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.

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

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”.

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.

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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Basic audit findings and EU GMP clauses

Basic audit findings and EU GMP clauses

This article lists a number of common basic audit findings and the corresponding clause in EU GMP that is relevant. Readers should note that there is often some repetition in GMP, so I have tried to find the best single clause.

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Exciting news – the classroom returns

Exciting news – the classroom returns

News Update – traditional classes to complement our ‘live online interactive’ format; new January date for Lead Auditor course; new versions of our online courses.

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New live online interactive format a great success

New live online interactive format a great success

All of our training courses are now being delivered using our ‘live online interactive” format. Making the transition away from classroom delivery has been challenging especially for the team delivering our highly successful and intensive 5-day Pharmaceutical GMP Lead Auditor course. But the reviews in this article show how we have risen to that challenge.

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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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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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