Supplier Questionnaire
Note to Suppliers Completing this Questionnaire:
Thank you for agreeing to complete this questionnaire.
The intent is to obtain required fundamental technical information, which biopharmaceutical manufacturer require to assure the quality of the medicines they produce and to fulfill their regulatory requirements.
A user guide to help you complete the questionnaire is also available at http://www.biophorum.com/article/164/raw-material-technical-questionnaire
Please complete all required sections. Sections that are not required will be marked in the section header: Completion Not Required If Box Checked
Once you have completed the questionnaire,
please send a completed copy to the requesting organization
retain a copy in your records, should another bio-pharmaceutical organisation request that you complete the questionnaire for the same material, you can send them a copy of the previously completed questionnaire.
If you have any questions regarding the questionnaire, please contact the requestor.
In some cases specific organizations may request further information in the form of addendum, this will have already been sent to you.
ContentsSection 1:General Product Information41.1 General Product Information4Section 2:Manufacturing, Packaging, Release Site and Supplier Information52.1 Supply Chain Information5Section 3:Physiochemical Information63.1 Physiochemical Information6Section 4: Regulatory Information74.1 Health Authority Registration74.2 Dedication of Equipment at Source Manufacturer74.3 Dedication of Equipment at Re-packager74.4 Origin of Material84.5 Allergens/Hypersensitivity94.6 Gluten-free Status of Material104.7 Genetic Modified Organisms (GMO)104.8 Residual Solvents (CPMP/ICH/283/95)10 4.9 Elemental Impurities.......................................... 114.10 Metal Catalyst and Metal Reagents114.11 Certification(s) of Purity124.12 Potential for Economic Adulteration12Section 5: Miscellaneous Product Information135.1 Lot/Batch Definition135.2 Technically Unavoidable Particles135.3 Expiration145.4 Storage and Shipping Conditions145.5 Packaging Information15Section 6: Signature17Addendum: Adventitious Agents1A. Origin of Material2B. Adventitious Agents Risk Analysis Survey2B1. Production Details2B2. Material Details4C. Adventitious Agent Risk Analysis Survey5C1. Viral Treatment Barrier5C2. Viral Testing Barrier6
General Product Information
1.1 General Product Information
Product or Material Name
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Manufacturers Name
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Vendors Product Code
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Product or Material Description
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cGMP Material
Yes No
If yes, which cGMP standards are followed
ISO 9001 ISO13485 CFR 820 Other, please state
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Contact for Technical Information for Product or Material (Name, Phone Number, e-mail)
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Manufacturing, Packaging, Release Site and Supplier Information
Additions can be made to this section, e.g. adding a Crude Source Manufacturer row. However, no deletions should be made. Mark any sections that are not applicable with N/A.
2.1 Supply Chain Information Completion Not Required If Box Checked ldj
Names and Locations of Sites Please include all sites
Site Addresses and Named Contact for each site.
Crude Source Manufacturer Site
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Source Manufacturer Site(s)[footnoteRef:1] [1: Disclosure of full supply chain is necessary including the original manufacturer see guidance notes.]
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Further Processing Site. E.g. micronisation
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Repackaging Site(s)
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Sterilization or Irradiation Site(s)
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Product Release Site(s)
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Warehouse/Long Term Storage Site(s)
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Testing Site(s), including stability testing locations, if different
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Distributor(s)
List names and countries
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Physiochemical Information
3.1 Physiochemical Information Completion Not Required If Box Checked
CAS number
N/A
Material Origin
Chemical Synthesis
Animal
Plant
Mineral
Bacterial / Microbial
Human Origin
Other; Explain:
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Material Attributes
Light Sensitivity
High Potency
Moisture Sensitive; if yes explain:
Air Sensitive; if yes explain:
Other; Explain:
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Brief Description of Manufacture
(Blend, Reaction, Continuous / Batch Process, etc.) including list of critical equipment, critical process parameters and in-process testing. Please provide a process flow diagram (from starting materials through end product or material)
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Does this product consist of more than one independent component (e.g., buffer, culture media, mixed excipient, co-processed excipient, etc.)
Yes; Explain: Click or tap here to enter text.
No
What measures are taken to ensure appropriate product composition?
Describe:Click or tap here to enter text.
Any known impurities of product or incoming raw materials?
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Section 4: Regulatory Information
4.1 Health Authority Registration Completion Not Required If Box Checked
Do you maintain a DMF for the products contained here that you will authorize the customer to reference in an application and the FDA to review when reviewing an application filed by the customer?
Yes; List the Drug Master File Number below.
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No
Compendial status
Please select all that apply:
No Compendium Exists
Non-compendial
USP / NF
FCC
EP/BP
JP
CP
Other: Explain:
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4.2 Dedication of Equipment at Source Manufacturer
Is the material manufactured on product-dedicated equipment?
Yes
No; Explain below what other materials are processed on the same equipment and how cross-contamination prevented:
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Is the material packed on product-dedicated equipment?
Yes No
4.3 Dedication of Equipment at Re-packager
Is the material repackaged on product-dedicated equipment?
Yes
No; Explain what other materials are produced on the same equipment and how cross-contamination is prevented:
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4.4 Origin of Material Completion Not Required If Box Checked
Does the product involve the use of non-synthetic materials (i.e. Plant, Animal, Human Origin, or other biological e.g. microbial fermentation)?
Yes; Please complete this form, plus Adventitious Agents Addendum
No; Please complete this form only
Dedication of Equipment at Source Manufacturer:
Is the material manufactured on product-dedicated equipment?
Yes
No; Explain below what other materials are processed on the same equipment and how cross-contamination prevented:
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Is the material packed on product-dedicated equipment?
Yes No
Dedication of Equipment at Re-Packager:
Is the material repackaged on product-dedicated equipment?
Yes
No; Explain what other materials are produced on the same equipment and how cross-contamination is prevented:
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Is any of the Equipment used for processing or storage of the product (at the manufacturing site or repackaging site) in contact at any time with other materials of animal origin?
Yes No
Describe Equipment cleaning and effectiveness to prevent against Adventitious Agent cross contamination (a separate memo may be provided if more space is needed). N/A is only appropriate if the facility is animal free.
Describe:
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4.5 Allergens/Hypersensitivity (Food Allergen Labeling and Consumer Protection Act of 2004 [FALCPA]) Completion Not Required If Box Checked
Are Allergens as described in the Food Allergen Labeling and Consumer Protection Act of 2004 used in the manufacturing of this material?
Refer to EP guidance? Yes
Yes; List:
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No
Have Allergens as described in the Food Allergen Labeling and Consumer Protection Act of 2004 been used/manufactured in the facility?
Include references
Yes; List:
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No
Are the above listed compounds stored in a warehouse along with the material?
Yes No N/A: No Compounds Listed Above
Does equipment used to manufacture the material come into contact with the above compounds?
Yes No N/A: No Compounds Listed Above
Are the compounds listed above manufactured in a
