Suplylot

Sector

GMP, excipients and traceability in pharmaceuticals

APIs, excipients and primary packaging: manage supplier qualification, CEP/DMF files and batch traceability for your quality and regulatory audits.

  • GMP supplier qualification
  • CEP, DMF and batch COA
  • Upstream API & excipient traceability
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Finished product sheet

API tablet lot FP-204

On the right: the finished-product sheet. On the image: each point is a component that feeds this completeness.

Hover a component on the product to read its sheet.

Pharmaceutical tablets in blister, finished product
Main API
Lactose monohydrate
Film coating
Ethyl alcohol
Gelatin capsule
Secure label

API tablet lot FP-204

7/7 materials mapped through tier 2

6/6 component coverage

Finished product sheet

API tablet lot FP-204

The QA lot is only released with REACH / SCIP on excipients, CLP, packaging GPSR, brand protection and GMP evidence at tablet level.

Compliance riskUnder watch

3 components under watch. The product sheet aggregates component readings.

SupplyUnder watch

2 components under watch. The product sheet aggregates component readings.

Supplier performanceUnder watch

2 components under watch. The product sheet aggregates component readings.

Product carbon impact

Below target

0.19kg CO₂e

PCF · per blister · cradle-to-gate

PCF for API, excipients and blister. GMP supplier data available for lot FP-204.

Product compliance frameworks

  • REACH / SCIPWithin limits

    Excipients and packaging without blocking SVHC. Ph. Eur. impurities below release thresholds.

  • CLPCompliant

    SDS for alcohol and process materials up to date. Classification consistent with lot FP-204.

  • GPSR / packagingDocumented

    Blister and label: packaging risk assessment and operators documented.

  • Brand protectionUnder control

    API and packaging channel authenticated. Supplier qualifications up to date.

  • MDROut of scope

    Tablet outside medical devices. Focus on GMP / CEP-DMF, REACH and packaging.

  • PPWRUnder watch

    Blister and carton under recyclability and packaging declaration watch.

Material cascade

From finished product to every upstream material: pharmaceuticals

Mapping example: every material is evaluated by the buyer on compliance, capacity, traceability and supply risk.

Finished product

API tablet batch FP-204

Batch, QA release validated

Main API

PharmaAPI

R1
SupplyUnder controlSupplyMain API · PharmaAPISupply : PharmaAPI : couverture matière, lead time et capacité lus sur la position supply. Critères : DMF, GMP.Supply
ComplianceUnder controlComplianceMain API · PharmaAPIBrand protection : Canal API authentifié. DMF / GMP up to date. REACH : Impuretés sous seuils de libération.Compliance
TraceabilityUnder controlTraceabilityMain API · PharmaAPITraçabilité : PharmaAPI : provenance et lots cartographiés pour Main API. Traçabilité rang 1.Traceability
Under control91/100

Lactose monohydrate

ExcipPharma

R1
SupplyUnder controlSupplyLactose monohydrate · ExcipPharmaSupply : ExcipPharma : couverture matière, lead time et capacité lus sur la position supply. Critères : CEP, Particle size.Supply
ComplianceWithin limitsComplianceLactose monohydrate · ExcipPharmaREACH / SCIP : Excipient CEP sans SVHC bloquante. CLP : FDS et granulométrie compliant.Compliance
TraceabilityUnder controlTraceabilityLactose monohydrate · ExcipPharmaTraçabilité : ExcipPharma : provenance et lots cartographiés pour Lactose monohydrate. Traçabilité rang 1.Traceability
Under control87/100

Film coating

CoatPharma

R1
SupplyUnder watchSupplyFilm coating · CoatPharmaSupply : CoatPharma : couverture matière, lead time et capacité lus sur la position supply. Critères : USP, Dissolution.Supply
ComplianceUnder watchComplianceFilm coating · CoatPharmaGPSR : Enrobage USP / dissolution documented. PPWR : Contribution emballage primaire under watch.Compliance
TraceabilityUnder watchTraceabilityFilm coating · CoatPharmaTraçabilité : CoatPharma : provenance et lots cartographiés pour Film coating. Traçabilité rang 1.Traceability
Under control80/100

Ethyl alcohol

AlcoGMP

R1
SupplyUnder controlSupplyEthyl alcohol · AlcoGMPSupply : AlcoGMP : couverture matière, lead time et capacité lus sur la position supply. Critères : Ph. Eur., Purity.Supply
ComplianceCompliantComplianceEthyl alcohol · AlcoGMPCLP : Ph. Eur. et FDS up to date.Compliance
TraceabilityUnder controlTraceabilityEthyl alcohol · AlcoGMPTraçabilité : AlcoGMP : provenance et lots cartographiés pour Ethyl alcohol. Traçabilité rang 1.Traceability
Under control85/100

Gelatin capsule

CapsuPro

R1
SupplyUnder watchSupplyGelatin capsule · CapsuProSupply : CapsuPro : couverture matière, lead time et capacité lus sur la position supply. Critères : Bovine origin, TSE/BSE.Supply
ComplianceUnder watchComplianceGelatin capsule · CapsuProGPSR : Origine bovine / TSE-BSE under watch. Brand protection : Qualification capsule up to date.Compliance
TraceabilityUnder watchTraceabilityGelatin capsule · CapsuProTraçabilité : CapsuPro : Bovine origin suivi sur Gelatin capsule. Lien lot / pays d'origine disponible.Traceability
Under watch78/100

Secure label

LabelPharma

R1
SupplyUnder controlSupplySecure label · LabelPharmaSupply : LabelPharma : couverture matière, lead time et capacité lus sur la position supply. Critères : Serialization, Qualification.Supply
ComplianceUnder watchComplianceSecure label · LabelPharmaGPSR : Serialization et opérateurs documented. PPWR : Étui / étiquette under watch déclaration emballage.Compliance
TraceabilityUnder controlTraceabilitySecure label · LabelPharmaTraçabilité : LabelPharma : provenance et lots cartographiés pour Secure label. Traçabilité rang 1.Traceability
Under control83/100

API precursor

SynthAPI

← Main API

R2
SupplyUnder watchSupplyAPI precursor · SynthAPISupply : SynthAPI : couverture matière, lead time et capacité lus sur la position supply. Critères : Upstream GMP, Audit.Supply
ComplianceUnder watchComplianceAPI precursor · SynthAPIBrand protection : GMP amont et mono-source under watch.Compliance
TraceabilityUnder watchTraceabilityAPI precursor · SynthAPITraçabilité : SynthAPI : provenance et lots cartographiés pour API precursor. Traçabilité rang 2.Traceability
Under watch72/100

Finished product

Starting point: the processed product and its material bill of materials.

Materials & components

Every critical reference linked to its supplier and its evidence.

Upstream links

Tier 1 and tier 2 mapped: origin, capacity, single-source risk.

Consolidated status

Compliance, risk and material coverage read at the product chain level.

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Manage your material purchasing in pharmaceuticals

Supplier qualification, incoming COA and upstream cascade: one platform to secure your production.

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