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

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. See and download our Auditing Brochure detailing our courses and services in this important area.

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

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

Annex 1 2022 Section 7: Personnel

In this article, we move onto the personnel section, section 7.

Annex 1 2022 Section 6: Utilities

In this article we expand upon the equipment section but looking at Utilities as described in section 6.

Annex 1 2022 Section 5: Equipment

In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

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:

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.

Click on course name for full course details and dates:

Pharmaceutical GMP Auditor/Lead Auditor

Advanced Good Manufacturing Practice

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

Webinar: Microbiological control in pharmaceutical production 

QP Courses - full range

See and download our Auditing Brochure detailing our courses and services in this important area.

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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