Product Quality and Safety

Management Approach：

Bora Pharmaceuticals adheres to international quality standards and regulations, establishing comprehensive quality control procedures and systems that encompass every stage of a drug’s lifecycle, including research and development, manufacturing, testing, and supply chain management. The company has implemented safety management plans and reports to ensure the quality and safety of its pharmaceutical products. By continuously enhancing standard operating procedures and compliance, Bora is committed to safeguarding medication safety for patients worldwide, driving continuous improvement, and striving for excellence.

Regulatory Compliance and Audits

A. Facility-Specific Regulatory Compliance and Audits

1. Facility-Specific Regulatory Compliance and Audits

Each facility of Bora Pharmaceuticals follows regulatory requirements based on its product types and target markets. All facilities are regularly audited by regulatory authorities and customers to ensure compliance. The following regulations apply：

• PIC/S GMP
• US FDA 21CFR （US FDA）
• EU GMP
• Health Canada
• PMDA（Japan）

2. Compliance with the Latest Regulations

• To maintain regulatory compliance, Bora Pharmaceuticals subscribes to the “Regulatory Intelligence Newsletter” to stay updated on the latest regulatory changes and FDA inspection findings.
• This information is distributed to each facility on a monthly basis, prompting necessary actions where needed.
• Additionally, quarterly sharing and discussion meetings are held to promote awareness and facilitate proactive responses to regulatory changes.

B. Self-Inspections

1. Audit Mechanism

• Bora conducts independent self-audits to evaluate the adequacy and compliance of quality system procedures, standards, and other requirements.
• Each quality system is audited at least once annually according to the audit plan.

2. Continuous Improvement

• The results of self-audits are utilized to ensure continuous improvement and compliance, enhancing the effectiveness of the quality management system.

Introduction to Standards Followed by Taiwan Facilities

Introduction to Standards Followed by Overseas Facilities

Quality Management System

A. Product quality management

Throughout the process from drug production to shipment, there are corresponding controls at different stages to ensure the good product quality, including:：

B. Quality System Monitoring

1. Quality Monitoring Mechanism

• The Quality Unit analyzes the effectiveness of the quality system on a monthly basis and reports to senior management.
• Senior management actively promotes a production environment that complies with regulatory requirements.

1. Quality Committee Operations

• The Quality Committee, organized by senior management, holds monthly meetings.
• It reviews, addresses, and improves quality issues arising in various facilities.

C. Quality Risk Management

1. Risk Assessment and Management

• Quality risk management is conducted in accordance with the ICH Q9 Quality Risk Management guidelines to assess product quality risks.
• Risk management tools are applied to identify, analyze, evaluate, control, communicate, and review potential risks related to processes and quality systems.

2. Timely Decision-Making and Regulatory Compliance

• Through risk management, Bora is able to make optimal decisions in real time, proactively ensuring compliance with regulatory requirements.

Management of Quality event

A. Investigation and CAPA
Bora has a comprehensive deviation investigation management system. The process is as follows:：

B. Critical Quality Event and product recall

1. When a quality event is identified, the quality unit will assess and determine whether it is a critical incident and notify the drug license holder within one business day. Customers will decide whether a product requires market warning, recall, withdrawal from the market, or stock recovery based on the information provided by Bora.
2. The drug license holder is responsible for coordinating product recalls, approving the recalls, and communicating with government authorities/agencies. If necessary, the quality assurance department will handle product traceability confirmation, relevant data collection, and investigations.
3. In addition, Bora executes material traceability check at least once annually.