Controlled document SOP-001
Digital Standard Operating Procedure: OAA DUO
SOP-001 defines the approved manufacturing procedure for OAA DUO. It is the authoritative document for preparation, quality control, packaging, release and traceability. It does not contain scientific rationale (SDR) or formulation ownership (PF).
Record identification
- Document ID
- SOP-001
- Document type
- SOP
- Status
- Content pending
- Source
- Standardisation & Production of SIRIAM Products
Declared structure — entries pending
The structure below is defined by the source document. No entries are generated by the platform; they are released from the quality system.
Source document · Standardisation & Production of SIRIAM Products
Document Header
| Field | Value |
|---|---|
| id | SOP-001 |
| title | OAA DUO Manufacturing Procedure |
| linked_product | SIR-OAA-01 |
| linked_pf | PF-001 |
| linked_sdr | SDR-001 |
| version | 1.0 |
| status | Approved |
| language | EN |
| owner | SIRIAM LAB |
Scope
| Field | Value |
|---|---|
| applies_to | OAA DUO Phase 1, OAA DUO Phase 2 |
| dosage_form | Topical Cream |
| batch_size | 100 g |
| packaging | 15 mL Airless |
Responsibilities
| Field | Value |
|---|---|
| formulation | PF-001 |
| manufacturing | SOP-001 |
| quality_release | RM-006 |
| stability | RM-009 |
| inventory | RM-004 |
| raw_materials | RM-003 |
Required Materials
Lovable should generate a dynamic checklist.
No ingredient names are duplicated. Everything is linked.
| Field | Value |
|---|---|
| source | PF-001 |
| equipment | RM-007 |
Equipment
Render dynamically from RM-007. No equipment is manually entered into SOP.
| Equipment | Status | Calibration | Last Check |
|---|
Manufacturing Workflow
Lovable renders this as a vertical timeline.
The D&R document supports this preparation sequence, including controlled processing, QC, filling and stabilization.
- 01Preparation (Required)
- 02Water Phase
- 03Oil Phase
- 04Emulsification
- 05Controlled Cooling
- 06Addition of Heat-Sensitive Ingredients
- 07Homogenisation
- 08Quality Control
- 09Airless Filling
- 10Stabilisation (24 hours)
- 11Final Release
Quality Control
Each checkpoint becomes individually traceable.
| Checkpoint | Requirement |
|---|---|
| raw_material_identity | required |
| weight_control | required |
| appearance | required |
| homogeneity | required |
| viscosity | optional |
| packaging | required |
| labelling | required |
| documentation | required |
Release Criteria
| Field | Value |
|---|---|
| qc_complete | true |
| batch_signed | true |
| documentation_complete | true |
| packaging_verified | true |
| authorised_release | required |
Packaging
| Field | Value |
|---|---|
| primary | 15 mL Airless |
| secondary | Product Box (optional) |
| label | QR Enabled |
Traceability
| Field | Value |
|---|---|
| batch_number | dynamic |
| production_date | dynamic |
| expiry_date | dynamic |
| operator | dynamic |
| reviewer | dynamic |
Deviations
Every manufacturing deviation becomes an object.
Linked automatically to RM-008.
- deviation_id
- batch
- description
- corrective_action
- approval
Change Control
No changes are stored directly in SOP.
| Field | Value |
|---|---|
| linked_document | RM-008 |
Related Documents
relationships:
- SDR: SDR-001
- PF: PF-001
- RM: RM-003, RM-004, RM-005, RM-006, RM-007, RM-008, RM-009
Professional Mode
Lovable should display:
- Manufacturing Timeline
- Dynamic Equipment Checklist
- Dynamic Material Checklist
- QC Checklist
- Batch Release
- Deviation Log
- Traceability Panel
- Linked RM Records
Patient View
Patients do not access SOP. Instead show only:
Quality Assurance — Every batch of OAA DUO is prepared according to the approved SIRIAM manufacturing procedure and quality control system.
Lovable Components
Create reusable components:
- Manufacturing Timeline
- Equipment Checklist
- Material Checklist
- QC Checklist
- Batch Release Panel
- Traceability Card
- Deviation Register
- Packaging Card
- Release Badge
Related documents
Platform modules