+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

What to include in an audit report

An audit report is an essential part of the audit and this article lists the key items that you should ensure are in your audit report contents.

A Quality Manual – what is it and what should it contain?

A Quality Manual is a very useful document that not only gives guidance and direction to an organisation’s own personnel, but gives a potential customer, inspector or auditor an appreciation of an organisation from the outside. If designed well it can be used as a tool to sell an organisation, to show what a positive quality ethos they have and can show how good an organisation is and how seriously it takes its Quality Management System.

Planning to perform audits

As with everything else in life, planning is everything. An audit is much more effective for everyone concerned if the auditor takes a short amount of time to plan the audit correctly. This article incudes a checklistlist of things to include in the planning of any effective audit.

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...

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.

What Pharma Companies Need to Know about Measuring Instrument Calibration

According to pharmaceutical cGMP (current Good Manufacturing Practice) guidelines, pharma companies need to conduct regular instrument calibration as part of their validation and qualification activities. This article gives an overview of what is involved.

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.

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?

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

October

17 Good Manufacturing Practice

November

05 Pharma GMP Lead Auditor Manchester, UK
13 Internal Auditor
20 Sterile Products
27 Problem Solving

December

03 Pharma GMP Lead Auditor

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

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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