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The benefits of being IRCA registered

Our 5-day Pharmaceutical GMP Auditor/Lead Auditor Course is registered with IRCA, the International Register of Certificated Auditors (IRCA Ref:PR325).  This is the world’s premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses.

Raising non-conformities

Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit.  This is somewhat of an old-fashioned way of auditing.This article the best way of dealing with non-compliances using modern standards.

Documents required by USA GMP (21 CFR 211)

The article covers the requirement of written procedures required by 21 CFR 211

Documents required by EU GMP

The list below details the documented procedures specified as being required by EU GMP. It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.

The Focus of Audits – Have we got it right?

The focus of audits : as a pharmaceutical trainer, auditor and consultant I meet a lot of auditors and look at audit mechanisms a great deal. My impression is that the focus is not always right.

GMP Auditing Articles and News

Read our articles on GMP auditing relating to regulatory compliance in the Pharma industry . The 5 most recent articles are shown in the slider and the rest are shown in date order below.

Management Review – who, what, where and when?

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

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?

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?

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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New course on Data Integrity

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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Curriculum Vitaes in Training Records

Curriculum Vitaes in Training Records

I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records.  This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.

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Auditing abroad

Auditing abroad

A new challenge for all auditors – being asked to perform an audit in a foreign country, where you don’t speak the local language! How should this be tackled?

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Good auditing techniques

Good auditing techniques

When people talk about good auditing technique it is easy to immediately start covering how to ask questions, how to deal with people and how to make notes.  Whilst this is all true, it is easy to forget that there are 4 stages to the audit process and good auditing technique can be used at all of these stages – as we will see.  This makes for a better audit.

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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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Our Public Course range

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 began to once again offer traditional classroom courses - see details on each course page.

Click on course name for full course details and dates:

Pharmaceutical GMP Auditor/Lead Auditor

Advanced Good Manufacturing Practice

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

Webinar: Microbiological control in pharmaceutical production 

QP Courses - full range

See and download our Auditing Brochure detailing our courses and services in this important area.

Online courses available anytime anywhere 

Data Integrity

Good Distribution Practice (GDP)

Good Manufacturing Practice (GMP)

Pharma Quality Management Systems module

QP Medicinal Chemistry & Therapeutics module 

QP Quality Management Systems module

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.

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