AV GROUP MEDICINE
The most powerful care to improve the efficiency and promote the development of your brain, with passion and energy.
End-to-end and trusted sustainability comes from integrating multiple sustainability information, gathering data at each level: raw materials and components, production processes, logistics and distribution, storage and warehouse, up to end-users. The result offers a holistic approach to sustainability.
RAW MATERIALS
| RAW MATERIALS | This Item | Lot |
|---|---|---|
| Production | 0,04 CO2e | 8.000 CO2e |
| Transportation | 0,02 CO2e | 4.000 CO2e |
PRODUCTION PROCESSES
| PRODUCTION PROCESSES | This item | Lot |
|---|---|---|
| Waste energy Generation | 0,01 CO2e | 2.000 CO2e |
| Energy Consumption | 0,06 CO2e | 12.000 CO2e |
| Water Consumption | 0,01 CO2e | 2.000 CO2e |
| Employee commuting | 0,01 CO2e | 2.000 CO2e |
STORAGE & WAREHOUSE
| STORAGE & WAREHOUSE | This item | Lot |
|---|---|---|
| Storage Energy Consumption | 0,01 CO2e | 2.000 CO2e |
LOGISTICS & DISTRIBUTION
| LOGISTICS & DISTRIBUTION | This item | Lot |
|---|---|---|
| Product Transportation | 0,02 CO2e | 4000 CO2e |
END-USER
| END-USER | This item | Lot |
|---|---|---|
| Products Distribution Impact | 0,01 CO2e | 2.000 CO2e |
| Products use impact | 0,001 CO2e | 200 CO2e |
| Products recycling | 0,01 CO2e | 2.000 CO2e |
ENERGETIC SOURCES FOR THIS UNIT
Traceability Regulatory compliance in pharmaceuticals ensures drug safety and effectiveness, and facilitates access to medically useful drugs. To meet regulatory requirements means adopting physical equipments for serialization and aggregation, and software serialization management at the enterprise level. Here is the full stack of requirements compliance.
Compliance
| Product SKU | Compliance |
|---|---|
| SKU 4225-776-3234 | USA, EU-EMVS, EU-NMVS, Bahrain |
| SKU 4225-776-3235 | BRAZIL, UAE, RU-Pharma, UZ-Pharma |
| SKU 4225-776-3236 | RU-Pharma, UZ-Pharma, KZ-Pharma, Saudi Arabia |
| SKU 4225-776-3237 | UAE, USA, EU-EMVS, EU-NMVS |
Compliance Tracking & Reporting
| Transaction Date | Ship to | Lot | Manufacturer | Qty | Ship from |
|---|---|---|---|---|---|
| 2022-05-12 | ACME Pharmacy (#014328) | A1370 | VINDO HEALTHCARE COMPANY | 100 | DEF DC NEWBURGH |
Quality is a holistic concept, where inspection, quality control and quality assurance interact.
Gathering data from multiple sources and at each level (line and factory) allows to reach measurable standards and optimize results and continuous improvements.
Preparation Activities – Quality assurance
Line Clearance
Activity start: 21/04/2023 – 16:32
Activity end: 21/04/2023 – 16:44
| Description | Result | User Signature | Evidence |
|---|---|---|---|
| Check position A | Clean | Fabio Bonetti | See Attachment 1 |
| Check position B | Clean | Fabio Bonetti | See Attachment 2 |
| Check position C | Clean | Fabio Bonetti | See Attachment 3 |
| Check Conveyor | Clean | Fabio Bonetti | See Attachment 4 |
Challenge Batch
Activity start: 21/04/2023 – 16:46
Activity end: 21/04/2023 – 16:58
| Description | Result | User Signature | Evidence |
|---|---|---|---|
| Wrong variable data rejection | 5/5 – Success | Fabio Bonetti | See batch report |
| Poor print quality rejection | 5/5 – Success | Fabio Bonetti | See batch report |
| Tamper evident rejection | 5/5 – Success | Fabio Bonetti | See batch report |
| Weight control rejection | 5/5 – Success | Fabio Bonetti | See batch report |
Inspection – Quality Control
| Description | Result | Evidence |
|---|---|---|
| Tamper Evident presence and position | OK | NA |
| Variable data consistency | OK | Check proof – OCV Control |
| ANSI grading | OK – Grade A | Check proof – Code Control |
| Code verifier | OK | Check proof – Code Control |
| Weight control | OK – 20,4 g | NA |
Check proof
Lot Deviation – Quality assurance
| Deviation Description | Date / Time | Has impact on this item |
|---|---|---|
| Humidity below threshold | 05/04/2023 – 10:25 AM | NO |
| Documental error | 05/04/2023 – 11:12 AM | YES |
| Staff not properly dressed in the production area | 05/04/2023 – 11:53 AM | NO |
System Qualification Status – Quality assurance
| Asset | Status | Document |
|---|---|---|
| Dispensing Scale | Qualified | DOC_000 |
| Filling Machine | Qualified | DOC_001 |
| Checkweigher | Qualified | DOC_002 |
| Print&Check | Qualified | DOC_003 |
| Case Packer | Qualified | DOC_004 |
| SCADA system | Qualified | DOC_005 |
Measuring efficiency in the manufacturing process allows productivity optimization, saving timing and reducing downtime.
LINE OEE
| Number of working days per week | 5 |
|---|---|
| Shift per Day | 2 |
| Hours per Shift | 8 |
| Total Production Hour | 80 |
| Planned Downtime (h/week) | 5 |
| Available Production Opening Time | 75 |
| Unplanned Downtime (h/week) | 6 |
| AVAILABILITY (%) | 92% |
| Line Standard Speed (theoretical max) (u/min) | 1.200 |
| Estimated actual speed (u/min) | 875 |
| PERFORMANCE (%) | 73% |
| Percentage of rejects | 3% |
| QUALITY (%) | 97% |
| OVERALL LINE OEE | 65% |
Supply chain transparency allows end-to-end knowledge about where and how products are produced, based on reliable data, and the sharing of information with internal and external players. DIAMIND provide solutions to achieve the end-to-end visibility of the supply chain and to meet compliance; the ability to share information with all the stakeholders contributes to designing an agile and collaborative supply chain, enabling the value chain.
Product Recipe Book
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| Material | Quantity /Batch | Contributions |
|---|---|---|
| INPUT Products | null | |
| Cetirizine HCl: 23089764623 | 10 mg | 10% |
| Hypromellose: 0002837986 | 90 mg | 88% |
| Lactose Monohydrate: 02903766525 | 1 mg | 1% |
| Titanium Dioxide: 09823857390 | 1 mg | 1% |
| OUTPUT Products | null | |
| AVMedicinae 24 :2409858637 | 102 mg | 100% |
Raw Material Tracking
| Trace Start | Trace 1 | Trace 2 |
|---|---|---|
| Cetirizine HCl: 23089764623 | AVMedicinae 24 :2409858637 | Value Add Pharmacies |
| AVMedicinae 12 :1209858637 | Terry’s Local Pharmacies |
Product Geolocatization
Production Site: Antares Vision, Via del Ferro, 16, 25039 Travagliato BS
Storage location: Antares Vision, Via Caduti del Lavoro, 13 – 43058 Sorbolo Mezzani (PR)
Product Real-time Monitoring
Logistic Company: AV Delivery Company
Shipment Storage condition: Between 10°C and 24°C
Temperature sensor: No alarm – Evidence
