MHRA Inspection – Questions for Pharmacy staff
The majority of questions were collated from real MHRA inspections across various NHS Trusts and Universities.
Please be aware that this is by no means a complete set of questions and the MHRA will ask additional or differently phrased questions.
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Staff should bring their updated training record to the preparation interview.
About you
- What is your pharmacy background?
- Tell me about your experience on clinical trials (% non-commercial, % commercial)
- How many active CTIMPs and other studies at the moment?
- What type of GCP training have you had? (provider, what topics were covered, UK Clinical Trial Regulations included?) Why is there no record of GCP training on your CV?
- Have you done any other training for this role?
- Are you aware of recent changes to the UK legislation around CTIMPs?
About pharmacy
- Explain the pharmacy trial approval process
- Do you follow this process for trust-sponsored trials only?
- What do you do for old studies? Do you go back and fix?
- Have you performed any audits of old studies?
- Have you gone through current studies and identified gaps?
[Inspector commented that pharmacy should always ask: are patients safe, are you assured of the quality of the product. Pharmacy is the ‘gatekeeper’. Shouldn’t approve anything that pharmacy is not happy with]
- Is there any guidance for researchers on what goes into trial protocols for pharmacy?
- What if you left, is the information available?
- Can you clarify what happens if a drug is donated? Where would the drug come? Is there any procedure?
- What process do you have for drug accountability?
- How are you given notification that the drug is on its way?
- Do you order the drug?
- Where was the drug stored?
- What do you check for in the paperwork?
- What do you check regarding the quality of the drug?
- Do you request CoA?
- How long does the drug stay in pharmacy?
- Was the drug labelled when it arrived and were there any amendments to the label made?
- Have you any process in place for NIMPs?
- Do you supply IMP to other sites?
- Are there any recall procedures? Do you check recall procedures? Is it checked for other sites?
- Are you hosting paediatric trials?
- Do you get materials from GMP-compliant organisations?
- Do you have any trial data stored in electronic formats? [if you do introduce this, ensure that any computer system is validated and test before transferring any electronic data]
- How do you ensure that you have the latest version of the protocol?
- Do you keep temperature records?
- Is the fridge alarmed?
- How do you know if the temperature goes out of range if out of hours?
- Do you have a process to check where each IMP is located?
- Do you track movement of drug if storage location is changed?
- Inspector asked for minutes from a review meeting for a commercial study.
- Do you train those dispensing trial drugs, what evidence is there of this?
- Who does the dose calculations?
- Are instructions for use given to patients?
- Where are the labels kept?
- Are the labels checked before given out?
- Is that check documented?
- Who produces the label templates and how are they stored?
- Who is the drug dispensed to?
- Who and how is the script signature checked?
- Is there a NHSG policy on signing scripts?
- Technician was asked about dispensing method version controlled, code break envelopes, shipping receipts.
MHRA Inspection – Interview questions for CI, PI, Sub-Investigator V1,06 May 2011 p. 1of 2