For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 [email protected]

Some of our most popular articles

For some week-end reading!

Our most read articles in 2019

These are the 5 most popular articles on our website in 2019

The Golden Rules of GMP – a free GMP video

This free GMP video lasts less than 2 minutes and you can download it for your personal use OR as a part of any refresher/compliance training programme you are running in your organisation providing you leave the opening and closing credits part of the video.

A Quality Manual – what is it and what should it contain?

A Quality Manual is a very useful document that not only gives guidance and direction to an organisation’s own personnel, but gives a potential customer, inspector or auditor an appreciation of an organisation from the outside. If designed well it can be used as a tool to sell an organisation, to show what a positive quality ethos they have and can show how good an organisation is and how seriously it takes its Quality Management System.

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?

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.

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).

Our series of articles on the key roles in GMP have proven very popular

These articles were written over the last 5 years but are constantly referenced today too

The roles of the Heads of Production & QC and the Qualified Person

In this video, we look at “The roles of the Heads of Production & QC and the Qualified Person” and what GMP’s requirements are when it comes to roles and responsibilities as well as the specific duties of these three individuals.

The positioning of the Qualified Person (QP) within the organisation

In previous posts we have looked at the Roles and Responsibilities of the 3 Key Personnel required by EU GMP, namely the Head of Production, the Head of Quality Control (QC) and the Qualified Person (QP).  In this post we look at the organisation of these people within the business. 

Duties of key personnel in GMP – Part 4 (Human Resources)

In a number of GMP courses that I have presented in the past we have looked at what the delegates think the Human Resources Manager’s role should be, bearing in mind the role is not formally defined in EU GMP. Their findings are detailed in this post.

Duties of key personnel in GMP – Part 3 (Engineering)

From Parts 1 and 2 of this post we highlighted that there is no formal need for an Engineering Manager or Department in GMP. In the manufacture of medicines the equipment used and the environment it is located in has a massive impact on product quality. The role of the Engineering Manager is therefore critical.

Duties of key personnel in GMP – Part 2 (Quality Assurance)

From Part 1 of this post we highlighted that there is no formal need for a QA Manager or Department in GMP.  EU GMP does require you to have a QA system, but there is no mention of who should manage...

Duties of key personnel in GMP – Part 1 (Production, QC and the QP)

Duties of key personnel in GMP – Part 1 (Production, QC and the QP)Three key personnel are named on a pharmaceutical manufacturing site’s Manufacturing Licence.  These are the Head of Production,...

Our most popular articles on auditing

 

Planning to perform audits

As with everything else in life, planning is everything. An audit is much more effective for everyone concerned if the auditor takes a short amount of time to plan the audit correctly. This article incudes a checklistlist of things to include in the planning of any effective audit.

Auditing closing meeting template

Here is a free template for things that you should include in an auditing closing meeting

Auditing opening meeting template

Here is a free template for things that you should include in an auditing opening meeting

Good auditing techniques

When people talk about good auditing technique it is easy to immediately start covering how to ask questions, how to deal with people and how to make notes.  Whilst this is all true, it is easy to forget that there are 4 stages to the audit process and good auditing technique can be used at all of these stages – as we will see.  This makes for a better audit.

Related Articles

Find out about our course ranges

GMP Training

 

QMS Training

 

GDP/RP Training

 

GMP Compliance

 

QP Training

 

GDP Compliance

 

Subscribe

 Why not subscribe  to our mailing list to receive new articles posted to this site and try a free Taster of our online courses to see if they are of interest?