FOR WUXI APPTEC USE ONLY

 

PAYMENT METHOD (required):

REQUIRED: All applicable information must be completed on this
form and a print copy must be included in your test article shipment.

SHIP TO: WuXi AppTec • 2540 Executive Drive • St. Paul, MN 55120

(1) 651.675.2000 TOLL FREE 888.794.0077

 

This form is incomplete / missing required information

and is not ready for submission to WuXi AppTec.

 

This form may be incomplete / missing required information

and is not ready for submission to WuXi AppTec.

Please use the Print/Save button at the bottom of the form.

Used for extra space

 

QUOTE NUMBER (QUO - ##### - ###### - #)

 

QUO - - -

 

CLIENT INFORMATION

 

Account Number (required):

COMPANY NAME • STREET ADDRESS • CITY / STATE / ZIP

CONTACT NAME

PHONE

EMAIL

 

TESTING TO BE CONDUCTED:

GLP     Non-GLP     GMP

 

REQUESTED TESTING

CLICK HERE to view a PDF with listings of available OI tests.

TEST CODE

TEST NAME

 

Enter the test code, hit “Tab” and the test name will automatically populate from our database.
Also, additional form sections will now appear depending on your requested test.

NOTE:
If you are ordering a custom or client-specific assay, you MUST
provide your Quote Number and Account Number above.

 

 

TEST ARTICLE INFORMATION

TOTAL NUMBER OF TEST ARTICLES IN SHIPMENT:

TEST ARTICLE NAME (Exact wording will be used on reports.)

CONTROLLED STORAGE CONDITIONS

 

LOT / DONOR ID NUMBER

EXPIRATION DATE

QUANTITY

 

For WuXi AppTec Use Only

PROJECT NUMBER

 

 

 

 

 

 

 

 

 

 

 

Check here if more space is needed to list Lot / Donor ID numbers. An additional page – with space for continued listings – will be added.

 

FORM-01364

ID 12345 ABCDE 6789

• Page X of Y

Revision:03

 

COMMENTS / SPECIAL HANDLING

 

 

TEST ARTICLE DISPOSITION

 

Courier and account # for shipping:

(Required for returns)

(NOTE: Additional fee may apply for returns.)

For GLP Testing: Part 58 of the Code of Federal Regulations (CFR), which describes the requirements for Good Laboratory Practice (GLP) for Non Clinical Laboratory Studies, states in section 58.105, part (d), that “For studies of more than 4 weeks duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by 58.195.” Please provide one additional sample per batch of test and control article for WuXi AppTec to retain. If you are unable to supply the additional sample, it will be noted in the Final Report.

 

Services requested in this form will be governed in accordance with WuXi AppTec's “Standard Terms and Conditions.” To the extent WuXi AppTec's Standard Terms and Conditions are in conflict with an applicable agreement (Agreement) between Customer listed in this form and WuXi AppTec, such Agreement will govern.

 

 

 

To save an electronic copy
of this completed form, select
Adobe PDF Writer or
Microsoft XPS Document Writer

in your print dialog.

 

Always print a hard copy
to ship with your samples.

TESTING APPROVED BY:

Sponsor signature is required before testing will be initiated.

 

 

 

 

 

 

SIGNATURE

 

PRINT NAME

 

DATE

 

 

FORM-01364

ID 12345 ABCDE 6789

• Page X of Y

Revision:03

 

 

TEST ARTICLE INFORMATION

TOTAL NUMBER OF TEST ARTICLES IN SHIPMENT:

TEST ARTICLE NAME (Exact wording will be used on reports.)

LOT NUMBER / DONOR NUMBER

EXPIRATION DATE:

PRODUCT STATE

CONTROLLED STORAGE CONDITIONS

 

STERILITY Is article submitted sterile? Yes No

 

OPTIONS FOR TESTING

 

IMPLANT LOCATION – SELECT ONE

Intramuscular (in muscle pouch): Biceps femoris Intermuscular (between muscle pouch): Adductor brevis and semimembranous
Intramuscular (in muscle pouch): Gluteal Intermuscular (between muscle pouch): Biceps femoris

AMOUNT OF SAMPLE TO BE IMPLANTED: per site (i.e., weight, vol)

 

TEST ARTICLE DISPOSITION

 

Courier and account # for shipping:

(Required for returns)

(NOTE: Additional fee may apply for returns.)

For GLP Testing: Part 58 of the Code of Federal Regulations (CFR), which describes the requirements for Good Laboratory Practice (GLP) for Non Clinical Laboratory Studies, states in section 58.105, part (d), that “For studies of more than 4 weeks duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by 58.195.” Please provide one additional sample per batch of test and control article for WuXi AppTec to retain. If you are unable to supply the additional sample, it will be noted in the Final Report.

 

FORM-01364

ID 12345 ABCDE 6789

• Page 1 of 2

Revision:03

 

COMMENTS

 

 

For GLP studies (required by US FDA)

TEST ARTICLE CHARACTERIZATION

Sponsor affirms test article has been characterized or that characterization testing is planned. Sponsor confirms responsibility to retain proof of characterization.

Sponsor affirms test article has been characterized and characterization information is included.

Sponsor is solely responsible for all test article characterization data as required in Good Laboratory Practices (GLP) regulations (21CFR58) Section 58.105 – identity, strength, stability, purity, and chemical composition. Methods of synthesis, fabrication, or derivation of the test articles shall be documented by the Sponsor. Sponsor is also responsible for ensuring that test article here submitted is representative of the final product that will be subjected to materials characterization.

 

Services requested in this form will be governed in accordance with WuXi AppTec's “Standard Terms and Conditions.” To the extent WuXi AppTec's Standard Terms and Conditions are in conflict with an applicable agreement (Agreement) between Customer listed in this form and WuXi AppTec, such Agreement will govern.

 

 

 

To save an electronic copy
of this completed form, select
Adobe PDF Writer or
Microsoft XPS Document Writer

in your print dialog.

 

Always print a hard copy
to ship with your samples.

TESTING APPROVED BY:

Sponsor signature is required before testing will be initiated.

 

 

 

 

 

 

SIGNATURE

 

PRINT NAME

 

DATE

 

 

FORM-01364

ID 12345 ABCDE 6789

• Page 2 of 2

Revision:03

 

TEST ARTICLE INFORMATION

LOT / DONOR ID NUMBERS – CONTINUED

 

LOT / DONOR ID NUMBER

EXPIRATION DATE

QUANTITY

 

For WuXi AppTec Use Only

PROJECT NUMBER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FORM-01364

ID 12345 ABCDE 6789

• Page X of Y

Revision:03

 

COMMENTS / SPECIAL HANDLING

 

 

TEST ARTICLE DISPOSITION

 

Courier and account # for shipping:

(Required for returns)

(NOTE: Additional fee may apply for returns.)

For GLP Testing: Part 58 of the Code of Federal Regulations (CFR), which describes the requirements for Good Laboratory Practice (GLP) for Non Clinical Laboratory Studies, states in section 58.105, part (d), that “For studies of more than 4 weeks duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by 58.195.” Please provide one additional sample per batch of test and control article for WuXi AppTec to retain. If you are unable to supply the additional sample, it will be noted in the Final Report.

 

Services requested in this form will be governed in accordance with WuXi AppTec's “Standard Terms and Conditions.” To the extent WuXi AppTec's Standard Terms and Conditions are in conflict with an applicable agreement (Agreement) between Customer listed in this form and WuXi AppTec, such Agreement will govern.

 

 

 

To save an electronic copy of this completed form, select
Adobe PDF Writer or
Microsoft XPS Document Writer

in your print dialog.

 

Always print a hard copy
to ship with your samples.

TESTING APPROVED BY:

Sponsor signature is required before testing will be initiated.

 

 

 

 

 

 

SIGNATURE

 

PRINT NAME

 

DATE

 

 

FORM-01364

ID 12345 ABCDE 6789

• Page X of Y

Revision:03