West The Source™ 
 
 
Product Requirement Questionnaire 
* Required information
* Company Name:    * Contact Name:   
* Street Address:    * Phone:   
* City:    Fax:
State:   * Email:
* Zip:    * Date:   
Drug Product Details
1.) Generic name of product:
2.) Chemical name of active ingredient:
 
3.) Market Segment(s):
Pharma Biotech Vet. Pharma Vet. Biotech Contract
Generic Dental Diagnostic Medical Dev.  
 
4.) Therapeutic Category (e.g., oncology, infectious disease, etc.):
 
5.) Details of Solvent Vehicle:
 
6.) Preservative (type and amount or % used):
 
7.) Stabilizer:
 
8.) pH of solution:
     Liquid:
     Powder Fill:
     Lyophilzation:
              If yes for Lyophilization:
                Cake weight:
                Cake moisture specification:
 
9.) Buffer system:
 
10.) Antioxidant (chemical and amount or % used):
 
11.) Sensitive to metallic ions?
          If yes, what metals?
 
12.)Other known sensitivities?
 
13.) Route of Administration (e.g., intramuscular, subcutaneous, etc.)
 
14.) Requirements for packaging under vacuum

Packaging Details
Package description (Initial package and potential future packaging.)

1.) Container size: Fill volumes:
 
Vials
US GPI ISO/DIN Other (Attach Drawing)
1.) Nominal Stopper Size: 13 mm 20mm 28mm 32mm Other:
 
2.) Neck ID Spec (please attach a copy of the drawing):
 
3.) Functional application:
Spike (in./mm) Needle (ga.) Blunt cannula (ga.)
Single Dose: Multi-Dose:
          If multi-dose, number of doses/punctures:
 
Syringe  
1.) Pre-filled syringe ID:
 
2.) Dental Cartridge or Syringe/Cartridge System (describe)
 
3.) Needle shield: Tip cap:
Customer's Processing Parameters
Method of Sterilization:
Aseptic Terminal Both Aseptic and Terminal
Steam Temperature � C      Time min.
Ethylene Oxide
Gamma     Dose kGv
None – Require Sterile Product – Ready-to-Use
 
Typical/Anticipated process cycle
Temperature of storage
Filling Location: In House   Contract Filler   Name/Location
Customer Intended global market segments   (Check all that apply)
     U.S.      Europe      Asia      Japan     Other
     Customer Pharmacopia requirements (rubber closures)
     U.S.P.    Ph.Eur        J.P.        Other
     Customer Site of Manufacture
     U.S.      Europe      Asia      Japan     Other
Are there any known chemical or functional problems that exist today on current packaging systems?
     If yes, explain:
Project Timeline
(Please list estimated dates that West Pharmaceutical Services' Products will be required)
Experimental Samples
Qualification Samples
Production Samples
Expected Purchase Figures per year
Drug Product Phase
I      II      III      On Market
Critical Quality Attributes
Lot-by-Lot Extractable Data
Vision Inspected Stoppers
Subvisible Particle Specification
Additional comments:
Are you ready to submit this information?
   
 
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