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 symposium 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

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 Cleanrooms and associated controlled environments – Biocontamination control standard, sets expectations for risk assessment, viable contamination control, viable monitoring methodology and monitoring frequency.

The new 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.