Ensuring the safety, effectiveness and quality of drugs is the unanimous goal among all employees of PharmaEssentia. In all stages of the value chain, PharmaEssentia follows the relevant regulations of the competent authorities of different countries, the pharmaceutical industry, as well as around 4,000 internal standard operating procedures (SOPs) and various plans and reports. Starting from preclinical studies, we follow the Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) for drug research, then move into the clinical trials. We conducted in accordance with the GCP to protect the rights, safety, and well-being of subjects, this is our most important goal at this stage. In manufacturing phase, we follow the GMP; at the time of distribution and supply, we follow the requirements of the GMP and GDP as well. As for the safety monitoring of post-marketing drugs, we follow the Good Pharmavigilance Practice (hereinafter referred to as GVP). Considering the limitations of safety data in clinical trials and safety issues arising from the widely use of the marketed drug, PharmaEssentia has established a pharmacovigilance function at the headquarters to integrate safety information of Ropeginterferon alfa-2b (P1101). In addition, we set up a global pharmacovigilance & reporting system among strategic partners and subsidiaries to react immediately and to reduce harm. We are devoted to monitoring illegal medicine by recall procedure and traceability management. Furthermore, we ensure that patients receive the medicine with proper usage by medical health education and prevention procedures. We demand of ourselves to meet the toughest safety standards and minimize any harms or defects to make sure the product we provide is safe and effective. Trust is the foundation of strong business relationships, PharmaEssentia is a trustworthy enterprise and we are eager to become a top multinational pharmaceutical company with social influence.
We use standardized operating procedures, comprehensive quality management and traceability systems along the entire value chain of PharmaEssentia, from R&D, to clinical trials, to commercial mass production, to patients’ use, with the objective to ensure the safety, effectiveness and quality of the product.
Ensuring the safety, effectiveness and quality of drugs is the ultimate goal among all employees of PharmaEssentia. Effective quality risk management is an indispensable part of maintaining drug quality and safety. Quality risk management is a systematic process for the evaluation, control, communication, and review of quality risks. It must be implemented in the entire drug life cycle, including clinical trials, raw material manufacturing, procedures, operations and equipment, product distribution, and pharmacovigilance. Only through good risk management can the safety of patients be guaranteed, and the risks of patients using drugs can be effectively controlled and reduced.
For the risk management on the operations of the Taichung manufacturing plant, the risk assessment is conducted based on the Procedure for Quality Risk Management formulated in accordance with the ICH Q9 Quality Risk Management and is based on the three risk evaluation factors: “probability”, “severity” and “detectability” of the tools recommended by the ICH Q9. For instruments and equipment, PharmaEssentia has created the Procedure for Risk Assessment of Equipment in accordance with the United States Pharmacopeia, and classifies risks based on the “GMP impact ability” and the “system complexity” to reduce product quality damage operational risks. Moreover, PharmaEssentia has introduced risk management to control the production process, environmental control, material supply and other matters to minimize quality hazards.
In order to maintain the long-term stability of drug quality and safety, to be in line with GMP, and to maintain the effective quality management system, PharmaEssentia conducts regular internal audits and occasional external audits to review the effectiveness of the quality management system and GMP compliance. PharmaEssentia has created the Procedure for Product Quality Review and regularly performs product quality review to ensure that the existing manufacturing process and the materials used can produce products that consistently meet the expected quality. PharmaEssentia also holds Quality Management Review meetings on a quarterly basis, and reviews and makes improvements on matters regarding to quality, based on the conclusion of those meetings. Then PharmaEssentia takes CAPAs based on the seriousness of the matters to ensure the stability and consistency of product manufacturing processes and product quality and use this as a basis for process improvement and optimization.
The quality and safety management of PharmaEssentia are in compliance with the official GMP regulations. The Company adopts the highest standards for quality and safety in personnel assignment, plant facilities and equipment, documents (specifications, operating instructions, SOPs and records), production, quality control, contracted/entrusted inspections, complaints, and product recall. Once any phase is found to be non-compliant with GMP, the production and sales shall be suspended to ensure that patients are provided with effective, safe, and high-quality drugs.
Taking the Company’s product Ropeginterferon alfa-2b (P1101) as an example, in addition to the continual process optimization and improvements by the R&D department in Taipei, the production department of the Taichung plant also conducts an optimization test for upscaled process.
The Company has formulated the SOP for Product Shipment for the shipment of APIs and preparations. The scope of its application includes the operation of shipment from the Taichung plant of PharmaEssentia, or the packaging before transportation from the Taichung plant to the contracted manufacturing factories / storage factories. Responsible personnel include personnel in the supply chain, QA Department, and warehouse management. They strictly control each stage to ensure that each operating procedure is verified and validated to meet GDP requirements, so that the products can be delivered to the designated destinations in compliance, quickly and safely, for the patients’ medicine use safety.
In order to know patient safety matters arising by large scale patients after the drug is marketed, PharmaEssentia has contracted with CROs to establish the pharmacovigilance mechanisms and develop standard operating procedures to continuously monitor on the safety of post-marketing drugs, to fulfill the responsibilities for products and patients.
In accordance with the principle of risk management, PharmaEssentia actively identify known risks, detect potential risks, and continue to track major deficiencies in the safety of marketed drugs to ensure the safety of drug users. At this stage, PharmaEssentia focuses on the assessment of safety risk assessment of the drug after marketing. Safety risk management relevant SOPs of the CRO are adopted and PharmaEssentia request CRO to develop risk management plans. For Taiwan’s market, PharmaEssentia will draft different levels of risk management content such as medication instructions, notifications to healthcare professional, and special risk prevention measures based on the templates provided by the TFDA , and develop a Risk Management Plan based on the safety characteristics of different product. After the drugs are marketed, real-world usage data will be collected to evaluate whether patients have chronic side effects after long-term use of the drug, and these data will be the basis for the Drug Risk and Benefit Evaluation. We regularly review the effectiveness of the risk management plan to reduce the risk of drug use and strive to ensure the safety of medication users.
|2019 CSR Report|