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.
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.
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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.
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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?
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2018 course dates
Details of our scheduled public course dates for 2018
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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.
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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
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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.
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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
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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
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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.
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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.
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Forthcoming Public Courses
October
09 Data Integrity
17 Good Manufacturing Practice
November
05 Pharma GMP Lead Auditor Manchester, UK
13 Internal Auditor
20 Sterile Products
27 Problem Solving
December
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
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