Quality
Quality, explained in plain words
Medicine quality is full of acronyms. Here is what they mean, why they matter to the person taking the tablet, and where we stand on each one today.
The words you will see
Six terms worth knowing
GMP: Good Manufacturing Practice
The rules a medicine factory must follow: clean rooms, trained people, written procedures and records for every batch. In Thailand, the Thai FDA inspects factories against these rules.
PIC/S
An international network of medicine inspectors, which the Thai FDA has belonged to since 2016. PIC/S does not certify companies. It sets the GMP standard (called PE009) that its member inspectors use.
ICH Q7
International guidance on how to make the active ingredient, the part of a medicine that does the work. It is guidance to follow, not a certificate.
Pharmacopoeia
The official reference book (for example the USP) that defines what a medicine must contain and how to test it.
DMF: Drug Master File
A confidential file an ingredient maker lodges with regulators, describing exactly how the ingredient is made. We plan to buy ingredients from makers who already have one.
Bioequivalence
A study showing that a generic tablet releases its medicine into the body the same way as the original. Required for many prescription generics.
Where we stand
Designed for the standards; certificates still ahead
Our factory is being designed to meet GMP to the PIC/S standard, and, for future plant-derived ingredients, ICH Q7. We do not hold any GMP certificate yet. We cannot until the factory is built and inspected.
Design
Factory designed to GMP (PIC/S PE009)
Room layout, air handling, water and equipment chosen with inspection in mind.
Build
Qualification
Every machine and room is tested and documented before use.
Inspection
Thai FDA GMP certificate (target)
Required before any medicine can be supplied.
Registration
Each medicine registered with the Thai FDA
Using the common ASEAN dossier format, with bioequivalence studies where required.
Why established medicines help
Standing on proven ground
Because every medicine we plan to make already has a pharmacopoeia standard, and its ingredient already has DMFs held by experienced makers, the path to approval is well trodden. Our job is to do well what is already known, not to invent something new.