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.
Design Criteria for an Effective QMS
Most of you will already have a QMS that has already been designed so the contents of this video will help you to consider how you can evolve an existing QMS to cope with new regulatory requirements, QMS ideas and business pressures. In this video we begin to examine...
The Concept of Quality and Quality Definitions
This article will consider the concept of “quality” and looks at how a range of experts in this field have arrived at various quality definitions.
The Concepts behind Modern QMS Thinking
In this article and video we look at some general systems thinking points and consider the structure of a Quality Management System together with the underlying concept of Quality Management principles – the “oil” used to maintain our Quality Management System. Taken from Unit 01 Chapter 03 of our QPharma/QP course on Quality Management Systems
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.
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.
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.
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
About Inspired Pharma
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2020
11 Good Manufacturing Practice
March
2 Pharma GMP Lead Auditor Japan
24 Advanced Good Manufacturing Practice
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