Note to Suppliers Completing This Questionnaire

Raw Material Technical 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

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.

Contents

Section 1:General Product Information

1.1 General Product Information

Section 2:Manufacturing, Packaging, Release Site and Supplier Information

2.1 Supply Chain Information

Section 3:Physiochemical Information

3.1 Physiochemical Information

Section 4: Regulatory Information

4.1 Health Authority Registration

4.2 Dedication of Equipment at Source Manufacturer

4.3 Dedication of Equipment at Re-packager

4.4 Origin of Material

4.5 Allergens/Hypersensitivity

4.6 Gluten-free Status of Material

4.7 Genetic Modified Organisms (GMO)

4.8 Residual Solvents (CPMP/ICH/283/95)

4.9 Elemental Impurities...... ……..………………………………………………………

4.10 Metal Catalyst and Metal Reagents

4.11 Certification(s) of Purity

4.12 Potential for Economic Adulteration

Section 5: Miscellaneous Product Information

5.1 Lot/Batch Definition

5.2 Technically Unavoidable Particles

5.3 Expiration

5.4 Storage and Shipping Conditions

5.5 Packaging Information

Section 6: Signature

Addendum: Adventitious Agents

A. Origin of Material

B. Adventitious Agents Risk Analysis Survey

B1. Production Details

B2. Material Details

C. Adventitious Agent Risk Analysis Survey

C1. Viral Treatment Barrier

C2. Viral Testing Barrier

Section 1:General Product Information

1.1 General Product Information

Product or Material Name / Click or tap here to enter text. /
Manufacturer’s Name / Click or tap here to enter text. /
Vendor’s Product Code / Click or tap here to enter text.
Product or Material Description / Click or tap here to enter text.
cGMP Material / ☐Yes ☐No
If yes, which cGMP standards are followed / ☐ISO 9001 ☐ISO13485 ☐CFR 820 ☐Other, please state
Click or tap here to enter text.
Contact for Technical Information for Product or Material (Name, Phone Number, e-mail) / Click or tap here to enter text. /

Section 2: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 / Click or tap here to enter text. /
Source Manufacturer Site(s)[1] / Click or tap here to enter text.
Further Processing Site. E.g. micronisation / Click or tap here to enter text. /
Repackaging Site(s) / Click or tap here to enter text.
Sterilization or Irradiation Site(s) / Click or tap here to enter text. /
Product Release Site(s) / Click or tap here to enter text. /
Warehouse/Long Term Storage Site(s) / Click or tap here to enter text. /
Testing Site(s), including stability testing locations, if different / Click or tap here to enter text.
Distributor(s)
List names and countries / Click or tap here to enter text.

Section 3: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:
Click or tap here to enter text.
Material Attributes / ☐ Light Sensitivity
☐ High Potency
☐ Moisture Sensitive; if yes explain:
☐ Air Sensitive; if yes explain:
☐ Other; Explain:
Click or tap here to enter text.
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) / Click or tap here to enter text. /
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? / Describe:Click or tap here to enter text.

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.
Click or tap here to enter text.
☐No
Compendial status / Please select all that apply:
☐No Compendium Exists
☐Non-compendial
☐USP / NF
☐FCC
☐EP/BP
☐JP
☐CP
☐Other: Explain:
Click or tap here to enter text.

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:
Click or tap here to enter text.
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:
Click or tap here to enter text.
4.4Origin 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:
Click or tap here to enter text.
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:
Click or tap here to enter text.
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:
Click or tap here to enter text.
4.5Allergens/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:
Click or tap here to enter text.
☐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:
Click or tap here to enter text.
☐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 separate, independently-controlled environment from the material’s manufacturing area? / ☐Yes ☐No ☐N/A: No Compounds Listed Above
Are sensitizers or preservatives (e.g., latex, shellfish, nuts, corn, wheat, antietc.) used in the manufacturing process? / ☐Yes; List:
Click or tap here to enter text.
☐No
Does the material potentially come into contact with any silicones, or are any included in the formulation of the material? / ☐Yes; List:
Click or tap here to enter text.
☐No
Does the material potentially come into contact with preservatives, or are any included in the formulation of the material? / ☐Yes; list:
Click or tap here to enter text.
☐No
Does the material potentially come into contact with natural latex, or is this included in the formulation of the material? / ☐Yes; List:
Click or tap here to enter text.
☐No
Are procedures in place which provides controls that allow no potential for cross contamination of any allergens or other products? / ☐Yes ☐No
4.6Gluten-free Status of Material Completion Not Required If Box Checked ☐
Are the materials of interest produced at this facility gluten-free? / ☐Yes ☐No ☐ Unknown
Has the gluten-free status of the material been certified by Quality Assurance international (QAI) or a similar organization? / ☐Yes; Provide a copy of the most recent certification:
☐No
(If YES, please provide a copy of the most recent certification)
4.7Genetic Modified Organisms (GMO) Completion Not Required If Box Checked ☐
Is this material genetically modified? / ☐Yes ☐No
Are Genetically Modified Materials or Organisms used in the manufacturing of, purification of, or other processing step of this material? / ☐Yes; List below:
☐No

4.8Residual Solvents (CPMP/ICH/283/95)

Completion Not Required If Box Checked ☐
Are solvents used or produced in the manufacturing of or purification of this material? / ☐Yes; List solvents:
Click or tap here to enter text.
☐No
Please check the Solvent Class as defined by EP 5.4 Residual Solvents. / ☐ Class 1
☐ Class 2
☐Class 3
☐ N/A: No solvents used or produced
Are Residual Solvents,as defined by EP 5.4 Residual Solvents, present in the material? / ☐Yes; To what level are the Residual Solvents present?
Click or tap here to enter text.
☐No
4.9Elemental Impurities (ICH Q3D and USP <232> ) Completion Not Required If Box Checked ☐
Identify if elemental impurities are (or are likely to be) present.
Elemental impurities include: Cd, Pb, As, Hg, Co, V, Ni, Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt, Li, Sb, Ba, Mo, Cu, Sn, Cr / ☐Yes; see question below.
☐No; please state rational why no elemental impurities are present (or refer to an attached document):
Click or tap here to enter text.
If likely to be present, identify expected concentration (or range), analytical method used and limit of detection, if known. Please note if any metals catalysts or reagents are intentionally used in the manufacturing process.
(The IPEC or company specific questionnaire for elemental impurities may be attached to answer this question) / Click or tap here to enter text. /

4.10Metal Catalyst and Metal Reagents

(EMEA/CHMP/SWP/4446/2000) Completion Not Required If Box Checked ☐
Are Metal Catalysts or Metal Reagents used or produced in the manufacturing of or purification of this material? / ☐Yes; List:
Click or tap here to enter text.
☐No
Are residues of Metal Catalysts or Metal Reagents, as defined by EP 5.20 Metal Catalyst or Metal Reagent Residues, present in the material? / ☐Yes;

1. What level are the Metal Catalysts or Metal Reagents present?
Click or tap here to enter text.

1. Is this on the CoA?

Click or tap here to enter text.

1. Is testing performed on every batch? What testing methodology is used?
Click or tap here to enter text.

☐No
4.11 Certification(s) of Purity Completion Not Required If Box Checked ☐
Does the material produced at this facility conform to the regulations of kashrut (Jewish dietary law) or Halal status? / ☐Kosher ☐Halal ☐Neither
Which authority certifies the Kosher or Halal status of the material produced at this facility? / Click or tap here to enter text.
(Please provide a copy of the most recent certification)
Is the material produced at this facility considered to be organic? / ☐Yes ☐No
Which authority certifies the organic purity status of the material produced at this facility? / Click or tap here to enter text.
(Please provide a copy of the most recent certification)
Does your material contain phthalates or are phthalates used/produced in any step of the production process? / ☐Yes ☐No
If yes, please specify and also state the concentration
Click or tap here to enter text.
Does your material contain gelatin used/produced in any step of the production process? / ☐Yes ☐No
If yes, please specify and also state the concentration
Click or tap here to enter text.
Does your material contain beta glucan used/produced in any step of the production process? / ☐Yes ☐No
If yes, please specify and also state the concentration
Click or tap here to enter text.
4.12Potential for Economic Adulteration Completion Not Required If Box Checked ☐
What controls are in place to assure that the materials produced at or shipped from this facility are not adulterated, e.g.melamine, PEG, Jatropha, etc? / ☐Yes; Explain:
Click or tap here to enter text.
☐None
Is the material supplied at risk for melamine contamination (FDA guidance - Pharmaceutical components at risk for melamine contamination)
If yes, which measures are in place to monitor its absence in the material supplied? / ☐Yes; Explain:
Click or tap here to enter text.
☐None

Section 5: Miscellaneous Product Information

5.1 Lot/Batch Definition Completion Not Required If Box Checked ☐
Does the lot/batch number follow a specific format that implies additional information (e.g., first 2 digits represent month of manufacture, etc.)? / ☐Yes; Explain:
Click or tap here to enter text.
☐No
Definition of a lot/batch / ☐Time frame within continuous processing
☐Unique lot/batch production
☐Per final package fill
☐Other; Explain:
Click or tap here to enter text.
Minimum Lot/Batch Size / Click or tap here to enter text. /
Maximum Lot/Batch Size / Click or tap here to enter text. /
5.2 Technically Unavoidable Particles Completion Not Required If Box Checked ☐
Has an assessment been performed for technically unavoidable/inherent particles? / ☐Yes; Explain:
Click or tap here to enter text.
☐No
Please list (or attach) a list of materials that are technically unavoidable particles: / Click or tap here to enter text. /
5.3 Expiration (see IPEC Stability Guide) Completion Not Required If Box Checked ☐
Suggested Expiration Period /
Re-evaluation Interval / Click or tap here to enter text.
Expiry Basis / ☐Date of Manufacture
☐Date of Repackaging
☐Date of Quality Release
☐Other; Explain:
Click or tap here to enter text.
Expiration or Shelf LifeData / ☐Attached
☐Only Available During Audit
☐Not Available
Is there an ongoing stability monitoring program in place? / ☐Yes ☐No
If yes, please specify frequency, e.g., one lot per year.
Click or tap here to enter text.
Temperature & Humidity Excursion Data / ☐Attached
☐Only Available During Audit
☐Not Available
5.4 Storage and Shipping Conditions Completion Not Required If Box Checked ☐
Storage Conditions / ☐Ambient
☐Controlled Room Temperature (20°C to 25°C)
☐2-8°C
☐-20°C
☐-70°C
☐Protect from light
☐Protect from moisture
☐Other; Explain:
Click or tap here to enter text.
Shipping Conditions / ☐Ambient
☐Cold
☐Frozen
☐Other; Explain:
Click or tap here to enter text.
5.5 PackagingInformation Completion Not Required If Box Checked ☐
For materials repackaged within the supply chain, is the original packaging different than the final packaging configuration(s)? / ☐Yes; Provide original packaging description below:
Click or tap here to enter text.
☐No
☐N/A: Product not repackaged
What is the size of the final packaging configuration(s)? / Click or tap here to enter text. /
What is the material of construction of the final packaging configuration (e.g., pail/ drum/container/tanker)? / ☐HDPE
☐Stainless Steel
☐Glass; Provide the type and grade:
Click or tap here to enter text.
☐Other; Explain:
Click or tap here to enter text.
What is the material of construction of the final packaging configuration lid? / ☐HDPE
☐Polypropylene
☐Fiber
☐Other; Explain:
Click or tap here to enter text.
What is the material of construction of the liner in the final packaging configuration? / ☐HDPE
☐LDPE/LLDPE
☐Paper/Crape
☐No Liner
☐Other; Explain:
Click or tap here to enter text.
Does the packaging include any slip agents? / ☐Yes; Specify:
Click or tap here to enter text.
☐No
Are desiccant packs used in the final packaging configuration? / ☐Yes ☐No
Does the material’s packaging contain tamper evidence devices? / ☐Yes, Explain:
Click or tap here to enter text.
☐No
Are there any other special packaging configuration requirements/ specifications? / ☐Nitrogen blanket
☐Pressurized
☐Other, Explain:
Click or tap here to enter text.
Are the final packaging configuration reusable/refurbished? / ☐Yes ☐No
For products delivered in bulk tankers, are any special hook-ups required? / ☐Yes; Explain the special hook-up required:
Click or tap here to enter text.
☐No
☐N/A: Not delivered in bulk tanker
Provide a sample label / ☐Picture attached
☐Sample label attached
Provide a sample Certificate of Analysis / ☐Sample Certificate of Analysis attached
Provide an MSDS / ☐MSDS attached

Section 6: Signature

NAME:Click or tap here to enter text.
TITLE:Click or tap here to enter text.
PHONE:Click or tap here to enter text.
E-MAIL ADDRESS:Click or tap here to enter text.
EMPLOYER:Click or tap here to enter text.
SIGNATURE:
DATE:Click or tap here to enter text.

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© Biophorum Operations Group Ltd

Raw Material Technical Questionnaire

Addendum: Adventitious Agents

Our proposal is to remove this section and refer people to Module 3 Section 6 of the RX 360 Questionnaire.

A.Origin of Material

In case the questionnaire covers more than one product, please use a separate form for each product.
Product Name / Product Code
Click or tap here to enter text. / Click or tap here to enter text. /
Does the product involve the use of non-synthetic materials (i.e. Plant, Animal or Human Origin)? / ☐Yes
☐No
Is the manufacturing facility an animal free facility? / ☐Yes ☐No