Investigational medicinal products Flashcards
For the following IMP Supply chain, can you explain the requirements:
IMP (DP) QP Certified in Germany - Imported and Stored at GB hub - sent to NHS study site
In other words describe the requirements for IMP Oversight.
What would be the additional requirements or differences if the IMP was imported directly from Germany to NHS study site?
What are the high level changes in the Clinical Trial Regulation?
Wha t is a Imp Protocol, why it is needed, what are the content in it and where will you find it.
What is IMPD and PSF, what is the difference in both and why do you need it.
When you have the PSF why do you need IMPD for certification and vice-versa.
What is the investigation Brochure and whats the content in it. Why is this needed
The requirement of IMP labels, how it is different wrt commercial products. What are the contents, where will you find the details wrt UK and EU.
What system of wordings would you use to prevent unblinding?
Your company informs you that they want to transfer their R&D unit next to your manufacturing site. What do you need in place?
What are the differences between commercial and IMPs?
Is GMP for API required for IMPs?
IMP sent to Canada clinical trial site, wrong IMP sent to UK IMP instead, what do you do?
You work in a facility and they are packing aspirin, however they want to do a clinical trial and they want to pack in the same line IMP and placebo, what do you need? What are the risks ?
A sterile IMP product having a light yellow colour solution compared to previous batch.
*Aseptic technique/terminal sterilisation
* Depyrogenation technique
* PSF
* Single blinded/double blinded
What are the challenges for manufacturing of IMP products?
You’re packaging a blinded, randomised IMP, what extra considerations are there?
o What is needed on the packaging line to ensure no mix ups?
o What should you put on the packaging to ensure there is no cross contamination?
Its placebo controlled. How would you ensure blinding?
What is needed on the packaging line to ensure no mix ups
What should you put on the packaging to ensure there is no cross contamination?
What is double blinded study? What controls you would expect to see in primary packing of such type of trial? How would you ensure that blind is maintained throughout the trial? What documentation you would require?
Scinario: You’re are a QP at an IMP site. You have noticed that your example pack in your Batch Packaging Record has a carton with label with information missing. Would you release the batch? (about 15 mins)
Follow up: ap. The information “for clinical trial use only” missing
Follow up: aq. You have found this information missing on the pack in BPR itself.
Follow up: ar. Yes, it is a blinded study. Why are you bothered if this statement is missing in some packs?
Follow up: as. OK so your packaging operator said all other packs are good, no issues
Follow up: at. OK so you went down to the shop floor, laid out all the 200 packs and seen that none of the labels are missing any information. Are you going to release the batch now?
Follow up: au. Ok your reference sample are all ok, retention sample is ok too, just this one dummy carton on the BPR is missing this information.
Follow up: av. What do you think might have caused this?
Follow up: aw. What are your proposed CAPA?
Follow up: ax. Do you think your labelling issue will be resolved using the software update you propose as CAPA? What other considerations you would like to put in?
ay. What will you put in place as an interim control? How will you ensure 100 % checks are carried out?
Risk-Based IMP Classification: 4 types
- Non-authorised IMP (highest risk) — New chemical entities.
- Authorised IMP but new indication (not in SmPC).
- Authorised IMP but new conditions of use (new route/population).
- Authorised IMP used within SmPC (lowest risk).
How manage Shelf-life extension required during a clinical trial?
• Check CTA if shelf-life extension is pre-approved.
• If not, raise a substantial amendment for MHRA and REC approval.
• Execute change control.
• Prepare approved labels (Annex 13 guidance).
• Ensure QP oversight:
• Approve procedure/protocol.
• Check segregated relabelling area.
• Ensure reconciliation and no unblinding risk.
• Relabelling should not obscure original information (Annex 13).
• Re-release is not always required but QP oversight is essential.
• if it is conducted in MIA/IMP site, recall and IMP/QP certification required.
