GxP and GMP ConsultancyWe 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
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
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.
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
- 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
supportand 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
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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.
Find your way quickly to any part of our website by selecting any of the links in this section
Forthcoming Public Courses
12 Data Integrity
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
For 2019 dates select the green 'See all Courses and Dates' button above or to the left.
Online courses available anytime anywhere
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.