS Thinking

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

Management Review – who, what, where and when?

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?

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.

Data Integrity – why all the fuss?

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.

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Key GMP personnel and their duties

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.

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The positioning of the Qualified Person (QP) within the organisation

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. 

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Duties of key personnel in GMP – Part 3 (Engineering)

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.

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Duties of key personnel in GMP – Part 2 (Quality Assurance)

From Part 1 of this post we highlighted that there is no formal need for a QA Manager or Department in GMP.  EU GMP does require you to have a QA system, but there is no mention of who should manage the system.  In a number of courses that I have presented in the past...

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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.

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Forthcoming Public Courses

November

13 Internal Auditor
20 Sterile Products
27 Problem Solving

December

03 Pharma GMP Lead Auditor Now Full

January 2019

21 Pharma GMP Lead Auditor

Febuary 2019
12 Data Integrity

All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.

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Data Integrity

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Pharma Quality Management Systems module

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QP Quality Management Systems module

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