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Annex 1 2022 Section 10: Quality Control (QC)

This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

Annex 1 2022 Section 9: Environmental and Process Monitoring

This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities.

Annex 1 2022 Section 8: Production and Specific Technologies – part 3

In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles.

Annex 1 2022 Section 8: Production and Specific Technologies – part 2

This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

Annex 1 2022 Section 8: Production and Specific Technologies – part 1

This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

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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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 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

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GMP Problem Solving

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Sterile Products

Webinar: Microbiological control in pharmaceutical production 

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Data Integrity

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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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