Product Quality and Safety

Bora Pharmaceuticals adheres to international quality standards and market regulations to ensure the highest quality is maintained at every stage of the product lifecycle. Managing drug quality and safety is the company’s responsibility, which relies on cross-departmental collaboration and the participation, commitment, and execution of all employees.

Regulatory Compliance and Audits

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 CFR21 (US FDA)
EU GMP
Health Canada
PMDA (Japan)

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.

Self-Inspections

Bora’s self-inspection system operates independently to assess the adequacy and compliance of established procedures, specifications, and other requirements of Bora’s Quality System.
Each quality system undergoes an audit at least once a year, following the established audit plan, to ensure continuous improvement and compliance

Training Program

Bora has a training program in place to assure that all personnel have a thorough understanding of their jobs in order to perform their assigned responsibilities adequately, safely, and according to GxP requirements. The effectiveness of training is evaluated through Knowledge Transfer Assessment (KTA)/Quiz or Job Skill Qualification to ensure the employees are well trained/qualified for assigned GMP relevant tasks.

GxP refreshment training will be held at least twice annually for employees.
Attending external training programs organized by domestic and international institutions.

Quality Management System

Bora establishes and implements a quality system to ensure high quality in its manufacturing and commercialization activities. Drug products are produced in compliance with regional GxP standards and regulations, Pharmacopoeia standards, and established specifications to ensure product purity, identity, safety, potency, efficacy and quality.

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:

Quality System Monitoring
Quality unit monitors the effectiveness of quality system by generating monthly analysis and reports to senior management. Senior management actively drives compliance and fosters a compliant environment. Quality Council meeting is organized on monthly basis for senior management to review, solve and improve quality issues raised on site.

Quality Risk Management
Quality risk management (QRM) approach to evaluate risks to the quality of the product on the basis of the ICH Q9 Guideline “Quality Risk Management”. Bora applies risk management tool to proactively and systematically identify, analyze, evaluate, control, communicate and review risks and potential quality issues related to products, processes and systems regulated by health authorities, and to facilitate better and more informed decisions.

Management of Quality event

Investigation and CAPA

Bora has a comprehensive deviation investigation management system. The process is as follows:

Critical Quality Event and product recall

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.
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.
In addition, Bora executes material traceability check at least once annually.

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