What is planned, and what is not yet true
Luang Pharma is establishing a pharmaceutical manufacturing facility in the Boten Economic Zone, Lao PDR. The company is not yet manufacturing, holds no manufacturing licence, and none of its portfolio lines are registered or available for supply.
Luang Pharma holds no GMP certificate and no manufacturing licence. It has not released a batch, validated a method or run a stability programme. The work below is scheduled inside the twelve-month programme and will be evidenced when complete.
Validation
Months seven to nine of the programme cover connection of utilities, validation of the HVAC and purification systems, and establishment of the GMP documentation baseline. The plan calls for a validation master plan, an SOP list, batch record templates and a training matrix to be in place before trial production.
Training
All Lao employees are to receive one to three months of systematic training before commissioning, covering GMP practice, equipment operation, production safety, position SOPs and record keeping.
Before any product is supplied
Each portfolio line requires Lao FDD registration, GMP batch records, a validated analytical method, a stability programme, QA release and approved trilingual labelling. Those requirements are stated on every product record in the portfolio, and none of them is satisfied yet.