Viral Clearance Sample Submission Form
Eurofins Document Reference:
1-P-QM-FOR-9009045 / Revision: 5 / Historical Reference: Form 6869
Effective date: Jul 4, 2017 / Status: Effective
Submitting Company/Client Acct. No. / Intermediate Product (Biologic)
Other (Explain)
REQUIRED TO CHOOSE ONE / GMP Commercial (Lots Intended or On Market) GMP Non-Commercial Non-GMP
REQUIRED TO CHOOSE ONE
On Behalf Of:
Reporting Contact(s):
Quote #
PO #
Eurofins Contact:
Dispose of Sample- Yes Hazardous- BSL2- Blood Pathogen-
No Provide FedEx/UPS______Controlled Substance, Class-______
Name of process step(as listed in the quote or the protocol) / Virus
(P all that apply) / P for interference testing / sample storage conditions
(P Required cond.) / Sample Description
(As you would like Referenced on the CoA)
XMuLV / MVM (MMV) / Pseudorabies Virus / Reovirus / Porcine Parvovirus / Room Temp / Refrigerated / Frozen (-20C) / Frozen (-70C)
Comments:
Signature/Date: ______
Guidance Document for Viral Clearance Request Form
To avoid delays in testing, the following information is required to be indicated on the form, if any of the following information is missing testing will not be initiated until all information can be supplied:
· PO and/or Quote number. If you do not have either, please enter NA.
· If large quantities of samples will be submitted, a secondary page with sample and testing information must be attached to the original form.
· Laboratory location that will be completing testing.
· Signature and date (Can be hand written or electronically signed). Indicates approval with all applicable terms and conditions needed to initiate testing. One sample submission form is to be used per quote and material.
· Please provide separate containers for Interference and Spiking Steps and identify which steps they go to.
· An MSDS must be provided for all materials, if one is not on file samples will be placed on hold.
· Email a copy of the completed form to your ELLI contact prior to submission and send a hard copy with the samples.
· If you are a new client contact, you must provide an address, phone number, and email address.
Disclaimers:
· If the storage condition is not identified, a condition similar to how the sample was received will be assigned.
· Sample discard, if no contact information is provided the samples will be discarded appropriately at no charge after the Certificate of Analysis is generated. (15 days for water testing and 30 days for all other testing.) Note: If sample return is requested a FedEX or UPS account number must be supplied.
· List the sample description and storage conditions as you would like it to appear on the final report. Sample descriptions should match what is written on the container.
· If the measurement of uncertainty is required as per the ISO 17025 standard, then indicate in the comments section.
Address for shipment:
Lancaster, PA (USA): 2430 New Holland Pike, Suite C100, Lancaster, PA 17605
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