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

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’.

Another ex MHRA Inspector Joins the EPiC Team

EPIC Auditors is very pleased to announce that Ex MHRA Inspector Michelle Yeomans will be joining us on 7^th April to fulfil the role of EPIC Auditors Operations Manager. 

EPIC Auditors was established in 2014 by Liz Allanson and Darren Jones (both ex MHRA) to fulfil the increasing need for ex MHRA Inspectors to conduct mock regulatory inspections and to provide consultancy advice from the Regulatory perspective. The company has developed considerably over the last 8 years and Michelle has been appointed to further strengthen the management team and assist with the day to day operation of the business.

Michelle is well known to the pharmaceutical industry having been in the MHRA GMP/GDP management team for many years and been a familiar face at many MHRA GMP/GDP and GCP Symposia.  Michelle has completed 17 years in the MHRA starting as a GCP Inspector, progressing to Senior Inspector and gaining accreditation for GMP inspections of manufacturers of clinical trials, before moving to become a GMDP Operations Manager and ultimately the GMDP Inspectorate Unit Manager.

Michelle brings to EPiC not only the considerable length of service in the MHRA, at both Senior Inspector and senior management level, but also excellent organisational skills, and 19 years previous experience working and auditing in the pharmaceutical industry.  Michelle held positions in Technical and QA roles with various pharmaceutical companies and operated as an IMP Transitional QP prior to joining the MHRA.

Over the years Michelle has engaged extensively with the industry and we are sure this will continue as she works with our clients to help them to improve their GXP quality systems and regulatory compliance.

We are really excited about Michelle joining our team, and acknowledge the skills that she will bring to improving our own quality systems as well as those of our clients.

You can read more about Michelle’s background and qualifications as well as meet the rest of the EPiC Auditors Team here: Meet The Team

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