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Annex 1 2022 Introduction and background to the update

Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1,...

ISO 9001 versus GMP – Part 2

One of the main problems of comparing GMP and ISO is that the two standards are not the same and are not really trying to do the same thing. This article highlights the key differences.

ISO 9001 versus GMP – Part 1

ISO 9001 versus GMP – this article lists the clauses of ISO 9001:2015 identifying requirements of ISO that are not specifically mentioned in EU GMP

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.

Design Criteria for an Effective QMS

Design Criteria for an Effective QMS

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...

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The Concepts behind Modern QMS Thinking

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

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Management Review – who, what, where and when?

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?

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Data Integrity – why all the fuss?

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

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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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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Our Public Course range

Most of our public courses are currently being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together. In 2022 we began to once again offer traditional classroom courses - see details on each course page.

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Pharmaceutical GMP Auditor/Lead Auditor

Advanced Good Manufacturing Practice

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

QP Courses - full range

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Online courses available anytime anywhere 

Data Integrity

Good Distribution Practice (GDP)

Good Manufacturing Practice (GMP)

Pharma Quality Management Systems module

QP Medicinal Chemistry & Therapeutics module 

QP Quality Management Systems module

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.

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