RMVQ New format
RFI Ingredients, Inc. Raw Material Vendor Questionnaire
Product Name/Description Dicalcium Phosphate Dihydrate Dicalcium Phosphate Anhydrous
RFI Product Code Filled by RFI Internal
1 This Raw Material Vendor Questionnaire (RMVQ) is used as part of our raw material approval process. The material name must be referenced above and is either being considered for purchase, or it currently purchased.
2 Please provide complete answers for all questions and return promptly, for evaluation by our Quality Assurance Department within 2 weeks of receipt.
3
Do not leave blank spaces, if a question does not apply, please write "N/A" (Not applicable) or a statement clearly mentioning the reason.
4 Each sample or shipment supplied to RFI for evaluation or for internal use must accompany COA, if not the material will be rejected at vendor's expense.
Material Identification
1 Vendor/Supplier Name Filled by Vendor/Trading Company
2 Vendor Raw Material Name Filled by Vendor/Trading Company
3 Vendor Raw Material
Identification Number
Filled by Vendor/Trading Company
4 Manufacturer(s) Raw Material
Identification Number
Filled by Manufacturer
5 Raw Material Manufacturer(s) Filled by Manufacturer 6
Address(s) of Manufacture Filled by Manufacturer 7
For new product evaluation, please provide:
a. Sample of at least 200g from 3 different lots
b. Certificate of Analysis (COA) of each sample
Raw Material Vendor Questionnaire
This raw material is classified as a
Food Y
Drug N Nutritional Supplement Y
Compendium or Classification 1 CFR Monograph N Section:
2 U.S. Pharmacopeia (USP) Y
3 National Formulary (NF) Y
4
Food Chemicals Codex
(FCC)
Y
5 U.S. Dietary Ingredient Y
6
U.S. New Dietary
Ingredient
Y
7 Current Specification Please attach
8
Current Material Safety
Data Sheet (MSDS)
Please attach
9 Example of COA Please attach
10 Non-GMO Y
11 Organic □NOP □EC □JAS
12 Organic Complaint Letter Please provide a statement
13 Kosher Please attach
14 Halal Please attach
15 IP Statement/Certificate Please attach
16 Allergen Statement Please fill up the Allergen Letter
17 Non Irradiation Y
18 Non ETO Treated Y
19
Product Continuing
Guarantee
Please provide a statement
20 Shelf Life Study □Complete □In progress
21 Vegan Y
22 Vegetarian Y
23 Free from BSE/TSE Y
24 Nutritional Information Please attach
Compendium or Classification 25 Heavy Metal Test Report (As, Pb, Hg, Cd, Cr VI)
Please attach 26 Aflatoxin Test Report (B1, B2, G1, G2)
Please attach 27
Pesticides Residual Test Report
Please attach
28 Melamine Free Y 29 BPA Free
Y 30
Other (Please specify)
31 32
State the physical characteristics of the material including general appearance, color, odor, form, and taste
Forward any clinical studies completed on this material, if
not previously provided
Lead time for orders (days) Standard package size Minimum order quantity
For Vitamins, Minerals, Nutritionals, Excipients, Flavors, and Colors
State the chemical name (s) State the CAS registry number (s) What is the empirical and structural formula What is the molecular weight State the water of hydration, on molecular basis Is the raw material a blend, or a pure substance
General Information of Material Is this raw material from a natrual source What is this raw material derived from State the country/countries of origin of this material
For Botanicals
State the Latin Binomial/Name
State the plant part used
State the drug:
i. Native extract ratio (without excipients/carriers)
ii. Extract ration (with excipients/carriers)
For Enzymes and Glandular (or other animal-derived) Materials What is the raw material derived from
If animal origin, state animal type (Bovine, porcine,
sheep, poultry, etc.)
If anumal is cattle, bison, deer, elk, goat, or sheep, state
the age range in months
Provide BSE preventative information (Veterinary
certificates, countries of origin, slaughter, and processing,
etc.)
Manufacturing Processing
Please attach the processing flow chart of this product
(with details added such as processing aids and solvent
used, temeprature and pressure involved, and etc. to
verify product naturalness
Manufacturing processing involves
i. Chemical synthesis Y/N
ii. Extraction/Purification Y/N
iii. Blend Y/N
List any reagents and solvents used
Do you test for residual solvents used in the
Y/N manufacturing process?
If yes,
i. What do you test for?
ii. What is the specification limit?
Product Security:
Is tamper evident packaging used? Y/N
Metal Detection:
Do you have metal detectors on lines on which products
Y/N are produced for RFI?
Please state the sensitivity:
i. Stainless steel (mm)
ii. Ferrous (mm)
iii. Non-ferrous (mm)
Is testing documented? Y/N Is the reject mechanism tested and documented? Y/N
Magnets:
Do you have magnets on lines on which products are
Y/N produced fpr RFI?
i. Frequency of testing
ii. Is testing documented Y/N Sifting/Screening:
Do you have screen on lines which products are produced
Y/N for RFI?
i. Frequency of testing
ii. Is testing documented Y/N
Are there any other product protection devices in place
Y/N (eg.: X-ray, etc.) on all RFI lines?
If yes, please specify
What sanitizing compound is used on the equipment and
at what percentage (%)?
Labeling State exactly how RFI ingredients, inc., should label this material:
Additional Ingredients
Carriers Ingredient
Present Source
Added
Amount
(%)
Excipients
Flavors
If yes,
i. Natural
ii. Artificial
Colors
If yes,
i. Natural
ii. Artificial
Sugars (eg. fructose, sucrose, lactose, etc.) Sodium Chloride
Antioxidants and/or preservatives Sulfites and/or sulfur
MSG
Other (Please specify)
Nutritional Information
Nutritional Component Amount
per 100g
Test Method
(Calculation/Analytical)
Total calories
Calories from fats Total Fats
Saturated fats
Polyunsaturated fats
Monounsaturated fats
Trans fats Cholesterol
Sodium
Potassium
Total Carbohydrates
Dietary fiber
Soluble fiber
Insoluble fiber Sugar
Sugar alcohol
Protein
Vitamin A
Vitamin C
Calcium
Iron
Other (Please specify)
Testing and Assays
Test Frequency Raw material identification
i. If TLC is used, provide method
ii. If HPLC is used, provide
a) Method
b) Chromatogram for Reference Standard
c) Chromatogram for Raw Material
iii. If FTIR is used, provde method
Key component (s)
i. If HPLC is used, provide
a) Method
b) Supplier Name of Reference Standard
c) Standard Purity
d) Chromatogram for Reference Standard
e) Chromatogram for Raw Material
ii. If UV is used, provide
a) Method
b) Supplier Name of Reference Standard
c) Reference Standard Purity
d) Calculation (Formula)
iii. State if result is "wet based" or "dry based"
Moisture
a) Specification
b) Frequency
c) Time
d) Temperature
Particle size
a) Mesh size (Through 80%)
b) Mesh size (Through 95%)
c) Mesh size (Through 100%) Microbiological Analysis
a) Aerobic Plate Count (APC)
i) Specification (cfu/g)
iii) Frequency
iii) Method used
b) Yeast and mould
i) Specification (cfu/g)
iii) Frequency
iii) Method used
c) Coliforms
i) Specification (cfu/g)
iii) Frequency
iii) Method used
d) E.coli
i) Specification (cfu/g)
iii) Frequency
iii) Method used
e) Salmonella
i) Specification (cfu/g)
iii) Frequency
iii) Method used
f) Staphylococcus aureus
i) Specification (cfu/g)
iii) Frequency
iii) Method used
Other (Please specify)
Pesticides
i) Specification
ii) Frequency
iii) Method used Aflatoxins (B1, B2, G1, G2)
i) Specification
ii) Frequency
iii) Method used
Heavy Metals
a) Arsenic (As)
i) Specification (ppm)
i) Frequency
iii) Method used
b) Lead (Pb)
i) Specification (ppm)
i) Frequency
iii) Method used
c) Mercury (Hg)
i) Specification (ppm)
i) Frequency
iii) Method used
d) Cadmium (Cd)
i) Specification (ppm)
i) Frequency
iii) Method used
e) Chromium 6 (Cr IV)
i) Specification (ppm)
i) Frequency
iii) Method used
If chemical sterilizers are used? Y/N Do you test for residual level? Y/N If yes, state the maximum allowable limit for each
compound
Do you test for pesticide, herbicide, fungicide, fertilizer,
Y/N or any other agrochemical residuals that may be present
in the material
If yes, please specify the maximum allowable level for
each component
Shelf Life and Stability 1 State the recommended storage condition of this material
2 State the shelf life of this material under condition above *Please attach the stability test report if available
3 State the expected percentage (%) degration of the key compound (s), under the condition above as this material
is packaged
Packaging and Shipping Requirement
1 The material shall be packaged in a manner which ensures maximum product stability
2 The material shall be contained in well-closed containers that protect the contents from adulteration and loss of material, under ordinary conditions of handling, shipping, storage, and distribution
3 Packaging materials shall conform to all cGMP regulations
4 Within the promary shipping container, the material shall be double-bagged and sealed with a non-metallic closure
5 Metal twist ties or staples are not accepted
6 Bags should be composed of food grade materials and either polyethylene (minimum of 2 mm) or poly-lined foil
7 Desiccants, if used, must not come in direct contact with the material
8 Styrofoam and packing peanuts are not acceptable in the packaging of raw material
Packaging Configuration of the Product
1 Type of container
2 Package size (s) available in kg
3 Use of deciccants (must also be noted on the outside of the shipping container)
4 Acceptable storage temperature range
5 Special handling precautions (in regards to exposure to light, moisture (% RH), etc.)
As a part of cGMP we require our vendor to fill the RMVQ every 3 years and after submission of documentation. If any part of the manufacturing process is altered in a manner that would change this raw material (eg. Excipient/carrier, change in allergen status, etc.) you will be responsible for notifying RFI Ingredients, Inc. of these changes and resubmit the questionnaire.
Name (Printed): _______________________________
Title: _____________________________
Signature: _________________________
Date: _____________________
Company Name: __________________________________________(Please provide your company stamp) Tel: _____________________________
Fax: _____________________________
Email: ___________________________
Technical contact person information:
Same as above (Y/N)
If not, please fill up the information below:
Name (Printed): _______________________________
Title: _____________________________
Tel: _____________________________
Email: ___________________________
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