EPiC’s Autumn Compliance Seminar

Registrations are now open for EPiC’s Autumn Compliance Seminar:

Thursday 10th November 2022

compliant future

Shaping a Pharma Compliant Future

After the success of our GMP Symposium in February, EPiC Auditors are pleased to announce that we will be delivering a virtual compliance seminar on Thursday 10th November 2022.

The theme is Shaping a Pharma Compliant Future – How to achieve and demonstrate sustainable compliance.

This online seminar 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!

The outline agenda includes;

  • Recent Updates to Guidelines and Regulations
  • Assessing and Demonstrating Compliance
  • Tools to maintain compliance
  • Current and future Annex 1 deficiencies
  • The IMP/GCP interface
  • Future-proofing compliance
  • Considerations when moving from R&D to GMP
  • GDP controls and expectations for importation

**Re-visit our website here to see the full the details and agenda as it develops**

You can now buy your EPiC Autumn Compliance seminar tickets for £250 + VAT

Click on the button below to register and pay online:


In collaboration with SeerPharma UK

pharma compliant future

You may also be interested in the SeerPharma UK GDP Symposium taking place on Tuesday 8th November 2022: Register and Pay Online Here

SAVE THE DATE: EPiC Auditors Autumn Compliance Seminar

Autumn compliance seminar

EPiC Auditors are excited to announce that they will be delivering an Autumn Compliance Seminar on 10th November 2022 focusing on shaping a compliant future.

This will be an online event. Further details about the speakers and agenda will be published on this page over the coming weeks.

This event has already taken place. What was the event about?

The online seminar, delivered remotely over a complete day, featured a diverse lineup of ex-MHRA Inspector speakers. Among them was Richard Parker, Senior GMDP Inspector at MHRA, who provided an update on Annex 1 from a regulator’s perspective. The day was filled with insightful and thought-provoking discussions aiming to:

  • Disseminate updates and recent changes in GMP and GDP Guidelines and Regulations, especially Annex 1.
  • Illuminate alterations in inspection practices and MHRA oversight.
  • Delve into tools and strategies for maintaining compliance.
  • Reveal current and future deficiencies in Annex 1, along with pitfalls to steer clear from.
  • Offer insights into changes resulting from the Clinical Trials Regulations implementation and points to contemplate about the IMP / GCP Interface.
  • Examine the challenges and considerations during the transition from an R&D to a GMP Environment.

The seminar offered updates and information regarding recent amendments to guidelines and regulations, as well as insights into current deficiency trends and inspection practices.

MHRA Compliance Monitor Process (Part 2)

MHRA Inspectorate Blog has recently published Part 2 in the Compliance Monitor Process series with further information about the Compliance Monitor (CM) role and application process.

The blog can be found here: Compliance Monitor Process (Part 2)– CM role and application process

The blog acknowledges that it is common for companies that are at IAG to employ consultants to assist with remediation activities, and this is something that EPiC has extensive experience of supporting including reporting on progress to MHRA. The application process for an individual to apply for the CM pilot programme to be named on a register will be based on an eligibility assessment by MHRA considering career history, relevant experience, not having been personally the subject of MHRA regulatory action and/or significant adverse findings in the previous 3 years, and the need to have completed relevant training in the CM process. Eligible CM’s will then be assessed by MHRA for suitability on a case-by-case basis when they are nominated by a company, to confirm that they have sufficient experience of the dosage forms and site operations and that there is no conflict of interest. 

In response to the recent MHRA Inspectorate Blog post, Richard Andrews commented “It is good to see that both eligibility and suitability of the CM are being assessed which draws parallels from the naming of Qualified Persons (QPs) on UK manufacturing licences. Although a QPs eligibility to be named may be assessed by the Joint Professional Bodies, MHRA, or an EU regulator, their suitability to be named on a specific UK manufacturing licence is assessed and decided by MHRA based on site-specific knowledge and experience, which is above and beyond their eligibility assessment. The same two-stage approach will help to ensure CMs will have the background experience and site-specific knowledge to assess risks to product quality and patients in developing and overseeing remediation plans and assisting with implementation. This type of remediation work is a core service we offer at EPiC and is why our consultants will be applying to be named as CMs.”  

Compliance monitoring

MHRA Speaker Confirmed

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

MHRA

DOES YOUR CLEANROOM MEET THE NEW STANDARD?

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.

cleanroom