FOR WUXI APPTEC USE ONLY

 

 

PAYMENT METHOD

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

COMPANY NAME • STREET ADDRESS • CITY / STATE / ZIP

CONTACT NAME

PHONE

EMAIL

 

REQUESTED TESTING

   Is this part of a MDR remediation?    Yes    No

QTY TO BE TESTED

TEST CODE

TEST NAME

 

TEST ARTICLE INFORMATION

TOTAL NUMBER OF TEST ARTICLES IN SHIPMENT:

Test   Supply   Reference Standard  

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

CODE, BATCH, OR LOT NUMBER:

 

 

EXPIRATION DATE:

 

CONTROLLED STORAGE CONDITIONS

 

SAFETY PRECAUTIONS

 

STERILITY
Is article submitted sterile? Yes No

 

TEST ARTICLE PREPARATION & HANDLING

(Provide information if applicable. Attach additional pages if necessary.)

Preparation Instructions and Additional Comments               N.A.

Can the test
article be cut?

 

 

SURFACE AREA

MEASUREMENT

Per test article or group of component(s) for each extract:

 

cm2    N.A.

NOTE: Entire article will be tested unless information is provided here as to materials/components to be included/excluded for testing.

 

TEST ARTICLE DISPOSITION

(NOTE: Additional fee may apply for returns.)

Courier and account # for shipping:

(Required 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.

 

Check here if comparison/control article is being submitted. [If checked, you will see an additional section that must be completed.]

FORM-01355

ID 12345 ABCDE 6789

• Page 1 of 2

Revision:05

For GLP studies (required by US FDA)

 

TEST/CONTROL/COMPARISON 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.

No Sponsor-supplied control/comparison article is being submitted for testing.

Sponsor affirms Sponsor-supplied control/comparison article has been characterized or that characterization testing is planned. Sponsor confirms responsibility to retain proof of characterization.

Sponsor affirms Sponsor-supplied control/comparison article has been characterized and characterization information is included.

 

Sponsor is solely responsible for all test article and Sponsor supplied control/comparison article (if applicable) 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 and Sponsor supplied control/comparison articles shall be documented by the Sponsor. In those cases where marketed products are used as control articles, such products will be characterized by their labeling. Sponsor is also responsible for ensuring that test article and Sponsor supplied comparison/control article (if applicable) 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-01355

ID 12345 ABCDE 6789

• Page 1 of 1

Revision:05

COMPARISON / CONTROL ARTICLE INFORMATION

TOTAL NUMBER OF CONTROL ARTICLES IN SHIPMENT:

COMPARISON / CONTROL ARTICLE NAME (Exact wording will be used on reports.)

CODE, BATCH, OR LOT NUMBER:

 

 

EXPIRATION DATE:

 

CONTROLLED STORAGE CONDITIONS

 

SAFETY PRECAUTIONS

 

STERILITY
Is article submitted sterile? Yes No

 

CONTROL ARTICLE PREPARATION & HANDLING

(Provide information if applicable. Attach additional pages if necessary.)

Preparation Instructions and Additional Comments               N.A.

Can the test
article be cut?

 

 

SURFACE AREA

MEASUREMENT

Per test article or group of component(s) for each extract:

 

cm2    N.A.

NOTE: Entire article will be tested unless information is provided here as to materials/components to be included/excluded for testing.

 

COMPARISON / CONTROL
ARTICLE DISPOSITION

(NOTE: Additional fee may apply for returns.)

Courier and account # for shipping:

(Required 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.

 

For GLP studies (required by US FDA)

 

TEST/CONTROL/COMPARISON ARTICLE CHARACTERIZATION

 

Sponsor affirms test article has been characterized or that characterization testing is planned.

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

No Sponsor-supplied control/comparison article is being submitted for testing.

Sponsor affirms Sponsor-supplied control/comparison article has been characterized or that characterization testing is planned. Sponsor confirms responsibility to retain proof of characterization.

Sponsor affirms Sponsor-supplied control/comparison article has been characterized and characterization information is included.

 

Sponsor is solely responsible for all test article and Sponsor supplied control/comparison article (if applicable) 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 and Sponsor supplied control/comparison articles shall be documented by the Sponsor. In those cases where marketed products are used as control articles, such products will be characterized by their labeling. Sponsor is also responsible for ensuring that test article and Sponsor supplied comparison/control article (if applicable) 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-01355

ID 12345 ABCDE 6789

• Page X of Y

Revision:05