For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 info@inspiredpharma.com

Do QC labs work to GLP?

This is a commonly asked question on my training courses which is generally misunderstood.  Quality Control (QC) laboratories that are based at classic pharmaceutical manufacturing sites DO NOT work to GLP.

The benefits of being IRCA registered

Our 5-day Pharmaceutical GMP Auditor/Lead Auditor Course is registered with IRCA, the International Register of Certificated Auditors (IRCA Ref:PR325).  This is the world’s premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses.

Raising non-conformities

Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit.  This is somewhat of an old-fashioned way of auditing.This article the best way of dealing with non-compliances using modern standards.

History of the Orange Guide

This article provides a brief overview of the history of this book and also covers why it is certainly no longer a guide.

Documents required by USA GMP (21 CFR 211)

The article covers the requirement of written procedures required by 21 CFR 211

Pharma News and Articles

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

What is a medicine?

What is a medicine?

A medicine is quite a complicated thing, with a number of definitions that go beyond “making you feel better”.   Whilst making you feel better is probably the goal of all medicines you will see in this article that these four words do not appear in the definition itself!

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Inspired Times – Newsletter November 2022

Inspired Times – Newsletter November 2022

"Wow - Amazing - World Class"​ - "truly inspiring training"​ Amazing feedback on our courses Our IRCA registered Pharmaceutical GMP Auditor/Lead Auditor Course continues to received outstanding feedback from delegates. The words in the headline above are just an...

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Documents required by EU GMP

Documents required by EU GMP

The list below details the documented procedures specified as being required by EU GMP. It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.

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GMP Calibration

GMP Calibration

Around a pharmaceutical manufacturing site there will be many measuring devices that require calibration. GMP requires the calibration of such devices with similar requirements in both EU and USA GMP

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CAPA – time for a rethink?

CAPA – time for a rethink?

Most manufacturing sites these days have CAPA systems – a mechanism to capture, record, control and approve or reject Corrective Actions. However despite this approach many organisations feel that they are still in “fire-fighting” mode – always dealing with yesterday’s problems rather than preventing future issues from occurring.

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ISO 9001 versus GMP – Part 2

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.

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ISO 9001 versus GMP – Part 1

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

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The Focus of Audits – Have we got it right?

The Focus of Audits – Have we got it right?

The focus of audits : as a pharmaceutical trainer, auditor and consultant I meet a lot of auditors and look at audit mechanisms a great deal. My impression is that the focus is not always right.

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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.

Other Topics

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Quick Links

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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 will also begin to offer some traditional classroom courses - see details on each course page.

Click on course name for full course details and dates:

Pharmaceutical GMP Auditor/Lead Auditor

Advanced Good Manufacturing Practice

Data Integrity

Documentation and Records in GMP

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

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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