I was delighted to host and run another of our hugely successful GMP courses to a full house from 16 to 19 May in Manchester.

Overall the course feedback was a very reassuring average 4.5/5.

The delivery team were delighted by the many positive comments from delegates both in writing and verbally during the course and are also pleased to receive the constructive criticism for continual improvement. This is a large subject and the feedback ranged from those who wanted more detail to those who thought it was pretty complex with most happily somewhere in between. Although targeted to those in their first 5 years’ experience in the group ranged from those in their first month in the industry to some with up to 15 years’ experience!

The GMP quiz at the end of the course was good fun and had some great teamwork, and although very close there was a clear winning team with some special souvenir pens as prizes. In addition the challenge to come up with new definitions for “GMP” worked well and went with the theme of patient protection.

Several delegates asked at the end of the course what more they could do to continuing this training in the years ahead.  I would whole heartily recommend specialist training in skill areas to support auditing and self-inspections. (this GMP training is a useful entry to our auditor training courses) Auditing is a great area of focus for the future and is a great learning ground. In addition for those hungry for more detail then I would recommend the Qualified Person and Continual professional development training course whether or not you wish to become a QP, it can lead to Post Graduate qualifications in “Pharmaceutical Quality and GMP” at Certificate , Diploma or MSc level.

A couple of people did comment that the wish the course was run in Amsterdam, it is! And will run there again on 28 November. We are also planning to run it in Istanbul next year so watch the website for details of this and other courses.

Throughout the course the focus was on protecting the patient and protecting the company and to use knowledge of GMP and the legislation to ensure both these objectives are met.

Mike Halliday

NSF-DBA Partner

The MHRA has launched its new Notification Scheme for clinical trials today (1 April 2025) for medicinal products.

The Notification Scheme is available for trials involving medicinal products authorised in any EU Member State if:

•  they relate to the licensed range of indications, dosage and form
• or, they involve off-label use (such as in paediatrics and oncology, etc) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines.

The Notification Scheme will be open to trials meeting the above criteria and may include randomisation of subjects to different marketed products or repackaging and/or relabelling of the marketed product(s). Placebo controlled trials will not be open to the notification scheme, nor will trials in which the marketed product has been modified, for example by over-encapsulation.

Following receipt of a valid notification submission, sponsors will receive an acknowledgement letter to say that the trial may go ahead after 14 days from receipt of the notification, if the MHRA has not raised any objections. This means that the acknowledgement letter will act as the authorisation.

 If the MHRA raises an objection to the notification, the submission is treated as a standard request for authorisation and an assessment is carried out in the usual way with a time line of 30 days from the receipt of the original notification.

A risk assessment based on the potential risks associated with the use of the investigational medicinal product (IMP) should be made by the sponsor. Background documentation on how to do this is provided on the web site in the new section on the Notification Scheme.

This is the first part of the Medical Research Council (MRC) / Department of Health (DH) / MHRA Joint Project on Risk Adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products.

The second part of the project will provide guidance on risk-proportionate approaches to the management and monitoring of clinical trials. This will be available following the completion of the currently on-going pilot phase.

Pete Gough, 

NSF-DBA Ltd.

There is a proposal for a new general chapter in the European Pharmacopoeia - Demonstration of Uniformity of Dosage Units (UDU) using large sample sizes (see attached).

 In order to take advantage of increased batch control offered by process analytical technology (PAT) tools, for example large sample sizes used for the control of uniformity of dosage units, a new Ph. Eur. general chapter 2.9.47 is proposed. Comments on the proposed general chapter should be submitted by 30 June 2011.

The document can be found at the following site:  http://www.edqm.eu/medias/fichiers/Enquiry_Demonstration_of_Uniformity_of_Dosage_Unit.pdf

Pete Gough

NSF-DBA Ltd.

"NSF-DBA's course on Human Error:Causes and Prevention helped us to reduce errors and repeat deviations by 51% in the 8 months after the course"

"NSF-DBA are the "go to" consultants for error reduction in the pharmacuetical industry"

"Error reduction is possible and NSF-DBA's course shows you how" 

These are just a sample of the comments from statisfied delegates who attended our course on 'Human Error:Causes and Prevention'. If you are interested in 

• Error proofing your proecesses
• Simplifying your systems to reduce errors
• Identifying and removing the 'root cause' of human error
• Reducing errors by improving decision making