MHRA Inspection: Are You Ready?

Being ready for the MHRA inspector

• Does your organisation go into panic mode the second you receive notification from the MHRA that they are coming to perform an inspection on your quality systems? 

• Do your quality team frantically start pulling 5 years’ worth of documents from your archive area? 

• Are you staff subjected to last minute and rushed GDP training in the run up to the MHRA inspection? 

• Does your maintenance team call every painter and decorator in a 10-mile radius to try and get your facilities re-painted days before the Inspector arrives? 

There is a straightforward way to avoid all this commotion, which 9 times out of 10 just disrupts your business commercial and quality activities and does nothing to prepare your quality team and wider staff for the MHRA inspection…. and that is by always being inspection/audit ready! 

Whilst most companies are given two-four weeks’ notice of an MHRA inspection, the inspectorate can and do turn up at any time. 
Therefore, it is essential that you remain as up to date as you can be at any given point in time. 

For those of us who are perhaps less ready, what should you be doing in preparation for your MHRA GDP inspection? 

Inspectors will be looking for compliance with EU Guidance on Good Distribution Practice for medicines for human use, 2013/C 343/01 and the relevant sections of the Human Medicines Regulations 2012 (HMR) will  compare a sample of your operations against these sets of guidelines and regulations. 

We strongly recommend that you compare your current procedures and processes against these guidelines and regulations as part of a self-inspection to ensure you are compliant, at least at a minimum level and address any gaps or deficiencies by way of a deviation and CAPA plan.  

Remember – if you have not documented it, you have not done it! 

Questions to ask yourself before an MHRA Inspection 

 Quality Management System: 

1. Do you have a well-maintained Quality Management System (QMS) in place? 
2. Does your QMS encompass all of the relevant policies and procedures required by the guidelines and regulations and does it relate to your business model? Many start up organisations buy ‘off the shelf’ procedures which may not truly reflect the operations of your organisation. 
3. Does your WDA (H) include all product types and activities performed? Is the named Responsible Person still your RP? Do you have a Controlled Drug Licence if you handle such medicines? 
4. Do you have a deviation and CAPA system in place? Are deviations categorised by quality or service? Are deviations investigated and root cause established, and do you accept human error as a standalone root cause? 
5. Have you performed risk assessments on your QMS? 
6. Do you effectively manage and document change controls? 
7. Are Quality Management Reviews performed and shared with relevant personnel? 

Training: 

1. Does your RP have Cogent approved Gold Standard training? 
2. Does your RP understand the 12 documented responsibilities in accordance with EU GDP Guidelines and HMR 2012? 
3. Are all your staff fully trained in GDP prior to commencing their roles? 
4. Is all training documented and are your training records up to date? 
5. Is your organisation chart up-to-date and does it accurately show the roles and reporting lines of your staff? 
6. Do you have signed and dated job descriptions in place for your staff? 

Premises and Equipment:
 

1. Are your premises suitable for the medicinal products you store and handle? 
2. Do you have temperature monitoring in place? 
3. Is your temperature monitoring equipment calibrated to a national standard 
4. Do you have pest control in place? 
5. Do you keep cleaning records for your storage areas? 
6. Do you have contingency plans in place for maintaining the storage conditions of your products in the event of a power failure? 
7. Do you have a maintenance log for key equipment? 
8. Is your computer system validated? 

Documentation: 

1. Is your documentation readily available? 
2. Are your documents version controlled, paginated, signed by appropriately trained personnel 
3. Do you apply ALCOA+ principles to your documentation? 
4. Do you retain documentation for the relevant time-period? 
5. Do you have backup systems in place, do they work, do they protect documents from adulteration? 

Operations: 

1. Are your customers bone fide, is this documented, are customer bone fides reviewed on a regular basis? 
2. Do you qualify your suppliers? Do you perform checks on their WDA and GDP Certificates? Do you have an approved supplier list? Are written agreements in place with your suppliers and are they regularly reviewed? 
3. Are your sales and purchasing records readily available 
4. Do you have written procedures in place for all operational activities 
5. Are your Standard Operating Procedures written to ALCOA principles, document controlled and approved by the RP prior to rolling out to your staff? Are your staff trained in the SOPs, if so, is this documented? 

Complaints, Returns, Recalls, Falsified Medicines:

 

1. Do you have documented procedures for complaints, returns, recalls? 
2. Are your complaints categorised by type? 
3. Are complaints fully investigated and CAPAs implemented when required? 
4. Are your returned products only returned to saleable stock if approved by your RP? 
5. Do you perform mock recall exercises in the event of no live recalls? Is this exercise documented? 
6. Do you have procedures in place to detect falsified medicines, are purchasing and distributing staff trained in this procedure? 

Outsourced activities: 

1. Do you have written agreements in place with your outsourced activity providers? 
2. Does your written agreement clearly stipulate the responsibilities of all parties? 
3. Do you perform audits on your outsourced activity providers? 

Self-Inspections: 

1. Do you have a self-inspection programme in place? Is it followed? 
2. Are personnel involved in performing self-inspections trained? 
3. Are self-inspection audits documented? Are the reports shared with relevant personnel? 
4. Are deficiencies identified during self-inspections subject to CAPAs and follow up? 

Transport: 

1. Have you validated your transport provider? 
2. Are you confident that they can maintain the storage requirements of your medicinal products? 
3. Have you risk assessed your delivery routes? 
4. Do you ensure that deliveries are only made to the address stated on the delivery label or do you allow ‘delivery to a safe place’? 
5. Is the packaging you use to transport medicines validated? 

Brokers: 

1. Are you a broker of medicinal products? Are you familiar with the regulatory requirements for brokers? 

The above questions are in no way exhaustive; we urge you to review the EU GDP Guidelines and HMR 2012 and perform a full gap and risk assessment of your QMS and operations against these standards on a regular basis.   

Worried about the current status of your QMS? Is your next MHRA inspection due in the coming months? Do you need help reviewing your operations for compliance? Would you like support preparing for your next inspection? 

 Our team of experience quality specialists can help. Contact us for more information and a free consultation. 

Welcome to a new paradigm!