Category News

EPIC Auditors are delighted to announce that ex MHRA Inspector Stephen Grayson has joined the team as an independent consultant.

Stephen has over 39 year’s pharmaceutical industry experience in manufacture, packaging, auditing and inspection, fourteen spent working for the MHRA, where he held the post of Senior GMDP Inspector. He is widely known across the industry and has extensive experience of GMP inspections, having completed more than 500 in the UK and over 300 in third countries.

Stephen was trained and accredited by the MHRA to inspect:

• Collection, processing, testing and distribution of blood and blood components
• Sterile and non-Sterile manufacturing sites (all dosage forms).
• NHS and commercial “Specials” manufacture, including sterile product.
• Sterilisation processes including irradiation, ethylene oxide, moist heat and dry heat.
• Sterile API manufacture.
• Wholesale dealers (storage and distribution).

With his comprehensive portfolio of pharma compliance experience, Stephen is an excellent addition to the EPIC team. We are confident we can provide you with GXP support across the medicinal product lifecycle and help all our clients improve their GXP quality systems and regulatory compliance.

Pharmaceutical Industry Experts

Auditors used by EPIC are former Regulatory Inspectors, typically ex MHRA Inspectors. All auditors have extensive industry experience and many years of experience auditing and inspecting within the pharmaceutical industry.

To read the bio and full CV for Stephen and our other experts’ visit Meet Our Experts

We are very pleased to announce that Michelle Yeomans, GMDP Inspectorate Unit Manager at the MHRA will be delivering a Regulatory Update at the forthcoming GMP symposium.

Michelle will be covering the Clinical Trials Regulation and what it means to the UK, share the latest on the NI Protocol and the discussions with the EU, give an update on the transformation of the agency and highlight the top 10 deficiencies arising from GMP Inspections during 2021.

On receiving confirmation of Michelle’s participation Richard Andrews, EPIC Auditors Managing Director commented ‘we are extremely privileged to have somebody of Michelle’s standing and experience to present at the symposium. It offers a real opportunity for all delegates to receive the most current information on the changes facing the industry.’

This virtual pharma compliance conference will be a full day delivered remotely and is ideal for pharmaceutical industry professionals in quality control, quality assurance, supply chain and production management, as well as Qualified Persons, regulatory and compliance specialists involved in the manufacturing of medicines. 

The event will provide the latest information and guidance on changing legislation and give you insight into what you might have missed since the start of the pandemic. 

To find out more and to book your place follow the link here

We at EPiC Auditors Ltd will be running our very first virtual GMP pharma compliance conference on Tuesday 1st February 2022. The theme is Back to the Present; an opportunity to see what you’ve missed during the pandemic and what’s on the horizon.

This virtual GMP symposium will be a full day delivered remotely comprising a variety of ex MHRA Inspector speakers with an invited guest MHRA GMDP Inspectorate speaker. Altogether it will be a thought-provoking and informative day, with a few laughs along the way.

The EPiC GMP pharma compliance conference is ideal for pharmaceutical industry professionals in quality control, quality assurance, supply chain and production management, as well as Qualified Persons, regulatory and compliance specialists involved in the manufacturing of medicines.

The day will provide you with the latest information and guidance on changing legislation and give you insight into what you might have missed since the start of the pandemic. Through presentations on current deficiency trends and an IAG case study, you will learn how to maintain a compliant PQS and better manage remote inspections.

Richard Andrews, Managing Director and Senior Consultant for EPiC says, “We are really excited to be delivering this symposium and to be sharing the collective knowledge of the ex-MHRA Inspectors working for EPiC Auditors. The regulations, guidance and expectations are continually evolving and companies need to ensure they stay up to date to remain compliant.”

Tickets cost £250.00 and include Multi-attendee discounts – book one place at the full price and book up to three further places at the same time at a 50% discount.

This event is brought to you in collaboration with SeerPharma UK

To buy tickets follow the link below.

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