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.
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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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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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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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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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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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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Update to EU GMP Chapter 8 – Complaints, Quality Defects and Product Recalls
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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Update to EU GMP Chapter 5 – Production
Chapter 5 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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Update to EU GMP Chapter 3 – Premises and Equipment
Chapter 3 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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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.
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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
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