Pharmaceutical Industry Chain
Plant-Based New Drug
New Antibody Drug
Classification of Suppliers’Risks
Oneness Biotech established the “Supplier Management Procedure” as early as 2017. This operating procedure specifies the procedures for the assessment, evaluation, and approval of raw material and supplies suppliers to ensure that raw materials and supplies are purchased from qualified suppliers, and that the raw materials and supplies used in the drug production process meet their quality requirements. The risks of the suppliers for FESPIXON® cream are classified into the following levels according to Oneness Biotech’s “Supplier Management Procedure” and the attributes of the products supplied:
Examination and Evaluation of New Suppliers
In order to have active control of suppliers’ risks in relation to sustainability, Oneness Biotech examines all the suppliers’ risk states when they first register with us, the examination including a preliminary risk assessment based on a supplier’s business license, tax payment certificate, company profile, quality certificates, and certificate for environment, Health and Health(EHS). According to Oneness Biotech’s “Supplier Management Procedure”, the examination items of a new supplier are as follows:
Suppliers’ Code of Conduct
Oneness Biotech teams up with suppliers to create sustainable enterprises. The Supplier CSR Commitment Letter has been formulated with reference to the related international initiatives and requirements, including the UN Global Compact, the Universal Declaration of Human Rights, and the UN Framework and Guiding Principles on Business and Human. All the suppliers are required to sign the Letter, of which main contents include the following sustainability-related items:
- Environmental protection policies
- Prohibiting child labor
- Protect basic labor rights, including the right to work and the freedom of assembly
- Guaranteeing working hours and work conditions
- Complying with laws and regulations related to occupational safety
- Ethical governance
Management Measures for Existing Suppliers/ Qualified Suppliers
As of the end of 2021, Oneness Biotech had 20 collaborating suppliers for the new drug FESPIXON® cream. The levels of risk of those suppliers have been evaluated periodically and are as follows:
As for the geographical location of above mentioned suppliers’ manufactures, Taiwan is 50%, Asia is 30%, Americas 10% and European region is 10%.
Evaluation Items
Grading Results of Supplier Evaluation
Frequency of Evaluation
The following annual evaluation and review plan is made according to the “Supplier Management Procedure” and with reference to the grades of critical material suppliers and the annual evaluation results:
Note: As of the end of December 2021, the Company completed the evaluation of all its suppliers according to the evalutation and review plan.
On-Site Audits
The timing of conducting an on-site audit is as follows:
- When evaluating a new supplier candidate
- When conducting a regular audit on an existing supplier (according to the Supplier Audit Plan)
- When an existing supplier has a major defect in quality (e.g., when a quality-related customer complaint is attributable to the supplier as indicated by investigation results)
Survey and Evaluation of Sustainability-Related Risks
In order to control the suppliers’ sustainable risks, Oneness Biotech assess all the suppliers’ risk states when they apply to be our cooperated companies. The assessment including a preliminary risk assessment based on a supplier’s business license, tax payment certificate, company profile, quality certificates, and EHS certificates. In addition, the “Supplier Assessment Form” is issued on a regular basis in order for each supplier to fill out the form according to their cooperativeness, delivery dates, raw material/supplies quality, and quality system, and for the Company to know each supplier’s operational risks. A supplier will be disqualified if the total score of supplier assessment is lower than 70 or if the supplier has been found to have a major deficiency that may impair product quality.
In 2022, Oneness Biotech revised the “Operating Procedure for Supplier Management” and added the Supplier Self-Assessment Questionnaire (SAQ), which, in addition to the items in the existing “Supplier Assessment Form”, includes ESG assessment items as environmental protection, labor conditions, human rights, and corporate governance. The additional items and the existing items of cooperativeness, delivery dates, raw material/supplies quality, and quality system jointly constitute the supplier risk evaluation, which accounts for 5% of the total scores on the evaluation. The new Operating Procedure is slated to take effect in the second half of 2022, and the evaluation result will serve as an important reference for future procurement policies of Oneness Biotech. As to high-risk suppliers, Oneness Biotech will conduct factory audits in order to propose suggestions and help make improvements, the objective being to create a sustainable environment with the suppliers.
※The above content is taken from the ESG Report
