We have built a stable, secure, and high-quality pharmaceutical production and multinational supply chain, including from upstream raw material suppliers, outsourced manufacturing or distribution partners to downstream customers and users. We also have established a comprehensive procedure of drug recall and traceability management mechanism to keep a complete record of the flow and use of drugs, and timely supply high-quality and safe drugs to patients to meet the needs of patients.
Constructing a Comprehensive Supply Chain System
We are committed to building a sound, stable, secure, and high-quality pharmaceutical production and multinational supply chain, and implementing a top-down interlocking operation process, including drug demand integration planning, raw material procurement and supply, production and manufacturing quality control, drug preservation and transnational delivery, and even drug users at the end. We must all do effective pharmacovigilance and recall mechanism to ensure the drug safety for patients in various countries.
Accountable Supplier Management
3 Key Points to Strengthen Supplier Sustainability Management
PharmaEssentia continuously conveys formal or informal sustainability proclamation to supplier partners in order to create positive long-term impact. Procurement and other relevant departments began to draft “Supplier Code of Conduct” to advocate and to urge for signature of acknowledgement. We carried out PEC ESG Report advocacy to 177 suppliers in 2021.
Strengthen Supply Chain Management and Resilience
To prevent the impacts of COVID-19 on the supply chain, PharmaEssentia continues to enhance supply chain management and our response capacity by maintaining a safe inventory volume and to establish alternative sources of raw materials. By obtaining a balance between cost consideration, long-term raw material preparations and through quick response, we can actively reduce the risk of input disruption from the inability to obtain timely and stable supply.
Management strategy of supplier/contractor
All suppliers that required to sign the quality agreement have signed the agreement. The ratio of local suppliers continued to increase to 95.3% in 2021, while the ratio of procurement from local suppliers has been increased to 79.4%. There were 77 new suppliers. 45 of them are local suppliers, accounting for 58.4% of all suppliers.
Annual assessment of suppliers/contractors
In 2021, on-site audit could not be conducted for certain foreign suppliers due to COVID-19. Alternatively, assessment was conducted via questionnaires and document review. On-site audit was completed for all other suppliers in line with the “Supplier Audit Procedures”. No high-risk supplier was identified.
Ensuring the Quality and Safety of Drugs
Management approach on product quality and safety management
For the value chain of PharmaEssentia, from R&D, clinical trials, commercial mass production to patients’ use after listing, we use standardized operating procedures, comprehensive quality management, and complete product traceability systems. The concept of " Patients Safety and Quality First " is deeply rooted in each staff's daily operation and life , so as to effectively control drug risk management and protect the safety of patients’ use of drugs.
Risk assessment management of quality safety
Quality risk management is implemented throughout the product’s life cycle. Our Taichung Plant has formulated the “Quality Risk Management Procedures” in line with ICH Q9. Protect patients’ health and effectively control and reduce the risk of patients’ drug use through practicing good manufacturing quality risk management.
GMP/GDP Quality Training at the Production Plant
Risk Assessment and Maintenance of Clinical Trial Quality
Product Quality Assessment and Continuous Improvement
Excellent Manufacturing and Production
The three main facilities of PharmaEssentia Taichung Plant: Polyethylene Glycol (PEG) production factory, Drug Substance (DS) manufacturing plant, and sterile agent filling plant. Our Taichung Plant is the first biopharmaceutical plant in Taiwan to pass the EU's EMA inspection and obtain Good Manufacturing Practice (GMP) certification. The sterile agent filling plant also obtained GMP and GDP certification from TFDA in April 2020, and passed MFDS GMP audit in January 2021 and U.S. FDA plant audit in September 2021.
Three Main Facilities of PharmaEssentia
Drug Substance Manufacturing Production Process
Aseptic Preparation Filling Process
Safe and Stable Transnational Logistics and Transportation
We have established transnational logistics and transportation operation procedures, inventory management, distribution procedures and tracking mechanism in compliance with PIC/S GDP requirements to strictly control that the transportation of each batch of goods can be delivered to the designated destination in a compliant, fast and safe manner, such as outsourcing filling plants, medical institutions or distributors, so as to maintain the drug needs and safety of patients.
Product shipment and distribution system
Quality control of shipment and transportation
Distribution & Sale at the U.S. Market
Effective Pharmacovigilance and Recall Mechanism
PharmaEssentia officially established the “Pharmacovigilance Mechanism” in 2021 to continuously conduct safety monitoring and risk control over the new drugs after product launch. We also commit to complying with international pharmacovigilance standards and the Pharmaceutical Affairs Act, Regulations for Drug Safety Monitoring, and Regulations for Reporting Serious Adverse Reactions of Medicaments. Take the initiative to collect global safety database of post-marketing drugs and provide regular Periodic Safety Update Report (PSUR) to the competent authorities of various countries.
Global Pharmacovigilance System and Reporting Process
Pharmacovigilance Risk Management Plan
We actively take the initiative to identify known risks, detect potential risks, and continue to track major deficiencies in the safety of marketed drugs, ensuring the safety of drug users and formulating comprehensive drug risk management. The results from the “Periodic Safety Update Report (PSUR) “in 2021 indicated that no new safety information that may affect the safety of BESREMi® has been found. We will continue to collect safety data of BESREMi® at countries where it is marketed, and such data will be used to update the PSUR and to evaluate the risk and benefits of BESREMi®.
Product Traceability Mechanism
PharmaEssentia has established a product traceability mechanism for the global supply chain, detail the material number, lot number and factory activity records of each batch of pharmaceutical products to ensure the basic principles of product batch number coding such as lot flow and traceability, as well as the operational procedures for product lot release.
Drug serialization has been completed in 2020 for the BESREMi® marketed in the U.S., in which Pyramid Laboratories Inc. will be responsible for the packaging and serialization of pharmaceutical products to comply with relevant regulations from the U.S. FDA's Drug Supply Chain Security Act (DSCSA).
Drug Recall Mechanism
The Chapter of Product quality and patient safety
We have built a stable, secure, and high-quality pharmaceutical production and multinational supply chain, including from upstream raw material suppliers, outsourced manufacturing or distribution partners to downstream customers and users to meet the needs of patients.