Improving Global Compliance: A Successful Audit in Indore, India

Our expert consultants, Darren Jones and Philip Rose have returned from a successful on-site audit in Indore, India. Working alongside a highly skilled team, they exemplified EPiC Auditors Ltd’s unwavering commitment to delivering GXP auditing excellence worldwide.

During the rigorous audit, our consultants meticulously assessed critical elements of the sterility assurance operation, implementing robust auditing practices and identifying areas for improvement. Through close collaboration with the local team, they successfully strengthened regulatory compliance for the site which will undoubtedly enhance overall performance.

At EPiC Auditors Ltd, we specialise in providing comprehensive GXP auditing, consultancy, and training services to the pharmaceutical industry. Our mission is to improve and protect public health by ensuring global compliance and upholding the highest standards of patient safety.

Choose EPiC Auditors Ltd for superior solutions that significantly impact your organisation’s quality, compliance, and patient safety.

Contact us today to learn how our experts can support your success on a global scale.

Email: enquiries@epic-auditors.com

Global Compliance and the team in Indore

Agenda Announced for the EPiC Autumn Compliance Seminar

EPiC Autumn Compliance Seminar

With just over 3 weeks to go until the EPiC Autumn Pharma Compliance Seminar on Thursday 10th November 2022 we have released a copy of the whole day’s agenda.

Here’s a summary of what is covered:

  • Guest speaker Richard Parker, Senior GMDP Inspector at the MHRA will be delivering an MHRA update on Annex 1 with a regulators view of the changes.
  • Richard Andrews (EPiC & ex MHRA GMP Inspector & Unit Manager) will be your host for the day as well as giving an overview of recent updates to guidance & regulations and how to future proof your compliance.
  • Michelle Yeomans (EPiC Operations Manager and ex MHRA GMDP Inspectorate Unit Manager) will be reviewing the direction of travel for compliance and speaking to Louise Mawer (ex MHRA Inspector) about the implementation of the Clinical Trials Regulation and overcoming challenges at the IMP/GCP interface.
  • Darren Jones (EPiC & ex MHRA Inspector) will explain how to develop your PQS and move from remediation to sustainable compliance, as well as discussing current and future Annex 1 deficiencies and the  the pitfall to avoid.
  • Liz Allanson (EPiC & ex MHRA GMP Inspector) will give a presentation on points to consider when moving from an R&D to a GMP environment.
  • Guest speakers Gaynor Brummitt (SeerPharma UK & ex MHRA Senior GDP Inspector) & Shahbaz Sarwar (SeerPharma UK ex MHRA GDP Inspector) will be explaining Importation and the Role of the RPi.       
  • There will also be a Q&A session where a panel drawn from the speakers will answer questions submitted throughout the event.

Download the Agenda here:

The day promises to be of real interest to pharmaceutical industry professionals involved in the manufacture and supply of medicines and aims to;

  • Share recent changes and updates to the GMP and GDP Guidelines and Regulations with particular focus on Annex 1.
  • Highlight changes to inspection practices and MHRA oversight.
  • Discuss tools and practices to maintain compliance.
  • Present current and future Annex 1 deficiencies, along with the pitfalls to avoid.
  • Provide insight into the changes arising from the implementation of the Clinical Trials Regulations and points to consider around the IMP / GCP Interface.
  • Explore the challenges and considerations when moving from an R & D to a GMP Environment. 

How to secure your place

Tickets are now available to buy online and cost £250.00 + VAT

Click on the button below to register

Any booking enquiries, please email: enquiries@epic-auditors.com


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

EPiC Top Tips-Calibration

5 Top Tips for Calibration Success

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

calibration

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

ARE YOU HEADING FOR IAG?

Trust us: IAG is not an acronym that you want to be too familiar with. It stands for Inspection Action Group, the multidisciplinary team at the MHRA that determines whether your organisation maintains or loses its manufacturing or wholesale dealers licence.

It may be surprising to some of you that after 50 years plus of pharmaceutical legislation and GMP/GDP regulations that 3-4 companies a month still find themselves being referred to IAG with the potential of having their licences suspended or coming under strict and costly surveillance by the MHRA Compliance Management Team.

However, this is not so surprising to us in the EPIC Auditors team. Most of us are ex MHRA Inspectors, and we know only too well that any change in the Senior Management of a company can have a significant effect on the quality mindset and compliance level of a site.

Hopefully it will be for the better but sadly all too often it is for the worse. Most of the companies that we work with require our help because the quality focus at senior level is inadequate. It is still rare to see a Quality Director on the Board of Directors and this role should be seen as important as that of the Finance Director and Operations Director. If all Senior Management Teams had the Quality training and Quality understanding required to run the business in a cost effective and compliant manner, then we might see a reduction in Inspection Action Group cases at MHRA.

It is our opinion that anyone appointed to a Senior Management Team role should undergo mandatory training in Quality Management and ICH Q 10 principles.  Those companies that we have provided this training for will hopefully endorse our thinking. It is a requirement of GMP that all employees have training in Quality Management and this includes the Senior Management Team. Failures to implement an appropriate Pharmaceutical Quality System and to conduct suitable and effective quality management reviews with the involvement of senior management, feature in the top 10 deficiencies raised by MHRA year on year. Ensuring the Senior Management Team are aware of and are trained in their quality role and responsibilities, should lead to fewer companies facing the threat of IAG.

iag