An audit-ready framework for sterile injectable packaging supply.
LBS International operates as a GDP-controlled distribution partner. Manufacturing, sterilisation, depyrogenation and RTU processing are performed by qualified manufacturing partners under recognised pharmaceutical quality systems.
A controlled framework, governed end-to-end.
The LBS quality framework spans supplier qualification, document management, change control, complaint handling, batch genealogy and controlled distribution — coordinated to support customer audit and qualification activities.
Supplier Qualification
Manufacturing partners qualified against pharmaceutical primary packaging requirements with formal onboarding records.
Traceability Controls
Lot-level genealogy from manufacturing partner batch through to customer delivery, retained for the regulated lifecycle.
Document Management
Version-controlled technical and quality documents with revision indices, effective dates and controlled distribution.
Change Control
Formal evaluation, classification and notification of material, process and supply chain changes.
Complaint Handling
Structured intake, investigation and CAPA workflow coordinated with manufacturing partners and end customers.
Batch Genealogy
Forward and backward traceability linking finished components to upstream raw material and processing lots.
Controlled Storage & Distribution
Storage and transport handled under Good Distribution Practice principles with environmental monitoring as required.
Quality Agreements
Customer quality agreements established to define responsibilities, change notification and escalation routes.
Recognised pharmaceutical standards across the supply chain.
Components manufactured under ISO 15378 by qualified pharmaceutical primary packaging partners.
Quality management systems applied across upstream manufacturing and distribution operations.
Type I borosilicate glass evaluated against USP <660> for hydrolytic resistance and chemical durability.
Material classification and testing aligned to European Pharmacopoeia 3.2.1 for parenteral preparations.
Moulded and tubular vials produced in accordance with ISO 8362-1 / 8362-4 dimensional and material requirements.
Drug Master File coverage available through manufacturing partners to support customer regulatory filings.
Components washed, depyrogenated and terminally sterilised — supplied tub & nest for aseptic filling.
Good Distribution Practice principles applied across European logistics and storage operations.
"Components are manufactured in accordance with applicable ISO vial and stopper dimensional standards and are intended for evaluation and qualification on standard pharmaceutical filling and lyophilisation equipment platforms."
Customer qualification activities, equipment compatibility assessments and process validation remain the responsibility of the receiving pharmaceutical or biotech organisation.
Engineering-grade documentation, ready for qualification review.
Documentation is maintained, version-controlled and released to qualified pharmaceutical customers under a confidentiality agreement.
Technical Specification Support
Material, dimensional and processing specifications aligned to customer evaluation requirements.
Validation Documentation
Sterilisation, depyrogenation and packaging validation summaries available under confidentiality.
Certificate of Analysis
Lot-specific CoA records issued in accordance with applicable specification limits.
Change Notification Management
Pre-defined notification windows for material, process and supply changes with classification rationale.
Supplier Qualification Support
Qualification dossiers, audit responses and questionnaire support coordinated with manufacturing partners.
Traceability Management
Lot-level traceability records retained in accordance with regulated lifecycle requirements.
Products are supplied for customer-specific technical evaluation, qualification and validation activities. Final suitability for commercial use remains subject to customer qualification and GMP validation requirements.