Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Inspections and Audits
Inspections and Audits – an Introduction
Self-Inspection Audits, External Audits and Regulatory Inspections are crucial to finding whether there are any deviations, deficiencies, risks, or failures (or potential ones) within your company’s and your supplier’s operations, equipment or documents/records, as well as identifying whether your personnel involved in GDP activities understand how to be GDP compliant.
Once deviations, deficiencies, risks or failures they have been identified, you must start the process of planning and implementing corrective and preventive actions (CAPA) to correct/prevent these problems and provide reassurances to the inspectorate that your organisation and entrusted suppliers are compliant with GDP guidelines and Human Medicines Regulations 2012.
Self-Inspections (also referred to as ‘Internal Audits’ or ‘1st Party Audits’)
Performing a Self-Inspection regularly is a requirement for compliance with the EU Guidelines on GDP.
However, MHRA inspectors have often found that they are not carried out effectively or at all in some cases – which will be a marked as a ‘deficiency’. We recommend that ‘regular’ means that a self-inspection of your entire Quality Management System is carried out at least annually.
You can break the self-inspection into individual operational areas, you don’t need to audit the entire QMS in one go, in fact it is generally better to break the Self Inspection audits into individual areas to allow you to have a manageable CAPA plan in place for any deficiencies found.
In accordance to Chapter 8.2 of the EU GDP Guidelines (2013/C 343/01), you should have an audit schedule in place outlining when self-inspections will be carried out, and by whom.
The Responsible Person (RP) does not have to carry out self-inspections themselves.
They are permitted to delegate the task to a sufficiently trained member of staff chosen because they will be thorough and impartial (e.g. an RP’s Deputy). If you are breaking down the self-inspections into different areas, choose personnel who are ‘experts’ in each area to help carry out the self-inspection.
Although they can delegate the duty, the responsibility for the self-inspection remains with the RP, so they must check that it has been effective. If they are not the person performing the self-inspection they should be at the very least overseeing it, and decide which personnel will be carrying it out.
Use the EU GDP Guidelines (2013/C 343/01) as a tool for reviewing the compliance of your operations, procedures and documentation. MHRA inspectors will use them to ‘mark’ you against it, so you must ensure that you are compliant with them. Use the guidelines and the index for your SOPs to create a self-inspection checklist, allowing you to tick off when each of the areas has been covered.
All personnel will need to have had initial and continuous training on the company’s QMS and the EU Guidelines, with training records (including certificates) for each member of staff.
Training plans will also need to be reviewed during self-inspection to ensure the personnel have had regular training, and should be updated with any dedicated training that will be needed on any areas where deficiencies were found.
External Audits (also referred to as 2nd Party Audits)
External audits are performed by your organisation on your medicinal product suppliers and outsourced activity providers prior to them supplying products or performing services on your behalf.
You must perform thorough bona fide checks on any company that you work with to ensure they have experience with GDP compliance, understand what is required, and have a good reputation within the industry. These audits are to ensure that they are also fully compliant with GDP guidelines and HMR 2012 regulations.
Should a supplier or outsourced activity provider be non-compliant, this can result in an MHRA deficiency being noted as part of your own regulatory inspection. Quality Technical Agreements between yourself and your supplier/outsourced activity providers should allow for audits.
External audits should not just be performed in advance of beginning to work with them; they should be repeated on a risk-based basis to ensure that they are remaining compliant. You may also want to perform an audit in the event of a deviation, complaint or serious issue. This is commonly referred to as a ‘for cause’ audit.
Should any deficiencies or non-compliances be found during external audits, a remediation CAPA plan should be implemented by the supplier/outsourced activity provider, and they should confirm with you when the non-compliances have been resolved and deemed successful.
Consultant Audits and Regulatory Inspections (also referred to as 3rd Party Audits)
Having a third-party (a company that is not involved with your operations) carry out an audit of your site, is a very useful compliance tool (and a service that we offer).
In advance of a regulatory inspection, having a third-party audit does not mean you no longer have to carry out a self-inspection but can show you how to carry out an effective audit (especially helpful if you are just starting out), and help you prepare for MHRA inspections by identifying problem areas, and advising on what actions to take.
Regulatory inspections are performed by the MHRA upon application of a WDA (H) and again on at intervals in accordance with a risk-based approach.
Low risk operations are commonly inspected on a 4-year cycle however the higher the risk, the more frequent an inspector will perform an inspection on your operations. Should an inspector find critical or multiple major deficiencies during an inspection, your risk rating will change, and you may be inspected within the next 6 months or more frequently than 4 years.
It is important to note that MHRA inspections do not cover the entire QMS of an organisation, they are usually only on site for 1 to 3 days, depending on the size of your operation.
During the inspection they will audit a sample of your operations, they may only focus on warehouse operations or documentation such as SOPs or Technical Agreements. However, it is important to ensure that ALL of your GDP operations and procedures are compliant as they will not announce in advance of their visit as to which areas they will be sampling. Future inspections are likely to involve areas not audited on the previous visit, but the inspector may spend some time on previously inspected areas to ensure any non-conformances have been addressed.
Advice and Support
Do you need support on how to carry out a self-inspection or need a third-party audit?
Contact us using the form below with your requirements and we can arrange a consultation to discuss how our services can help you.
If you require GDP training or refresher training (which is an MHRA requirement expected at least annually), visit our online GDP training site where we have a range of courses available. You can also create accounts for you and your staff for free. Book places at our popular monthly all-day Webinar on GDP for RPs and Management.
All of our courses include pre-and post-course assessments to show your competency levels and understanding of the course content and we also supply certificates of completion for those that achieve the post-assessment pass rates.
Remember: Valid certificates are required as evidence of training at inspections!
Click the “visit training site” button to view our courses.
Below are links to other blog posts associated to this topic that may be of interest…
Self Inspections and First Party Audits
Top Tips for Audit Planning