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 to include in an audit report
An audit report is an essential part of the audit and this article lists the key items that you should ensure are in your audit report contents.
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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.
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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.
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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 role in meeting the expectations of EU Inspectors (such as the UK’s...
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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.
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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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2019 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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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
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Quick Links
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Forthcoming Public Courses
March
4 Pharma GMP Lead Auditor Osaka, Japan
13 GMP Documentation and Records
14 Good Manufacturing Practice
18 Pharma GMP Lead Auditor
26 Responsible Person
April
May
13 Pharma GMP Lead Auditor Central London, UK
21 Data Integrity
June
4 Pharma Internal Auditor
6 Pharma Problem Solving
11 Responsible Person
13 Good Manufacturing Practice
18 Sterile Products
24 Pharma GMP Lead Auditor Dublin, Ireland
All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.
For all 2019 dates select the green 'See all Courses and Dates' button above or to the left.
Online courses available anytime anywhere
Good Distribution Practice (GDP)
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Pharma Quality Management Systems module
QP Medicinal Chemistry & Therapeutics module
QP Quality Management Systems module
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