Ensure your team understand the importance of Data Integrity

Now Available - online Data Integrity training for your team Our 20-minute online Data Integrity training course will ensure your entire team understand the importance of Data Integrity and their...

New EU GMP Directive published

The European Union has published its new Directive for pharmaceutical manufacturing sites that is to replace the existing Directive (Directive 2003/94/EC) for human medicines. From having an initial look at the new Directive, here are a few comments.

What Pharma Companies Need to Know about Measuring Instrument Calibration

According to pharmaceutical cGMP (current Good Manufacturing Practice) guidelines, pharma companies need to conduct regular instrument calibration as part of their validation and qualification activities. This article gives an overview of what is involved.

Must, Shall and Should – the use of these words in GMP

What is the difference in meaning between these words in the context of GMP?, In this post I explain, using EU GMP as my point of reference, although as you will find out, there are occasions within EU GMP where the incorrect terms have been used.

Management Review – who, what, where and when?

The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so. In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real shame. So what are these GMP Management Review meetings, why do we have them, what should be discussed, who should attend and how often should we have them?

Pharma News and Articles

Read our articles on pharmaceutical regulatory developments as well as news about our pharmaceutical training courses. The 5 most recent pharma articles are shown in the slider and the rest are shown in date order below.

GMP News and articles

QMS news and articles

2018 course dates

Jul 20, 2016 | 0 Comments

Details of our scheduled public course dates for 2018

Standards to use when auditing suppliers

Jul 4, 2016 | 0 Comments

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.

EU GMP Chapter 9: Self-Inspection – time for an update?

Jun 27, 2016 | 0 Comments

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

Data Integrity – why all the fuss?

Jun 20, 2016 | 2 Comments

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.

Problems and deviations – avoid blaming the operator

Jun 13, 2016 | 1 Comment

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

Launch of short on-line GMP course

May 25, 2016 | 0 Comments

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

Key GMP personnel and their duties

Mar 10, 2016 | 0 Comments

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.

Launch of short on-line GDP course

Oct 9, 2015 | 0 Comments

This one-hour course is designed to provide people new to the pharmaceutical industry with an appreciation of the main requirements of Good Distribution Practice and/or for refresher/compliance training.

New course on Data Integrity

Jul 16, 2015 | 0 Comments

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.

Update to EU GMP Chapter 8 – Complaints, Quality Defects and Product Recalls

Jun 9, 2015 | 1 Comment

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.

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