GXP Compliance Challenges

The constantly evolving landscape within the pharmaceutical industry presents a myriad of challenges, especially when it comes to compliance. Across the GXP’s the range of compliance areas is vast and varied.

Your experiences and insights are invaluable to us, as they help us customise our services to better address the real-world challenges you face. Your feedback will shape our future symposia, articles and top tips, ensuring we focus on the areas that will most benefit your operation.

Please let us know which aspects of regulatory compliance you find most challenging and why and share your thoughts and ideas about the compliance hurdles that have the greatest impact on your business.

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 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.”  

At EPiC, post-inspection remediation is a core element of our GXP compliance consultancy service. Many of EPiCs consultants have experience of MHRA Compliance Management team (CMT) and Inspection Action Group (IAG) processes, gained working within the MHRA and also outside as consultants. EPiC auditors regularly support companies who have been referred to CMT or IAG , leading root cause analysis workshops, advising on the response to the inspection findings, developing remediation plans and assisting with implementation. In a number of cases, EPiC have also provided assessment of compliance improvement following MIA suspension which have led to reinspection by MHRA and lifting of the suspension.

In response to the recent MHRA Inspectorate Blog post, which can be found here: Compliance Monitor process (Part 1) – An introduction

Richard Andrews commented ‘Based on our extensive experience to date, EPiC fully supports MHRA’s plan to further evolve it’s risk-based inspection practices with the launch of the compliance monitor process, which will see the MHRA begin a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors. EPiC intend to apply to be named on the register of compliance monitors and eagerly awaits the publication of the second part of MHRA’s compliance monitor process blog, which is expected to provide more details on the Compliance Monitor role and application process’.