Quality
Quality Control (QC) and Quality Assurance (QA) work together across the whole product life cycle — from incoming inspection and in-process control to release and post-market follow-up — under GMP, GDP and PIC/S.
Six dosage-form categories
Tablets
General drugs and Penicillins
Capsules
General drugs, Penicillins and Cephalosporins
Powders
Dry powders (general / Penicillins / Cephalosporins) and veterinary powders (general / Penicillins)
Liquids
Oral and other liquids
Ointments / creams
Creams, gels and ointments
Sterile products
Solutions (general), powders (general / Penicillins / Cephalosporins) and suspensions
Responsibilities of QC
- Prepare specifications and test methods for raw materials, finished products, packaging and printed materials
- Prepare in-process control specifications
- Inspect raw materials, packaging and printed materials
- Chemical and microbiological analysis during production
- Dissolution, particulate matter and physical tests
- Bacterial endotoxin and sterility tests
Responsibilities of QA
- Monitor purified water and water for injection (WFI) systems
- Process validation, cleaning validation and media fill
- Environmental monitoring for microbial contamination
- Stability testing and ASEAN-guideline stability dossiers for registration
- Returned goods, recall and customer complaint management
- Finished product release, risk management and control of non-conforming products
Organisation
QC department
The QC Manager oversees the heads of chemical and microbiological QC, supported by QC officers for raw-material testing, printed/packaging inspection, finished-product assay, instrument calibration and microbiology.
QA department
The QA Manager oversees the QA section head, QA officers and the returned-goods supervisor and staff.
Standards & certifications
GMP
Validated processes, contamination control and full batch traceability.
GDP
Proper storage, handling and transport to maintain product integrity.
PIC/S
Certificate of GMP/PICS Compliance of a Manufacturer, issued by the Food and Drug Administration (Thailand).
GMP / PIC/S certificates
Certificate of GMP/PICS Compliance of a Manufacturer, issued by the Food and Drug Administration (Thailand).
