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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.

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.

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

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.

QMS News and Articles

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

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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.

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Auditing abroad

A new challenge for all auditors – being asked to perform an audit in a foreign country, where you don’t speak the local language! How should this be tackled?

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About Inspired Pharma

We help people in pharma organisations to continually improve their systems to gain competitive advantage and ensure regulatory 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

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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

03 Pharma GMP Lead Auditor

All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.

Online courses available anytime anywhere

Data Integrity

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.

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