CHemical
Aspects
Of
ToxICology
64th CHAOTIC MEETING MINUTES
29th April 2015
The Moat House, Acton Trussell, hosted by Instem
Morning Session:
Welcome and New Member Introductions
The meeting opened at 9.00am with Ian welcoming everyone to the 64th CHAOTIC
meeting and thanking Instem for hosting.
New members attended from the following companies:
AZ, CRL, HLS, Instem
Everyone was requested to check and complete the distribution list and to sign the
attendance form in order for CPD certificates to be distributed.
2 companies confirmed they had feedback of recent inspections.
All members were also asked to supply any questions for the help session.
Presentation: Computer System Validation, (CSV) – What is it – Adam
Woodjetts, Instem.
Feedback from recent MHRA Inspections
Company A 64th
meeting.docx
Company B 64th
meeting.docx
Discussion points:
Ian to raise expired Test items questions at next MHRC Consultative Committee
meeting ie what are their expectations.
A third company has been notified they will be inspected in June (was due March)
Ian also mentioned the case of fraud which had been investigated by the MHRA.
Person in question was given 6 month prison sentence. Ian to obtain summary slides
from MHRA.
Presentation: CSV – how vendors could help -Adam Woodjetts, Instem
CHemical
Aspects
Of
ToxICology
Presentation: Dispense – unlocking the Box – Dean Hatt (GSK)
Help Session
1. Do all companies have an SOP for procedure to deal with out of specification analytical
results?
Everyone does
Who drives the investigation? – mainly analyst and SD. Most companies state the
communication process in their SOP.
If SD can’t be located, then repeat analysis is initiated without their authorisation.
2. What characterisation documentation do companies require for biological?
Requirement same as for small molecule ie purity, expiry/retest date etc
Often stability running concurrently with study.
SD’s require sufficient information to judge that TA is suitable for use of their study.
3. If unlabelled vials are received, what is the process for dealing with these?
CROs raise with Sponsor, SD notified.
Vials returned to Sponsor for labelling or new labelled batch sent
Sending labels for CRO to put on the vials is unacceptable.
Labelling on outer package (eg box of vials) is not sufficient either.
4. For information, GSK recently received filters without an expiry date stated. When
followed up with the supplier, they said they are no longer putting expiry dates on
consumables such as filters. Be aware of this and check your consumables.
5. Has anyone experience with OpenLAB which is what Agilent are moving to?
No one at the meeting had but Teresa to follow up with a different site as they were
using it. Covance are moving from Empower to a new system, Chris to follow up.
6. Covance have received a new Silverson which is much larger than expected which
doesn’t fit in the LAFCs. Only 2 sizes now manufactured and nothing for small scale
manufacture. AZ have been looking for small scale mixers and Tabassum will send the
link to Bev. GSK have recently identified a small scale UltraTurrax in the Fisher
catalogue.
Presentation : ' Assessment of Vehicles for use in Oral Rodent Pre-Clinical Studies
– Tabassum Suleman (AZ)
Presentation : Harmonising Formulation Analysis procedures – Fiona McGuinness
(HLS)
CHemical
Aspects
Of
ToxICology
Presentation : The Quantos capsule machine working with Pristima – Chris Wood,
Covance
Website update – Dean Hatt
Website has been moved to a new platform. Presentations and minutes from previous
meetings will be held on there and members will be able to subscribe to e mail updates. It
can also be used for questions for the members in between meetings. Dean will send out e
mails soon detailing passwords and use.
AOB, Next Meeting, Subscriptions etc
Ian asked everyone to collect their invoices and pay their subscriptions.
Hosts for next meetings: AZ for Autumn and CRL for Spring 2016, both tbc.
As usual volunteers for presentations required.
Meeting ended at 3.15pm.