News

Trust us: IAG is not an acronym that you want to be too familiar with. It stands for Inspection Action Group, the multidisciplinary team at the MHRA that determines whether your organisation maintains or loses its manufacturing or wholesale dealers licence.

It may be surprising to some of you that after 50 years plus of pharmaceutical legislation and GMP/GDP regulations that 3-4 companies a month still find themselves being referred to IAG with the potential of having their licences suspended or coming under strict and costly surveillance by the MHRA Compliance Management Team.

However, this is not so surprising to us in the EPIC Auditors team. Most of us are ex MHRA Inspectors, and we know only too well that any change in the Senior Management of a company can have a significant effect on the quality mindset and compliance level of a site.

Hopefully it will be for the better but sadly all too often it is for the worse. Most of the companies that we work with require our help because the quality focus at senior level is inadequate. It is still rare to see a Quality Director on the Board of Directors and this role should be seen as important as that of the Finance Director and Operations Director. If all Senior Management Teams had the Quality training and Quality understanding required to run the business in a cost effective and compliant manner, then we might see a reduction in Inspection Action Group cases at MHRA.

It is our opinion that anyone appointed to a Senior Management Team role should undergo mandatory training in Quality Management and ICH Q 10 principles.  Those companies that we have provided this training for will hopefully endorse our thinking. It is a requirement of GMP that all employees have training in Quality Management and this includes the Senior Management Team. Failures to implement an appropriate Pharmaceutical Quality System and to conduct suitable and effective quality management reviews with the involvement of senior management, feature in the top 10 deficiencies raised by MHRA year on year. Ensuring the Senior Management Team are aware of and are trained in their quality role and responsibilities, should lead to fewer companies facing the threat of IAG.

February 2021 is the date by when the 34 CEN nations (primarily Europe and Turkey) have to implement EN 17141:2020 as a national standard. This new Cleanroom standard and associated controlled environments – Biocontamination control standard, sets expectations for risk assessment, viable contamination control, viable monitoring methodology and monitoring frequency.

The new cleanroom standard applies to pharmaceutical, medical device, hospital/healthcare and food cleanrooms. EN 17141:2020 covering microbiological contamination sits nicely alongside the ISO 14644 series that relates to cleanroom non-viable contamination monitoring and classification.

What is a cleanroom?

A cleanroom is a controlled environment where pollutants like dust, airborne microbes, aerosol particles and chemical vapours are kept at specific levels to minimize contamination. These environments are used in industries such as pharmaceuticals, biotech, medical device and life sciences where small particles can adversely affect manufacturing processes.

In a cleanroom, the concentration of airborne particles is controlled to specified limits. To achieve this, the air in a cleanroom is repeatedly filtered through High Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filters to remove internally generated contaminants.

Cleanrooms are classified based on the cleanliness level of the air inside them. This classification is determined by the number and size of particles permitted per volume of air. For example, no more than 100 particles (0.5 microns or larger) per cubic foot of air.

Associated controlled environments are areas adjacent to or within the cleanroom that also have controlled levels of contamination. These areas may include gowning rooms, pass-throughs, and material airlocks. They play a crucial role in preventing the ingress of contamination into the cleanroom.

The new Biocontamination control standard sets expectations for risk assessment, viable contamination control, viable monitoring methodology and monitoring frequency in these controlled environments. It aims to ensure that cleanrooms and their associated controlled environments maintain the necessary cleanliness levels to prevent product contamination, thereby ensuring quality and safety.

We are very pleased to announce that Peter Coombs and Claire Glenister have recently joined the EPIC Auditors team. This will bring the number of Ex MHRA Inspectors working with EPIC Auditors to fourteen.

With access to such a wide range of knowledge and experience, we are confident that we can provide GXP support throughout the medicinal product lifecycle and help all our clients to improve their GXP quality systems and regulatory compliance.

If you need our help and support then please don’t hesitate to contact us.

Telephone Number: +44 (0)1244 980544

During the Covid 19 pandemic, like the MHRA, and like many other businesses, EPIC Auditors has been providing remote pharmaceutical audits and support.  Helping companies to meet the regulatory requirements and to develop the quality systems essential to support much needed clinical trials for various Covid 19 treatments.  

As part of this facilitation work, EPIC have developed a set of generic SOPs for key elements of the quality system that companies can then adapt to their own business framework and style. We now have a set of 10 SOPs covering:-

• Quality Management Reviews
• Deviations
• CAPA
• Complaints
• Recall
• Change Control
• Quality Risk Management
• Documentation
• Self – Inspection
• Supplier Evaluation

You can purchase this set of SOPs for £2700 by contacting:   enquiries@epic-auditors.com

We also have a  set of SOPs specifically for manufacturers of IMPs covering:

• Importation of IMPs
• Batch Certification
• Reference & Retained samples for IMPs
• Complaints
• Recall

Please let us know if you are interested in remote audits and support, using the same e mail address.

In addition to providing support for Covid trials, we have also adapted to providing routine remote pharmaceutical audits of all kinds including internal audits and supplier audits as well as mock MHRA inspections. Advances in technology are helping us to overcome the challenges of remote auditing but it is likely that the efforts will not be wasted, as remote auditing is probably going to be with us for some years to come.

If you need our help and support then please contact us on  +44 (0)1244  980544

or email us at:  enquiries@epic-auditors.com