For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 [email protected]

Pharma supplier selection, approval and management

In this article we explore the controls needed to both approve Pharma suppliers and to control the purchasing of materials from them

Online GMP and GDP courses approved by the Royal Society of Chemistry

We are very pleased to announce that the Royal Society of Chemistry has just approved our suite of online Pharma compliance/refresher training courses

The roles of the Heads of Production & QC and the Qualified Person

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.

The importance of assigning GMP roles and responsibilities

The video in this article is part of a unit in our online QMS courses that looks at how to implement a Quality Management System and, in this video, we look at the first principle associated with such implementation – that of adequately assigning roles and responsibilities.

Ensure your team understand the importance of Data Integrity

Now Available - online Data Integrity training for your team Our 20-minute online Data Integrity training course will ensure your entire team understand the importance of Data Integrity and their...

GMP News and Articles

Read our articles on pharmaceutical GMP regulatory developments as well as news about our pharmaceutical training courses. The 5 most recent GMP news articles are shown in the slider and the rest are shown in date order below.

If you have some GMP news you would like us to publish then please contact us.

New EU GMP Directive published

New EU GMP Directive published

The European Union has published its new Directive for pharmaceutical manufacturing sites that is to replace the existing Directive (Directive 2003/94/EC) for human medicines. From having an initial look at the new Directive, here are a few comments.

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Must, Shall and Should – the use of these words in GMP

Must, Shall and Should – the use of these words in GMP

What is the difference in meaning between these words in the context of GMP?, In this post I explain, using EU GMP as my point of reference, although as you will find out, there are occasions within EU GMP where the incorrect terms have been used.

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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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Standards to use when auditing suppliers

Standards to use when auditing suppliers

If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. GMP does not really tell you what pharmaceutical supplier standards you should or could use when auditing your suppliers this post lists of all the key standards to use when auditing suppliers including links to all of the key documents and authorities.

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EU GMP Chapter 9: Self-Inspection – time for an update?

EU GMP Chapter 9: Self-Inspection – time for an update?

In the past few years eight of the nine chapters of EU GMP have been updated. However, Chapter 9 has not been updated at all. This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too? Here are my thoughts

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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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Launch of short on-line GMP course

Launch of short on-line GMP course

Now available – a 1-hour on-line course designed to introduce people new to the pharmaceutical industry to the main requirements of Good Manufacturing Practice with versions for Warehouse, Packaging and Manufacturing personnel

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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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Forthcoming Public Courses

September

23 Pharma GMP Lead Auditor

October

8 Data Integrity

10 Good Manufacturing Practice

15 Responsible Person

22 Advanced GMP

November

Pharma GMP Lead Auditor Manchester, UK

6 Documentation and Records

7 Good Distribution Practice

12 Pharma Internal Auditor

19 Sterile Products

26 Pharma Problem Solving

December

Pharma GMP Lead Auditor 

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

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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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