01
Process and packaging equipment
Formulation, filling, lyophilisation, inspection, labelling and packaging equipment.
Procurement
Suppliers to the Boten manufacturing project.
The Boten plant is being built and equipped. Luang Pharma is identifying suppliers of equipment, materials and services, and qualifies each one before it becomes part of the supply chain.
- Project stage
- Construction and fit-out · in progress
- Supplier route
- Company contact form
- Purchase commitment from an introduction
- None
Supplier introductions are reviewed against the project’s needs; an introduction is not a tender, a qualification or an order.
01 · Project stage
A plant under construction is a plant that is buying.
Equipment, utilities, controlled environments, materials and services have to be selected before they can be installed, qualified and validated. The order in which that happens is set out in the project roadmap. Suppliers who introduce themselves now can be considered as each need arises.
02 · Categories
Seven supply categories.
02
Cleanroom, HVAC and utilities
Controlled-environment construction, air handling, purified water, clean steam, compressed gases and monitoring.
03
APIs and excipients
Active substances and excipients of pharmaceutical grade, with their regulatory documentation.
04
Primary and secondary packaging materials
Vials, cartridges, ampoules, closures, labels, cartons and leaflets.
05
Laboratory instruments and reagents
Analytical instruments, reference standards, reagents and consumables for quality-control testing.
06
Qualification, validation and engineering services
Commissioning, qualification, validation, calibration and engineering support.
07
Logistics
International freight, customs handling and temperature-controlled transport to Boten.
03 · Supplier qualification
What a supplier should expect.
Requirements are applied in proportion to the risk of the item: an API is assessed more deeply than a logistics service.
- 01
Qualification questionnaire
Company particulars, quality certifications, manufacturing sites, and the regulatory status of the item supplied.
- 02
Quality agreement
Responsibilities for specifications, change notification, deviations, complaints and records, agreed in writing before supply.
- 03
Audit rights
The right to audit the supplier’s site and quality system, on site or by documentation, before approval and during supply.
- 04
Certificate of analysis
A certificate of analysis for every batch of material supplied, against an agreed specification.
- 05
Regulatory file for APIs
For an active substance: its Drug Master File or Certificate of Suitability (CEP) status, and access to the information a registration dossier needs.
04 · Conduct
Raising a concern about procurement conduct.
A concern about the conduct of a procurement contact, or a request that seems improper, can be raised through the route described in Ethics and reporting.
05 · Introduce your company
Use the company contact form.
Start the message with Supplier introduction and the category from the list above. Include your company name and country, the items or services you supply, the relevant certifications and, for APIs and excipients, the regulatory documentation available.
Do not send price lists, samples or confidential technical files with a first message. They are requested when a need is being assessed.
Professional enquiries
Introduce your company as a supplier.
Start the message with “Supplier introduction”, the category, your company name and country.