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picture1_Bill Format In Word 11801 | Glp Sample Submission Form With Control Article | Sample Submission


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File: Bill Format In Word 11801 | Glp Sample Submission Form With Control Article | Sample Submission
estimate proposal if you have any questions please contact a namsa technical specialist  ...

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                                                  GLP SAMPLE SUBMISSION FORM – With Control Article
                                                                                                                                            www.namsa.com
          Instructions
          This form must be completed electronically using Microsoft Word. Upon completion, please print this form then sign and date it at the 
          bottom. Please include this form with your sample and ship to the NAMSA address that appears on your Cost Estimate Proposal. If you
          have any questions, please contact a NAMSA Technical Specialist at +33 (0)4 78 07 92 34. Thank you for your business.
          Ship To Information (final report will be mailed to this                       Bill To Information   Same as Ship To Information
          address)
          Company                                                                        Company Name:                           
          Name:
          Contact:                                                                       Address:                                
          Address:                                                                       City, State, Zip:                       
          City, State, Zip:                                                              Country:                                
          Country:                                                                       Phone (Accounts                         
                                                                                         Payable):
          Phone:                        
          Fax:                          
          E-mail:                                                                        Cost Estimate Proposal Number:      
                                                                      Method of Payment
              Purchase           Purchase Order Number:      
          Order:
                                                                   Test Article Information
          Test Article Name**:                                           
          Test Article reference**:                                      
          Test Article Identification**:                        Enter Batch Code or Lot Number:      
          Test Article Can be Cut:                                 Yes          No  (cutting can expose inner surfaces to the extraction vehicle)
          Test Article Surface area in cm2 **:                       
          Extraction Conditions:                                   121°C/1 hour          70°C/24 hours         50°C/72 hours         37°C/24 hours 
          (NAMSA recommends the highest                         (cytotoxicity only)
          temperature that will not degrade the test               37°C/72 hours        Other (specify)
          article)                                              In case no condition is selected by the Sponsor, NAMSA will automatically use 50°C/72
                                                                hours for extraction, unless 37°C is specifically required for the test.
          Thickness:                                               < 0.5 mm ratio of  6 cm2/mL             > 0.5 mm ratio of 3 cm2/ mL
          (only applies to solids. If a liquid, powder or gel,     Irregularly shaped objects and/or sponsor option-ratio of 0.2 g/ mL (only if the 
          place information in the Test Article Special         surface area cannot be defined – surface ratio should be preferred according to 
          Instructions)                                         ISO 10993-12)
          Dimensions/Weight:                                         
          Quantity Submitted***:                                         
                                                                   Sterile      Non Sterile    Sterilization process : Please choose one 
          Sterilization**:                                                                     If Other, please describe:                          
                                                                   NAMSA to sterilize (additional fee will apply)
          Storage Conditions**:                                 Please choose one
          Physical Description**:                                        
          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, cosmetic, biologic or medical device presented as a liquid, 
          powder, paste, 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.
          *** Pharmaceutical and cosmetic: at least one additional sample must be supplied and retained at NAMSA as sampling product for all the studies.
          Page 1/4                                                                                                                E-QUA 238v2 – 29/08/2011
                                                  GLP SAMPLE SUBMISSION FORM – With Control Article
                                                                                                                                             www.namsa.com
                                               Reminder (will automatically be fulfilled before printing)
          Test Article Name:                                     Error: Reference source not found
          Test Article reference:                                Error: Reference source not found
          Test Article Identification:                           Enter Batch Code or Lot Number: Error: Reference source not found
                                                                Test Article Characterization
          The sponsor assures the above test article has been characterized for identity, strength, purity, homogeneity and composition as 
          required by Good Laboratory Practice Regulations. Stability testing is the responsibility of the sponsor and is subject to authorities’ 
          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 before opening 
          packaging                                                               Test Article Stability after opening packaging
              Stability testing is in progress and sponsor affirms that               Stability after opening packaging is:       Please choose one
              test article is stable for duration of intended testing.
              Stability testing is complete and on file with sponsor.
              Expiration Date (DD/MM/YYYY):   /  /    
              Marketed product stability is characterized by its                      Stability after opening packaging is not applicable.
              labeling.
              Expiration Date (DD/MM/YYYY):   /  /    
          Test Article Mixture Analysis                                           Test Article Homogeneity
              Analysis is not necessary because test article is a solid, 
              powder, gel, or liquid being extracted or being tested as               Test article is a homogeneous gel, liquid or powder.
              received (will not be mixed with a carrier).
                                                                                      Test article is a non-homogeneous gel liquid or powder.
                                                                                      Instruction before use to assure homogeneity :      
              Sponsor will perform analysis on representative                         Homogeneity is not applicable because no sampling is performed 
              aliquots provided by NAMSA. Results must be provided                    before testing or the test article is a solid.
              to NAMSA.
          Test Article Strength                              Test Article Purity                         Test Article Composition
              Strength is:                                       Purity is:          
              Strength is not applicable because no              Purity is not applicable because        Test article is composed of the following 
              active ingredients are used to                     the test article is a multi-            materials/ingredients:          
              formulate a concentration.                         component device.
                                                                    Test Article Disposition
          After testing, NAMSA should:
              Discard used & unused test article                                      *Method of Return Shipment
              Return unused test article (additional fees will be                     Please choose one if applicable        Other:          
          applied)*
              Return used & unused test article (additional fees will be              Account #:      
          applied)*
          Page 2/4                                                                                                                  E-QUA 238v2 – 29/08/2011
                                                    GLP SAMPLE SUBMISSION FORM – With Control Article
                                                                                                                                                  www.namsa.com
                                                                     Control Article Information
           Control Article Name**:                                          
           Control Article reference**:                                     
           Control Article Identification**:                       Enter Batch Code or Lot Number:      
           Control Article Can be Cut:                                Yes           No  (cutting can expose inner surfaces to the extraction vehicle)
                                                 2 
           Control Article Surface area in cm **:                       
           Extraction Conditions:                                     121°C/1 hour           70°C/24 hours          50°C/72 hours          37°C/24 hours 
           (NAMSA recommends the highest                           (cytotoxicity only)
           temperature that will not degrade the test                 37°C/72 hours          Other (specify)
           article)                                                In case no condition is selected by the Sponsor, NAMSA will automatically use 50°C/72
                                                                   hours for extraction, unless 37°C is specifically required for the test.
           Thickness:                                                 < 0.5 mm ratio of  6 cm2/mL               > 0.5 mm ratio of 3 cm2/ mL
           (only applies to solids. If a liquid, powder or gel,       Irregularly shaped objects and/or sponsor option-ratio of 0.2 g/ mL (only if the 
           place information in the Test Article Special           surface area cannot be defined – surface ratio should be preferred according to 
           Instructions)                                           ISO 10993-12)
           Dimensions/Weight:                                           
           Quantity Submitted***:                                           
                                                                      Sterile       Non Sterile     Sterilization process : Please choose one 
           Sterilization**:                                                                         If Other, please describe:                          
                                                                      NAMSA to sterilize (additional fee will apply)
           Storage Conditions**:                                   Please choose one
           Physical Description**:                                          
           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, cosmetic, biologic or medical device presented as a liquid, 
           powder, paste, 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.
           *** Pharmaceutical and cosmetic: at least one additional sample must be supplied and retained at NAMSA as sampling product for all the studies.
                                                                 Control Article Characterization
           NAMSA will specify when a sponsor-submitted control is necessary. NAMSA provides control for most routine studies. If you have 
           questions, please contact a NAMSA Technical Specialist at +33 (0)4 78 07 92 34.
           Control Article Stability before opening 
           packaging                                                                     Control Article Stability after opening packaging
               Stability testing is in progress and sponsor affirms that test
               article                                                                       Stability after opening packaging is:       Please choose one
               is stable for duration of intended testing.
               Stability testing is complete and on file with sponsor.
               Expiration Date (DD/MM/YYYY):   /  /                                          Stability after opening packaging is not applicable.
               Marketed product stability is characterized by its labeling.
               Expiration Date (DD/MM/YYYY):   /  /    
           Control Article Mixture Analysis                                              Control Article Homogeneity
               Analysis is not necessary because test article is a solid, 
               powder, gel, or liquid being extracted or being tested as                     Test article is a homogeneous gel, liquid or powder.
               received (will not be mixed with a carrier).
                                                                                             Test article is a non-homogeneous gel liquid or powder.
                                                                                             Instruction before use to assure homogeneity :      
               Sponsor will perform analysis on representative aliquots                      Homogeneity is not applicable because no sampling is 
               provided by NAMSA. Results must be provided to NAMSA.                         performed before testing or the test article is a solid.
           Page 3/4                                                                                                                     E-QUA 238v2 – 29/08/2011
                                                 GLP SAMPLE SUBMISSION FORM – With Control Article
                                                                                                                                           www.namsa.com
                                            Reminder (will automatically be fulfilled before printing)
            Control Article Name:                                Error: Reference source not found
            Control Article reference:                           Error: Reference source not found
            Control Article Identification:                      Enter Batch Code or Lot Number: Error: Reference source not found
                                                              Control Article Characterization
          Control Article Strength                           Control Article Purity                       Control Article Composition
              Strength is:                                       Purity is:          
              Strength is not applicable because no              Purity is not applicable because         Test article is composed of the following 
              active ingredients are used to formulate           the test article is a multi-             materials/ingredients:          
              a concentration.                                   component device.
                                                                 Control Article Disposition
          After testing, NAMSA should:
              Discard used & unused test article                                    *Method of Return Shipment
              Return unused test article (additional fees will be applied)*         Please choose one if applicable        Other:          
              Return used & unused test article (additional fees will be            Account #:      
          applied)*
          Please print this form and sign. Signature must be handwritten.
          Sponsor Signature:                                                       Date:
          Page 4/4                                                                                                                E-QUA 238v2 – 29/08/2011
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...Glp sample submission form with control article www namsa com instructions this must be completed electronically using microsoft word upon completion please print then sign and date it at the bottom include your ship to address that appears on cost estimate proposal if you have any questions contact a technical specialist thank for business information final report will mailed bill same as company name city state zip country phone accounts payable fax e mail number method of payment purchase order test reference identification enter batch code or lot can cut yes no cutting expose inner surfaces extraction vehicle surface area in cm conditions c hour hours recommends highest cytotoxicity only temperature not degrade other specify case condition is selected by sponsor automatically use unless specifically required thickness mm ratio ml applies solids liquid powder gel irregularly shaped objects option g place special cannot defined should preferred according iso dimensions weight quantit...

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