+44 1635 866699 [email protected]

GxP and GMP Consultancy

We provide clients globally with GXP and GMP Consultancy expertise including auditing services, inspection preparation, Inspection remediation and QP release

GXP and GMP Consultancy

As well as offering training courses we also provide pharmaceutical GxP and GMP consultancy and auditing services.  For this we only use leading industry specialists.  Specialists who not only have a great deal of experience but also have practical skills and ability to get issues sorted.  Our idea is that our consultants should be able to work with you and help you, rather than create even more work for you!  We can help with the following areas of the pharmaceutical industry:

Auditing service

We perform supplier audits as well as internal audits against most recognised pharmaceutical standards.  We use specialist sector-specific auditors as needed, including experienced IT/ Computer System auditors.

Inspection preparation

We help get sites ready for Regulatory and Corporate inspections, including working with groups to get their own areas ready.  We can also assist behind the scene during the inspection itself.

Inspection remediation

Not all audits go well, and we can help get sites that have had poor inspections back on their feet.

 Qualified Person release

Many of our consultants are eligible to act as Qualified Persons (QPs), and so we can provide locum QP support when needed.

Recent projects have included:
Selecting possible new manufacturing site in Asia
  • 5 sites in Malaysia were identified as possible manufacturing sites for a new medicinal product.
  • All were audited to GMP (to look for compliance), suitable technology transfer skills and the ability to supply product on time.
  • A short list was created and on-going partnership discussions continue.
Selecting possible supplier of an Active Pharmaceutical Ingredient
  • A number of potential sites in Asia were identified.
  • All were audited to API GMP.
  • A short list was created and business discussions continue.
Support for development of European QA Managers
  • A number of new QA Managers at Country Business Units (Affiliates) around Europe have been supported over the past 5 years.
  • Many were new to GMP.
  • Included audits of their offices and gap analysis against company requirements.
  • Followed by support and ongoing training and development.
  • QA Managers now have a much greater appreciation of the rules and regulations of EU GMP.

If you would like to find out more please send an email with your details and we will be in touch.

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

QP Training

GDP Compliance

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.

Successful Japan Lead Auditor course

We successfully delivered our highly praised GMP Auditor/ lead Auditor training course in Osaka, Japan, for the third time a few weeks ago. The course will be presented again in Osaka next year in early March 2020

QP Medicinal Chemistry course approved by Royal Society of Chemistry

We are very pleased to announce that our online QP Medicinal Chemistry and Thereupeutics module has recently been approved by the Royal Society of Chemistry. Read this article to access some of the video content from this online course.

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...

Inspired Expanding Overseas

2018 saw an increasing number of overseas delegates attending our UK and Ireland public course programme. We also conducted a number of consultancy assigments in the US and the Far East as well as delivering many onsite courses to overseas subsidiaries of our UK pharma clients. And we succesfully delivered our 5-day Pharmaceutical GMP Auditor / Lead Auditor course in Japan. So, we are excited that this new year takes us to new shores, as we also now plan to export our expertise to the Middle East and India.

NEW: Responsible Person course scheduled for 2019

News about our new 3-day Responsible Person course will confidently set budding RP’s on a path to becoming qualified in a much shorter timeframe than other 2-day courses 

Pharma News and Articles

Read our articles on  Pharma regulatory developments as well as news about our Pharma training courses.

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.

Quick Links

Find your way quickly to any  part of our website by selecting any of the links in this section

Forthcoming Public Courses

June

4 Pharma Internal Auditor

11 Responsible Person

13 Good Manufacturing Practice

18 Sterile Products

24 Pharma GMP Lead Auditor Dublin, Ireland

July

15 Pharma GMP Lead Auditor 

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

For all 2019 dates select the green 'See all Courses and Dates' button above or to the left.

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.

Why not subcsribe to our mailing list to try a free Taster  of these courses to see if they are of interest?

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