Quality Compliance and Management

ScinoPharm Taiwan adheres to the latest CGMP guidelines and has passed numerous government agency inspections, including Taiwan TFDA, EU EMA and EDQM, US FDA, Australia TGA, Hungary NIP, Japan PMDA, Korea KFDA, Mexico COFEPRIS, and German authority’s approval. We continue to improve the quality of our products and our quality management system to meet the expectations and requirements of different government authorities and customers.

The Quality Management function at ScinoPharm consists of the following departments:

 

Compliance (COMP)

Through regular internal audits, the COMP Department ensures that operations and internal procedures are compliant with the CGMP standards. The COMP Department provides needed support during regulatory authority reviews and customer audits. CGMP training sessions are given by the COMP Department to employees to reinforce the awareness of CGMP compliance.

 

Quality Assurance (QA)

The Quality Assurance Department is responsible for establishing systems and procedures that are designed to ensure product quality. These systems and procedures are written into our company policy, which spells out our company philosophy and describes how ScinoPharm intends to operate to comply with CGMP guidelines and Standard Operating Procedures, in turn ensuring that all required tasks are performed and that all responsibilities are assigned.

 

Quality Control (QC)

The Quality Control Department is staffed by well-educated and veteran chemistry experts. All our laboratories, including a microbiology laboratory, are equipped with fully automated, high-performance instruments that can be broadly used. The QC Department tests all samples such as incoming raw materials, starting materials, in-process samples, and finished products for compliance against pre-established specifications to ensure that all products are monitored during the process and that their qualities are guaranteed. The department monitors the water system and the production environment to check particulate and microbial levels in the facility and equipment. During stability testing, the department ensures that batches are correctly located in chambers that comply with the ICH storage condition. In addition, the department is responsible for managing and coordinating stability testing programs and arranging periodic annual product reviews.