GMP News and Articles
Read our articles on GMP regulatory developments as well as news about our pharmaceutical training courses. The 5 most recent GMP articles are shown in the slider and the rest are shown in date order below.
Standards to use when auditing suppliers
If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. GMP does not really tell you what pharmaceutical supplier standards you should or could use when auditing your suppliers this post lists of all the key standards to use when auditing suppliers including links to all of the key documents and authorities.
read more
EU GMP Chapter 9: Self-Inspection – time for an update?
In the past few years eight of the nine chapters of EU GMP have been updated. However, Chapter 9 has not been updated at all. This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too? Here are my thoughts
read more
Data Integrity – why all the fuss?
The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.
read more
Problems and deviations – avoid blaming the operator
You should be careful of putting “human error” as the cause of a problem, without considering what caused the human to make the error in the first place
read more
Launch of short on-line GMP course
Now available – a 1-hour on-line course designed to introduce people new to the pharmaceutical industry to the main requirements of Good Manufacturing Practice with versions for Warehouse, Packaging and Manufacturing personnel
read more
Key GMP personnel and their duties
Some of the most popular articles on our blog are the four we published some four years ago about the duties of key personnel in GMP. For more recent visitors to the blog I thought it might be helpful to remind everyone about this resource.
read more
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
Update to EU GMP Chapter 8 – Complaints, Quality Defects and Product Recalls
Chapter 8 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.
read more
Update to EU GMP Chapter 5 – Production
Chapter 5 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.
read more
Update to EU GMP Chapter 3 – Premises and Equipment
Chapter 3 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.
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
November
13 Internal Auditor
20 Sterile Products
27 Problem Solving
December
03 Pharma GMP Lead Auditor Now Full
January 2019
Febuary 2019
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
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
