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MMRs on File
4
50126 · 50123 · 50104.1 · 50051
Vendors Qualified
2 / 11
9 pending qualification
SOPs on File
32
DOC · FAC · LAB · MAT · PROD
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CFR 111 Compliance Status
§111.15 Facility SanitationFAC-001 ✓
§111.27 Calibration ProgramFAC-004 ✓
§111.70 Component Specs (MMR)4 MMRs ✓
§111.75 Identity Testing0/11 lots
§111.260 MMR on File4 products ✓
§111.255 BPRs Issued0 issued
§111.90 OOS ProcessLAB-004 ✓
§111.605 Record RetentionDOC-001 ✓
21 CFR Part 11 Elec. RecordsDOC-002 ✓
Vendor Qualification Program2/11 qualified
SOP Coverage
Document Control (DOC)2 SOPs
Facility & Equipment (FAC)7 SOPs
Laboratory (LAB)6 SOPs
Materials Management (MAT)8 SOPs
Production (PROD)9 SOPs
Blending / Encapsulation (BLD/ENC)Upload needed
Quick Access — SOPs
LAB-001Raw Material Testing
LAB-004OOS Investigation
MAT-001Receiving & Inspection
MAT-003Component Identity Testing
PROD-002BPR Issuance & Review
PROD-007In-Process Quality Checks
FAC-004Equipment Calibration
DOC-001Record Retention
Customer Raw Inventory
Customer Packaging
ASG Raw Inventory
ASG Packaging
Customer Raw Inventory
Raw materials designated for specific customers. Expand a customer to view their components.
👤 Dr. Pompa / ASI11 components▲
| ID | DESCRIPTION | LOT # | QTY ON HAND |
|---|---|---|---|
| R-CL009 | Sunflower Seed Oil - Organic | — | |
| R-CL003 | Hemp Seed Oil - Virgin | — | |
| R-SP014 | Yellow Beeswax | — | |
| R-SP048 | Sunflower Lecithin | — | |
| R-SP057 | Ahiflower Oil | — | |
| R-SP054 | Evening Primrose Oil 10% | — | |
| R-SP058 | Organic Seabuckthorn Oil/Seaberry Oil | — | |
| R-SP106 | Phosal 35 (Phosphatidycholine 35%) | — | |
| R-SP029 | Vitamin E (D-Alpha-Tocopherol) NO SUB | — | |
| R-SP059 | Organic HBD Cordyceps | — | |
| R-SP052 | Bovine Heart Powder | — |
👤 cbdMD3 components▲
| ID | DESCRIPTION | LOT # | QTY ON HAND |
|---|---|---|---|
| R-CL001 | MCT Oil | — | |
| R-AC005 | Broad Spectrum Distillate | — | |
| R-TR001 | D-Limonene Citrus | — |
👤 Hi-Health10 components▼
👤 Defender Shield7 components▼
👤 MDB9 components▼
👤 Medterra6 components▼
👤 Nautique7 components▼
👤 Ascential Nutrition5 components▼
👤 Centurion Health12 components▼
👤 Solva3 components▼
👤 Caper Labs2 components▼
👤 GreensWorld1 components▼
👤 TruBody Wellness1 components▼
Formulations (MMR)
REV 02 · APPROVED
Product Header
Product No.
50126
Product Name
Dr. Pompa Cellular Solutions
Serving
3 Softgels · 90ct bottle
Revision
02
Yield
25,000 Bottles
Blend Batches
13 × 193.00 kg
Company
ASI
Softgel Target Wt
1,000 mg (950–1,050)
Bill of Materials — Per Batch (193.00 kg) · Acceptable Range: 191.00–195.00 kg
1R-CL009Organic Sunflower Seed Oil536.00 mg103.077 kg
2R-SP014Yellow Beeswax72.00 mg13.846 kg
3R-SP048Sunflower Lecithin24.00 mg4.615 kg
4R-SP057Ahiflower Seed Oil105.00 mg20.192 kg
5R-SP054Evening Primrose Oil70.00 mg13.462 kg
6R-CL003Virgin Hemp Seed Oil50.00 mg9.615 kg
7R-SP058Sea Buckthorn Seed Oil35.00 mg6.731 kg
8R-SP106Phosal 35% (Soy Phosphatidylcholine)80.00 mg15.385 kg
9R-SP029D-Alpha Tocopherol (Vitamin E)14.00 mg2.692 kg
10R-SP059Organic HBD Cordyceps7.00 mg1.346 kg
11R-SP052Bovine Heart Powder7.00 mg1.346 kg
BATCH TOTAL
193.000 kg
Blending Procedure — Steps 1–17
1
Clean and sanitize Blending Room. Log in Equipment Cleaning and Use Record.
SOP: PROD-006
2
Inspect Blending Room.
SOP: PROD-006 (Line Clearance)
3
Select clean Medicine Tank. Record tank number. Verify water jacket full, valves closed, clamps tight.
4
Plug Medicine Tank into Heating Control Panel. Set heat to 78°C while prepping batch.
5
Locate weighed/allocated materials for the batch.
6
Add ITEM #1 — Organic Sunflower Seed Oil (103.077 kg) to Medicine Tank.
7
Wait until Item #1 reaches 78°C via portable temp probe before proceeding.
8
Set up High-Speed Mixer: raise hydraulically → position tank → lower mixer slowly → adjust speed gradually.
9
Add ITEM #2 (Beeswax 13.846 kg) + ITEM #3 (Lecithin 4.615 kg). Blend min. 15 min. Once wax melted, turn off heat. Record times.
10
Cool to 60°C. Add ITEMS #4 (Ahiflower 20.192), #5 (EPO 13.462), #6 (Hemp 9.615 kg). Blend min. 15 min.
11
Add ITEMS #7 (Sea Buckthorn 6.731), #8 (Phosal 15.385), #9 (Vit E 2.692 kg). Blend min. 15 min.
12
Add ITEM #10 (Cordyceps 1.346 kg) + ITEM #11 (Bovine Heart 1.346 kg). Blend min. 15 min.
13
Turn off High-Speed Mixer. Raise mixer hydraulically to remove Medicine Tank.
14
Transfer product into clean buckets. Tare each. Apply weigh tags. Acceptable yield: 191.00–195.00 kg.
15
Pull QA sample and deliver to QA.
SOP: PROD-007 (In-Process Checks) · MAT-002 (Sampling)
16
Clean and sanitize (Steps 6.20–6.31).
SOP: PROD-006
17
Complete Deviation Report if applicable. Submit all documentation to Document Control.
Approved Vendor Register
§111.75 Compliance Note
Only approved and qualified vendors may supply raw materials used in dietary supplement manufacturing. All vendors must complete the Vendor Qualification Questionnaire and have COAs reviewed before first purchase. 9 of 11 component suppliers still need qualification completed.Supplier A
B+
Evening Primrose Oil
R-SP054
APPROVED
Reviewed 2024
Supplier B
A
Phosal 35% (Soy PC)
R-SP106
APPROVED
Reviewed 2024
— Unassigned —
?
9 components need vendors
R-CL009
R-SP014
R-SP048
+6 more
QUALIFICATION NEEDED
Supplier A — Vendor Detail
Company Name
Supplier A
Components Supplied
R-SP054 Evening Primrose Oil
VQ Score
B+ (82/100)
Last Reviewed
2024-Q3
COA with Each Lot
✓ Yes
FDA Registered
✓ Yes
cGMP 21 CFR 111
✓ Yes
3rd Party Audited
✓ Yes
Heavy Metal Testing
✓ Yes
Micro Testing
✓ Yes
VQ SECTION SCORES
Regulatory Compliance & Certifications18/20
Quality Systems21/25
Testing & Analytical Controls17/25
Mfg & Documentation Controls16/20
Packaging & Shipping10/10
Gap: ISO 17025 Lab Accreditation
Lab not ISO 17025 accredited. Uses 3rd-party lab — name and accreditation not yet provided. Follow up required at next review.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
Date Established
Company Address
Warehouse Location
Company Size
Annual Sales
Contact Information
Website
Components Supplied to BYO
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
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0
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In Encapsulation
0
Batches on the machine
In Packaging
0
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Pending0
Sourcing0
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Encapsulation0
Sorting0
Packaging0
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Planning & Schedule
All Orders
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MON
TUE
WED
THU
FRI
SAT
Pre-Production Checklist
| REQUIREMENT | SOP | STATUS | ACTION |
|---|---|---|---|
| Vendor qualification complete | QA-006 | BLOCKING | |
| All RM lots identity tested | MAT-003 | 0/11 | |
| BPRs issued | PROD-002 | PENDING | |
| Equipment cleaning verified | FAC-003 | PENDING | |
| Scale calibration verified | FAC-004 | PENDING | |
| MMRs on file and approved | §111.260 | 4 MMRs ✓ |
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)
In-Process 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.
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