GMP Auditing Articles and News
Read our articles on GMP auditing relating to regulatory compliance in the Pharma
No matter what type of audit you are involved in it is essential that it starts and finishes well. Opening and closing meetings offer the forum to do this. A well run and professional opening meeting sets the scene for the audit and, if done well, creates a great first impression. Likewise, a well run closing meeting draws the audit to a close in a professional and controlled manner.
This article lists a number of common basic audit findings and the corresponding clause in EU GMP that is relevant. Readers should note that there is often some repetition in GMP, so I have tried to find the best single clause.
News Update – traditional classes to complement our ‘live online interactive’ format; new January date for Lead Auditor course; new versions of our online courses.
All of our training courses are now being delivered using our ‘live online interactive” format. Making the transition away from classroom delivery has been challenging especially for the team delivering our highly successful and intensive 5-day Pharmaceutical GMP Lead Auditor course. But the reviews in this article show how we have risen to that challenge.
In this article we explore the controls needed to both approve Pharma suppliers and to control the purchasing of materials from them
We successfully delivered our highly praised GMP Auditor/ lead Auditor training course in Osaka, Japan, for the third time a few weeks ago. The course will be presented again in Osaka next year in early March 2020
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...
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 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.
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.
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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Most of our public courses are currently being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together. In 2022 we will also begin to offer some traditional classroom courses - see details on each course page.
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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.