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

Thursday 10th November 2022

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

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

5 Top Tips for Calibration Success

Article By Darren Jones, Director & Senior Consultant for EPiC Auditors

Calibration is an often-overlooked area of the PQS; many calibration certificates are incorrect or don’t contain adequate detail and in many cases are not understood by the site experts!

Calibration services are frequently outsourced and I often find that key GMP decisions have also been inappropriately outsourced as well! Does the calibration company set the limits? Who determines how and when out of specification results are reported?

Many certificates do not state Pass or Fail… Why not? The certificates often just contain the limits and the data. I regularly find calibration results that do not comply with the limits- the calculations have not been done and no one in the Pharma company has checked the data!

Limits are sometimes specified as +/-2% of FSD (full scale deflection). What does this mean? Often the method of calculating this is not clear and the calculations used to determine this limit are not recorded or checked.

Given accurate instrumentation is key to achieving process control, which ultimately assures product quality, calibration requirements need to be understood and properly managed.

Tips for success:

1. Use multi-point calibration over the working range of the instrument.
2. Ensure you set, or at least approve the limits applied during calibration, don’t leave this just to the contractor.
3. Have a contract with the provider that includes instruments, frequency, limits, ranges and out of specification results reporting. Appendices containing tables can be useful to manage the detailed information.
4. Ensure results are reported as found and as left, i.e. pre and post any adjustment, you don’t want to miss a failed as found result.
5. Ensure limits are clearly understood. The SOP should show how to calculate limits e.g. based on FSD and these calculations should be documented and checked as per any other important calculation.  Evaluate the limits using Pass/Fail criteria.

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

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com

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.

EPiC Auditors Awarded Top 5 Quality Assurance Services Companies in the UK

We are delighted to announce that EPiC Auditors have won a place in Pharma Tech Outlook’s Top 5 Quality Assurance Services Companies in the UK 2022, the annual listing of 5 companies in the UK that are at the forefront of providing Quality Assurance services and transforming businesses in the region.

Specialising in performing mock inspections, GXP audits, supply chain and system audits, delivering bespoke training and supporting post-inspection remediation EPiC Auditors help clients achieve and maintain regulatory compliance.

Comprising of an experienced group of ex-MHRA Inspectors, the EPiC management team and consultants fully understand clients’ diverse needs and can therefore advise the best course of action to address the challenges they face and make their operations compliant with MHRA and EU regulations and guidelines by providing comprehensive GXP consultancy service.

As ex MHRA inspectors, EPiC Auditors is able to bridge the gap between pharmaceutical companies and the regulatory bodies, making us ideally placed to provide the knowledge, skills and expertise to drive sustainable compliance across the UK and Europe’s pharmaceutical and biotechnology industries.

You can access the Pharma Tech Outlook Magazine Quality Assurance Edition and read the full feature article here: https://www.pharmatechoutlook.com/magazines/May2022/Quality_Assurance_Europe/?digitalmagazine

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.”