Quality Compliance and Management
ScinoPharm Taiwan adheres to the latest cGMP guidelines. The company has successfully passed many government agency inspections, including: Taiwan TFDA, US FDA, Australia TGA, Japan PMDA, Hungarian NIP, Korea KFDA, Mexico COFEPRIS and German Authority. To date, the facility has been successfully audited by more than 90 international pharmaceutical companies.
ScinoPharm's compliance policies include strict adherence to the established code of Current Good Manufacturing Practices (cGMP). Our guidance document on cGMP is the ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients and all employees involved in any aspects of production receive formal cGMP training when they first join ScinoPharm and then further training on a regularly scheduled basis.
The Quality Management function at ScinoPharm consists of the following departments:
The Compliance Department is responsible for ensuring the operation and internal procedures are in compliant with the cGMP standard. Periodical internal audits are scheduled and conducted by the department to verify the compliance status. Inspections by the regulatory authorities and customer GMP audits are hosted by the COMP department. CGMP training courses are provided to the employees to enhance their sense of the cGMP. The department is also responsible for preparation of the Annual Product Review.
Quality Assurance (QA)
The Quality Assurance department is involved in all matters relating to quality. It is the function of the Quality Assurance department to establish systems and procedures that are designed to build quality into our products so that the function of Quality Control is more of a final check that the product meets specification rather than rejecting failing product. These systems and procedures are all described in written company policies which spell out the overall philosophy of the company with respect to how it intends to operate in order to be in compliance with appropriate GMP guidelines, and in a comprehensive set of Standard Operating Procedures which describe in detail how each task is performed and responsibilities that are assigned.
Quality Control (QC)
The Quality Control department tests all samples, from incoming raw materials, starting materials, in-process samples and finished product, for compliance against pre-established specifications to ensure that quality is monitored throughout the process. The QC department is also responsible for monitoring the water systems and environmental control for particulate and microbial levels in the facility and equipment. In addition, the QC department manages the stability studies and performs the testing of stability samples in which batches of each product are set up in stability chambers according to the ICH storage conditions. The department is staffed by well-educated and well-trained analytical chemists. The laboratories, including a microbiology laboratory, are equipped with a wide range of fully automated and validated state-of-the-art instruments.