Operations Dashboard
Production Pipeline
Pending
0
Sourcing
0
Blending
0
Encapsulation
0
Sorting
0
Packaging
0
Completed
0
Open Orders
0
Active production orders
In Blending
0
Batches currently blending
In Encapsulation
0
Batches on the machine
In Packaging
0
Batches being bottled
🗓 Today's Scheduled Runs
Nothing scheduled for today.
Active Production Orders
No production orders yet.
Click + New Order to get started.
Click + New Order to get started.
Lots Received — Recent
No lots received yet.
⚠ Batch Alerts & Action Items
No alerts — all batches on track
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)
Loading…
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
This questionnaire is sent to prospective vendors before approval. Completed responses are scored and reviewed by QA. All vendors supplying raw materials must be approved prior to first purchase (§111.75 / cGMP Supplier Qualification requirements).
Vendor 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
Regulatory Compliance & Certifications20 pts
Certifications
Is the facility registered with the FDA? If yes, provide registration number.
YesNoN/A
Is the facility cGMP certified under 21 CFR 111 (Dietary Supplements)?
YesNoN/A
Is the facility cGMP certified under 21 CFR 117 (Conventional Foods)?
YesNoN/A
Does the facility undergo third-party audits?
YesNoN/A
Does the facility hold ISO, NSF, USP, or other quality certifications? If yes, specify.
YesNoN/A
Is the facility GFSI Certified?
YesNoN/A
Are any products certified Organic, Kosher, or Halal? If yes, specify.
YesNoN/A
Has the company experienced product recalls, FDA 483 observations, or warning letters in the last 5 years?
YesNoN/A
Is there a documented process for customer complaint handling and adverse event reporting?
YesNoN/A
* If applicable, provide certificates when returning form.
Quality Systems25 pts
Are written SOPs maintained for all production, packaging, and testing processes?
YesNoN/A
Does the facility have an allergen management plan?
YesNoN/A
Does the facility have a Food Safety or HACCP Plan?
YesNoN/A
Does the facility have an Environmental Monitoring Program?
YesNoN/A
Does the facility have a Supplier Qualification Program of their own?
YesNoN/A
Does the facility have a Master Sanitation Plan?
YesNoN/A
Does the facility have a documented Quality Management System (QMS)?
YesNoN/A
How are deviations, OOS results, and CAPAs handled?
Testing & Analytical Controls25 pts
Do you provide a Certificate of Analysis (COA) with each lot?
YesNoN/A
Do you test raw materials for identity, purity, strength, and composition?
YesNoN/A
Do you test raw materials for heavy metals (lead, cadmium, arsenic, mercury)?
YesNoN/A
Do you test raw materials for microbial contamination?
YesNoN/A
Do you test raw materials for pesticides, mycotoxins, and residual solvents?
YesNoN/A
Are your laboratories ISO 17025 accredited?
YesNoN/A
Are tests performed in-house or by a third-party lab? If third-party, provide lab name(s) and accreditation.
Manufacturing & Documentation Controls20 pts
Describe your raw material receiving, inspection, and approval process.
How do you ensure materials are properly labeled and segregated during storage?
What environmental controls are maintained in storage areas (temp, humidity, light)?
How do you ensure lot-to-lot traceability from supplier through finished material?
Packaging & Shipping10 pts
Is packaging tamper-evident and compliant with applicable food-grade or dietary supplement standards?
YesNoN/A
Describe how materials are shipped to maintain quality (temp control, light protection, sealing, etc.).
What is your standard lead time and minimum order quantity (MOQ)?
Is there a documented process for customer complaint handling and adverse event reporting?
YesNoN/A
Production Orders
Active Orders
0
Across all products
In Blending
0
Batches currently blending
In Encapsulation
0
Batches on the machine
In Packaging
0
Batches being bottled
Pending0
Sourcing0
Blending0
Lab Test0
Encapsulation0
Sorting0
Packaging0
Completed0
✅ Completed / Shipped Orders 0
▸ Show
Planning & Schedule
All Activities
Gelatin
Blending
Blending 2
Encapsulation
Sorting
Packaging
SUN
MON
TUE
WED
THU
FRI
SAT
Lot Traceability
Trace Search
⬆ BACKWARD — VENDOR → RM → BLEND
Qualified Vendor (VQ on file)
Received & Identity Tested
Allocated to Blend Batches
Blended → Medicine Tank
⬇ FORWARD — BLEND → SOFTGEL → BOTTLE
Encapsulated → Softgels
Dried, Sorted → Bulk Bags
Release Tested (LAB-002)
Bottled & Labeled
Reserve Samples (§111.553)
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.
Document Control
DOC-001
Record Retention, Retrieval & Archival
DOC-002
Electronic Records & Signatures
Facility & Equipment
FAC-001
Facility Design, Maintenance & Sanitation
FAC-002
Pest Control Program
FAC-003
Equipment & Utensil Cleaning / Sanitization
FAC-004
Equipment Calibration Program
FAC-005
Preventive Maintenance Program
FAC-006
Environmental Monitoring (Temp / Humidity / Pest)
FAC-007
Utilities Qualification (Water, Air, HVAC)
Laboratory
LAB-001
Raw Material Testing (Identity, Microbial, Heavy Metals)
LAB-002
Finished Product Testing & Specifications
LAB-003
Stability Testing Program
LAB-004
Out-of-Specification (OOS) Investigation
LAB-005
Reference Standards & Reagent Management
LAB-006
Laboratory Equipment Qualification
Materials Management
MAT-001
Receiving & Incoming Inspection
MAT-002
Component Sampling Plan
MAT-003
Component Identity Testing
MAT-004
Material Status & Quarantine Labeling
MAT-005
Warehouse Storage & Inventory Control
MAT-006
FIFO / Expiration Date Management
MAT-007
Reserve Sample Retention
MAT-008
Finished Goods Shipping & Distribution
Production
PROD-001
MMR Development & Approval
PROD-002
Batch Production Record Issuance & Review
PROD-003
Softgel Encapsulation Operating Procedure
PROD-004
Softgel Drying, Tumbling & Sizing
PROD-005
Coating & Imprinting Procedure
PROD-006
Packaging Line Setup & Line Clearance
PROD-007
In-Process Quality Checks
PROD-008
Reprocessing & Rework
PROD-009
Yield Reconciliation & Material Balance
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 Key Procedure Requirements
—
6.0 Records Generated
—
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
Loading…
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