GMP News and Articles
Read our articles on pharmaceutical GMP regulatory developments as well as news about our pharmaceutical training courses. The 5 most recent GMP news articles are shown in the slider and the rest are shown in date order below.
If you have some GMP news you would like us to publish then please contact us.
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.
Annex 1 2022 Section 3: Pharmaceutical Quality System
This article explores Annex 1 Section 3, the Pharmaceutical Quality System highlighting requirements beyond those in EU GMP chapter 1.
Annex 1 2022 Section 2: Principle
In the last article, I discussed the scope of the latest update to Annex 1. In this article I want to focus on section 2, “Principle”.
Annex 1 2022 Section 1: Scope
In the first article I summarised the background to the latest update to Annex 1. In this article I want to focus on sections 1, “Scope”.
Annex 1 2022 Introduction and background to the update
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to...
Do QC labs work to GLP?
This is a commonly asked question on my training courses which is generally misunderstood. Quality Control (QC) laboratories that are based at classic pharmaceutical manufacturing sites DO NOT work to GLP.
Raising non-conformities
Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit. This is somewhat of an old-fashioned way of auditing.This article the best way of dealing with non-compliances using modern standards.
History of the Orange Guide
This article provides a brief overview of the history of this book and also covers why it is certainly no longer a guide.
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:
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 will also begin to offer some 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
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.