QUALITY AND COMPLIANCE

Documentation & Process Management

Thai An Medical builds a comprehensive documentation and process management system to standardize operations. Technical dossiers, forms, and standard operating procedures (SOPs) are managed under a strict version control mechanism to ensure consistency and traceability across the entire system.

Training & Standard Operating Procedures

Training and operational standardization are deployed to ensure personnel strictly adhere to established technical procedures. Regular training minimizes deviations during the production process and enhances the stability of the operational system.

Change Control

Any changes regarding raw materials, product specifications, or manufacturing processes are executed under a rigorous internal control procedure. This activity ensures product stability across batches and mitigates operational risks.

Continuous Improvement

Thai An Medical monitors operational data and quality feedback to evaluate the efficiency of the production system. This insights-driven data is utilized to implement continuous improvement activities, contributing to enhanced product stability and quality.

Input Control

Incoming raw materials and supplies are inspected according to internal standards before being released into production. Supplier information and raw material batch records are managed to support evaluation and traceability.

In-Process Control

At critical stages, in-process inspection and operational parameter monitoring are applied to minimize deviations and ensure batch uniformity. Inspection results are recorded according to standard procedures for control and investigation purposes when needed.

Finished Product Inspection

Finished goods undergo inspection before dispatch based on technical criteria tailored to each product group – including appearance, dimensions/specifications, adhesion strength, stability, and other relevant technical requirements.

Batch Traceability

The batch traceability system supports quality management and auditing during distribution – encompassing raw material batches utilized, stage-by-stage manufacturing data, finished product testing results, packaging/labeling specifications, and batch-wise distribution records.

Product Safety

For products in contact with skin, appropriate safety control requirements are implemented; the approach may reference biocompatibility evaluation requirements such as ISO 10993 where applicable.

For products in the rapid test kit category, performance indicators are only published in strict accordance with the corresponding validation/registration dossiers.

EO Sterilization

For sterile products, the process includes an EO (ethylene oxide) sterilization stage according to control procedures. Sterile packaging, sterilization conditions, and post-sterilization testing are strictly controlled to ensure quality requirements are met before dispatch.