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ASG Raw Inventory
ASG Packaging
🏷 Labels
Customer Raw Inventory
Customer Packaging
Customer Premix
ASG Raw Inventory
SP — Dietary Supplements
158 items▼
CL — Carrier Liquids
22 items▼
AC — Active Cannabinoids
25 items▼
TR — Terpenes
8 items▼
GB — Gelatin / Shell
6 items▼
MI — MISC Ingredients
18 items▼
Formulations (MMR)
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Vendor Qualification
§111.75 / QA-006 Supplier Qualification Required
All vendors supplying raw materials must complete VQ qualification before first purchase.Vendor Qualification Register
| VENDOR | COMPONENTS SUPPLIED | GRADE | SCORE | STATUS | QUALIFIED BY | DATE | DOCUMENTS | ACTIONS |
|---|---|---|---|---|---|---|---|---|
| No vendors qualified yet — complete the VQ Questionnaire to add vendors | ||||||||
⛔ Rejected / Disqualified Suppliers
| VENDOR | COMPONENTS | REASON / NOTE | ACTIONS |
|---|---|---|---|
| No rejected suppliers. | |||
Vendor Qualification Questionnaire
Supplier Qualification Questionnaire. Complete all sections and attach current copies of any certifications/licenses/registrations referenced in Section 4. Sections 5, 8, and 9 apply only if relevant to your role (see Section 2). Yes/No answers are scored and reviewed by QA; all vendors supplying materials must be approved prior to first purchase (§111.75 / cGMP Supplier Qualification).
1. Company Information
Company Name
Supplier Type
Date Established
Company Address
Warehouse Location
Company Size
Annual Sales
Contact Information
Website
Components Supplied to ASI
Click to select component IDs…
Completed By / Title
Date Completed
2. Business & Distribution Profile
Your answers here determine which sections apply. Sections 5, 8, and 9 apply only if relevant to your role.
Do you take physical possession and title of the product (as opposed to a drop-ship or broker arrangement)?
YesNoN/A
Number and location(s) of your warehouse/distribution facilities:
States/countries in which you are licensed or registered to distribute dietary supplements (if applicable):
List the dietary supplement brands/product lines you distribute to us:
3. Regulatory Compliance & Registration
Is your facility registered with the FDA under the Food Safety Modernization Act? If yes, provide the registration number in Section 4.
YesNoN/A
Does your company comply with the applicable provisions of 21 CFR Part 111 or Part 117 for the operations you perform?
YesNoN/A
If you hold or distribute dietary supplements, do you comply with 21 CFR 111 Subpart M (Holding & Distributing)?
YesNoN/A
If your company’s name appears on the product label, do you comply with the full manufacturing, packaging, and labeling requirements of 21 CFR 111?
YesNoN/A
Are you licensed/registered as a wholesale distributor in the state(s) where you operate, where required?
YesNoN/A
Has your company or facility been subject to an FDA inspection, Form 483, Warning Letter, or product recall in the last 5 years?
YesNoN/A
Does your company undergo third-party GMP, quality, or customer audits?
YesNoN/A
Is there a documented process for customer complaint handling and adverse event reporting?
YesNoN/A
4. Certifications, Registrations & Licenses
List all that apply and attach a current copy of each certificate/license/registration with this form.
| Certification / Registration | Certifying Body & Cert/License # | Expiration |
|---|---|---|
| FDA Facility Registration | ||
| cGMP Certification | ||
| NSF/ANSI (e.g., 173, Certified for Sport) | ||
| USP Verified Mark | ||
| ISO (e.g., 9001, 17025, 22000, 14001) | ||
| GFSI-Recognized (SQF, BRCGS, FSSC 22000) | ||
| Organic (USDA NOP) | ||
| Kosher | ||
| Halal | ||
| Non-GMO Project Verified | ||
| State Wholesale Distributor / Business License | ||
| Certificate of Insurance / Product Liability | ||
| Other (specify) | ||
| Other (specify) |
5. Holding, Storage & Distribution Controls
Complete if you warehouse or hold product.
Are written SOPs maintained for holding and distributing operations?
YesNoN/A
Are environmental controls (temperature, humidity, light) maintained and monitored in storage/warehouse areas?
YesNoN/A
Is there an active pest control program for the facility?
YesNoN/A
Is there a segregated, identified quarantine area for rejected, non-conforming, or returned product?
YesNoN/A
Do you use a FIFO or lot-rotation inventory system?
YesNoN/A
Are security measures in place to prevent tampering, diversion, or entry of counterfeit product?
YesNoN/A
6. Receiving, Inspection & Traceability
Is there a documented receiving-inspection process (PO match, container integrity, labeling accuracy) on receipt from the manufacturer?
YesNoN/A
Is lot-to-lot traceability maintained from the originating manufacturer through to shipment to your customer?
YesNoN/A
Do you verify the upstream manufacturer’s cGMP status and obtain COAs before accepting product?
YesNoN/A
Do you maintain an approved supplier/vendor qualification program for the manufacturers you source from?
YesNoN/A
7. Returned Product, Complaints & Adverse Event Reporting
Are there written procedures for handling returned dietary supplements (quarantine, evaluation, disposition)?
YesNoN/A
Is there a documented process for receiving, reviewing, and investigating product complaints?
YesNoN/A
If your company’s name appears on the label, do you report serious adverse events to FDA within 15 business days?
YesNoN/A
Is there a written recall procedure, and has a mock recall been conducted in the last 12 months?
YesNoN/A
8. Manufacturing & Testing
Complete only if you manufacture, formulate, process, or test product.
Do you manufacture, formulate, or process the dietary supplements you supply (rather than sourcing finished, packaged product)?
YesNoN/A
Are written SOPs maintained for all production, packaging, and testing processes?
YesNoN/A
Does the facility maintain a Master Manufacturing Record and Batch Production Record for each product?
YesNoN/A
Do you test incoming raw materials/components for identity, purity, strength, and composition before use?
YesNoN/A
Do you test raw materials for heavy metals (lead, cadmium, arsenic, mercury)?
YesNoN/A
Do you test raw materials for microbial contamination (pathogens, TPC, yeast/mold)?
YesNoN/A
Do you test raw materials for pesticides, mycotoxins, and residual solvents, as applicable?
YesNoN/A
Do you test/verify that the finished product meets label claim (identity, strength, composition, potency) before release?
YesNoN/A
Are your testing laboratories ISO/IEC 17025 accredited?
YesNoN/A
Do you provide a Certificate of Analysis (COA) for each lot supplied?
YesNoN/A
Does the facility have a documented Environmental Monitoring Program?
YesNoN/A
Does the facility have a written Allergen Control Plan?
YesNoN/A
Are tests performed in-house, by a third-party lab, or both? If third-party, provide lab name(s) and accreditation:
Describe your raw material receiving, inspection, and approval process:
Describe your finished product release process, including who holds final QA release authority:
How are deviations, out-of-specification (OOS) results, and CAPAs handled?
9. Packaging, Labeling & Repackaging
Complete only if applicable to your operations.
Do you repackage, relabel, or private label any product?
YesNoN/A
Is packaging tamper-evident and compliant with applicable dietary supplement packaging standards?
YesNoN/A
If you repackage/relabel/private label, describe your labeling & packaging controls and how you ensure label claims match approved specs:
10. Records & Quality Systems
Do you maintain a documented Quality Management System (QMS) covering your operations?
YesNoN/A
Are records retained at least 1 year past shelf life (or 2 years from distribution of the last batch), per 21 CFR 111 recordkeeping?
YesNoN/A
Are personnel trained on GMP, allergen, and safety procedures relevant to their role?
YesNoN/A
11. Insurance & Business Documentation
Insurance Carrier
Product Liability Coverage Amount
Certificate of Insurance Expiration
State Distributor / Business License #
Production Orders
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Planning & Schedule
📋 To Schedule
Pick the rooms each order runs through, then schedule what's still open. Open the Calendar to see the timeline.
Production Calendar
All Activities
Gelatin
Blending
Blending 2
Encapsulation
Sorting
Packaging
SUN
MON
TUE
WED
THU
FRI
SAT
Production Floor
Pick your station to see the lots still needing work there, then log the record. Everything ties to the lot's BPR.
Gelatin Batching
Reports
📊 Monthly Owner Report
A printable month-in-review for ownership: spend, material cost & waste, room utilization & downtime, quality.
Consumption & Forecast
Lot Traceability
Trace Search
Type a Component ID to see the full life of an ingredient/packaging — where it was received from and every batch & product it went into with dates. Type a specific lot number to trace just that lot. Type a batch lot to see everything that went into it.
Enter a Component ID, lot number, or batch lot and click Trace.
Lot Folder — FDA Audit Package
Select Production Order / Lot
Assembles everything tied to one lot — batch record, finished-product & premix COAs, every ingredient & packaging COA and spec sheet, vendors used, QA disposition, deviations, in-process checks and reserve-sample records — into one printable, FDA-ready package.
Select a production order above to open its Lot Folder.
🔔 QA Release Alerts
In-Process Controls
🌡 Environmental Controls
Release Testing (LAB-002)
OOS / Deviations (LAB-004)
Stability (LAB-003)
Select an active production order to log in-process checks. Results are recorded against the BPR. Temperature, humidity and other facility checks now live under the Environmental Controls tab.
Select Active Order
SOP Library — American Softgels, Inc.
DOC-001
Record Retention, Retrieval & Archival
Quality§111.605–625Rev 00American Softgels, Inc.
1.0 Purpose
Click any SOP on the left to view its full content.
2.0 Scope
—
3.0 Responsibilities
—
5.0 Procedure
—
6.0 Records Generated
—
7.0 References
—
21 CFR Part 111 — Compliance
Subpart C — Physical Plant (§111.15–20)
§111.15
Facility sanitation
FAC-001 on file
§111.15
Pest control
FAC-002 on file
§111.15
Environmental monitoring
FAC-006 on file
Subpart D — Equipment (§111.25–35)
§111.25
Equipment cleaning
FAC-003 on file
§111.25
Preventive maintenance
FAC-005 on file
§111.27
Instrument calibration
FAC-004 on file
§111.35
Utilities qualification
FAC-007 on file
Subpart E — Components & Testing (§111.70–80)
§111.70
Component specifications
4 MMRs on file
§111.75
Identity testing — 100% lots required
LAB-001 / MAT-003 in place. 0 of 11 RM lots tested. BLOCKING.
§111.75
Reference standards management
LAB-005 on file
§111.27
Lab equipment qualification
LAB-006 on file
Subpart G–J — Production, Lab & Records
§111.260
Master Manufacturing Records
4 MMRs on file — 50126, 50123, 50104.1, 50051
§111.255
Batch Production Records
Issue per PROD-002 for each production batch.
§111.90
OOS investigation process
LAB-004 Phase 1 + Phase 2 procedure on file
§111.605
Record retention
DOC-001 on file
21 CFR 11
Electronic records & signatures
DOC-002 on file
Quotes & Project Inquiries
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Material Qualification — QA Testing
Where QA qualifies ingredients & packaging and tracks testing through to disposition. Identity, heavy metals, microbial and other tests per §111.75. Attach lab/vendor COAs to each record. Three logs below per the QA testing workflow.
Raw Material Testing
Packaging Components
Premix Testing
Finished Product Testing