GDP & RP News and Articles
Read our articles on GDP and Responsible Person (RP) regulatory developments as well as news about our courses in this area. The 5 most recent articles are shown in the slider and the rest are shown below.
New course on Data Integrity
This course has already run very successfully on an in-house basis for our clients who are increasingly concerned to ensure that they comply with the latest regulations from the EU and the FDA regarding the data integrity of their systems.
read more
MHRA publishes new GMP Data Integrity Guidance
Hot off the press – find out more about new guidance from the MHRA on GMP data integrity expectations for the pharmaceutical industry.
read more
The main differences between GDP and GMP
The European Union’s guidelines on Good Distribution Practice (GDP) were updated at the end of 2013. This post covers an overview of the main differences between GDP and Good Manufacturing Practice (GMP).
read more
GDP and GMP training courses
Interactive and thought provoking classroom and online GDP and GMP training courses facilitated and developed by Pharma experts with great training abilities
read more
GXP / GMP Consultancy
Global projects successfully undertaken for some of the largest Pharma businesses
read more
Curriculum Vitaes in Training Records
I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records. This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.
read more
Update to the EU’s Good Distribution Practice guidelines
The European Union’s GDP guidelines were updated on the 7th March 2013. This article is a simplified overview of the new GDP guidelines and features an opportunity to download a copy of the full Guide.
read more
Non-conformity – not following a procedure
A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy. This is a non-conformity, and should be raised as such. The problem is – what clause of the standard actually states that you should follow your procedures? On investigation this is not as easy to find as you might like to think!
read more
Pharma compliance training
Use Inspired Pharma to deliver your next Pharma compliance training programme deploying either our effective online learning courses, our GMP experts or use both for maximum impact
read more
Procedure or documented procedure?
In many standards that exist there are often statements such as “there must be a procedure to control training records”. Whilst I am sure that none of you will disagree with a statement such as this there is an element of unclarity in the statement itself. It surrounds the use of the word “procedure” and what is meant by a procedure.
read more
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
Use the tabs below, and above in the header, to select more articles on specific topics of interest
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
12 Good Manufacturing Practice
19 Sterile Products
25 Pharma GMP Lead Auditor Dublin, Ireland
September
10 Pharma GMP Lead Auditor
19 Documentation and Records
October
09 Data Integrity
10 Good Distribution Practice
17 Good Manufacturing Practice
November
05 Pharma GMP Lead Auditor Manchester, UK
13 Internal Auditor
20 Sterile Products
27 Problem Solving
December
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
Online courses available anytime anywhere
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
Useful Links
Audit
IRCA
QMS
EMA
Eudralex
MHRA
World Health Organisation
QP
Royal Pharmaceutical Society
Royal Society of Chemistry
Society of Biology
