GLP SAMPLE SUBMISSION FORM –
W ith Control Article
www.namsa.com
Instructions
This form must be completed electronically using Microsoft Word. Upon completion, please return this form with the signed Cost Estimate
Proposal. Upon receipt of these two documents, NAMSA will e-mail custom protocols to you. If you have any questions, please contact a
NAMSA Client Care Specialist domestically at 1-419-662-4850 ohclientcare@namsa.com or internationally at 1-419-666-9455. Thank you for
your business.
Ship To Information (final report will be mailed to this address)
Company Name:
Contact:
Address:
City, State, Zip:
Country:
Phone:
Fax:
E-mail:
Purchase Order:
Credit Card:
Prepayment:
Bill To Information Same as Ship To Information
Company Name:
Address:
City, State, Zip:
Country:
Phone (Accounts Payable):
Reports should also be sent by:
Fax
E-mail
Cost Estimate Proposal Number:
Method of Payment (please choose one)
Purchase Order Number:
Credit Card Bill To Name:
Phone Number for Bill To Name:
Prepayment Amount:
Prepayment Type: Please choose one if applicable
Test Article Information
Name**:
Identification**:
Test Article Can be Cut:
Surface area in cm2 or dimensions:
Please choose one
Yes
Enter Batch Code or Lot Number:
No (for tests where extraction is required, the test article is cut and thus destroyed)
(NOTE: If surface area is unknown, NAMSA will calculate.)
Extraction Conditions:
121°C/1 hour
(NAMSA recommends the highest temperature
that will not degrade the test article)
50°C/24 hours (hexane only)
Thickness:
(only applies to solids, if a liquid, powder, or gel,
place information in the Test Article Special
Instructions)
Weight:
70°C/24 hours
50°C/72 hours
37°C/24 hours (cytotoxicity only)
37°C/72 hours (requires justification)
Other (specify)
Justification for 37°C/72 hours:
< 0.5 mm
> 0.5 mm
For the Colony Assay Study only:
weight or
surface area
Irregularly shaped objects and/or sponsor option - ratio of 4 g:20 mL
(NOTE: Test article will be prepared by surface area. If surface area is not supplied by the
Sponsor or cannot be calculated by NAMSA, the sample will be prepared by weight.)
Quantity Submitted***:
Sterilization:
Storage Conditions**:
Sterile
Not Sterile
NAMSA to Sterilize (additional fee will apply)
Please choose one
Physical Description** (e.g. size, shape,
color, texture):
Intended Clinical Use:
Type:
Please choose one
If Other, please describe:
Special Instructions (preparation/handling):
*A detailed composition list and current MSDS must accompany any chemical, pharmaceutical, biologic, or medical device submitted as a liquid, powder,
paste, or gel. A certificate of testing or reprocessing must be submitted for any human-tissue-derived sample or clinically used medical device.
**This information will appear in your final report.
***For tests that are >28 days in life, NAMSA must retain a representative portion of the test article in archives. Be sure to send enough test article.
Test Article Characterization
REV053112
GLP SAMPLE SUBMISSION FORM –
W ith Control Article
www.namsa.com
The sponsor assures the above test article has been characterized for identity, strength, purity, and composition as required
by FDA Good Laboratory Practice Regulations of 21 CFR Part 58.105. Stability testing is the responsibility of the sponsor
and is subject to FDA audit. Test Article Characterization definitions are available for download in pdf format on our website.
Click this link http://www.namsa.com/clients/ to locate this pdf.
Test Article Stability
Test Article Mixture Analysis
Stability testing is in progress and sponsor affirms that
test article is stable for duration of intended testing.
Stability testing is complete and on file with sponsor.
Expiration Date Required:
Marketed product stability is characterized by its
labeling. Label with expiration date must appear on
the product. Expiration Date Required:
Analysis is not necessary because test article is a solid,
powder, gel, or liquid being extracted or being tested as
received (will not be mixed with a carrier).
Sponsor will provide analytical methods.
Sponsor will perform analysis on representative aliquots
provided by NAMSA. Results must be provided to NAMSA.
Test Article Strength
Test Article Purity
Test Article Composition
Strength is:
Strength is not applicable because
no active ingredients are used to
formulate a concentration.
Purity is:
Purity is not applicable because
the test article does not contain an
active ingredient.
Test article is composed of the following
materials:
Control Article Characterization
NAMSA will specify when a sponsor-submitted control article is necessary. NAMSA provides controls for most routine studies. If you
have questions, please contact a NAMSA Client Care Specialist at 419.662.4850 or ohclientcare@namsa.com.
Article Name:
Identification:
Please choose one
Enter Batch Code or Lot Number:
Quantity Submitted:
Sterilization:
Sterile
Not Sterile
NAMSA to Sterilize (additional fee will apply)
Physical Description (e.g. size, shape,
color, texture):
Intended Clinical Use:
Type:
Please choose one If Other, please describe:
Control Article Strength
Control Article Purity
Control Article Composition
Strength is:
Strength is not applicable because
no active ingredients are used to
formulate a concentration.
Purity is:
Purity is not applicable because the
test article does not contain an active
ingredient.
Control article is composed of the
following materials:
Control Article Stability
Control Article Mixture Analysis
Stability testing is in progress and sponsor affirms that
test article is stable for duration of intended testing.
Stability testing is complete and on file with sponsor.
Expiration Date Required:
Marketed product stability is characterized by its
labeling. Label with expiration date must appear on
the product. Expiration Date Required:
Analysis is not necessary because test article is a solid, powder,
gel, or liquid being extracted or being tested as
received (will not be mixed with a carrier).
Sponsor will provide analytical methods.
Sponsor will perform analysis on representative aliquots
provided by NAMSA. Results must be provided to NAMSA.
Test/Control Article Disposition
After testing, NAMSA should:
Discard used and unused test article
*Method of Return Shipment
REV053112
GLP SAMPLE SUBMISSION FORM –
W ith Control Article
www.namsa.com
Return unused test article (additional fees will be applied)*
Please choose one if applicable
Return used & unused test article (additional fees will be applied)*
Account #:
Other:
The quote provided to you details the test(s) to be conducted. If there are tests that you do not want NAMSA to
conduct, please line through them on the quote.
Please print this form and sign. Signature must be handwritten.
Sponsor Signature:
Date:
REV053112