DK PHARMA PHARMACEUTICAL FACTORY – BAC NINH BRANCH

DK Pharma has implemented and achieved certification for various quality standards, including:

1) GMP-WHO (World Health Organization’s Good Manufacturing Practices)

Since February 2010, DK Pharma has been certified as compliant with GMP-WHO. The implementation of GMP-WHO ensures strict control over infrastructure (factories, machinery), personnel, and production processes to eliminate the risk of contamination and cross-contamination, thereby guaranteeing the consistent quality of products. GMP provides a scientific, systematic, and comprehensive quality management approach, reducing incidents and risks in production and business operations.

DK Pharma’s production lines certified under GMP-WHO include:

• Eye, nose, and ear drops; Nasal sprays; Eye, nose, and ear suspensions; Nasal spray suspensions; Throat sprays.
• Oral solutions, suspensions; Syrups.
• Herbal medicines are traditional medicines in the form of hard capsules, tablets, solutions, suspensions, syrups, powders, granules, pills, liquid extracts, and herbal teas.

2) GLP, GSP, GDP Standards of the World Health Organization

GLP (Good Laboratory Practice):

Certified alongside GMP-WHO, the company has established a system of policies, objectives, testing procedures, resources, etc. to enhance the effectiveness of the laboratory system, ensuring objectivity, honesty, and accuracy in product quality assessment.

GSP (Good Storage Practice):

Certified alongside GMP-WHO, the company has established a system to control the storage and transportation of raw materials and products at all stages of production, storage, transportation, and distribution to ensure that finished products meet quality standards when reaching consumers.

GDP (Good Distribution Practice):

Certified alongside GMP-WHO, the company has established a system to control drug distribution to ensure the maintenance of drug quality during distribution.

3) ISO Standards

3.1. ISO 9001:2015 – International Standard for Quality Management

In September 2015, the company was certified to ISO 9001:2008 and upgraded to ISO 9001:2015 in September 2018. Since then, the company has consistently maintained the “ISO 9001:2015 International Standard for Quality Management” certified by JQA. This is an international standard for quality management. The application of this standard aims to ensure:

• • The stable supply of products and services that meet customer requirements;
  • Facilitating the enhancement of customer satisfaction;
  • Addressing risks and opportunities related to the company’s context and objectives;
  • The ability to demonstrate that the business has an effective quality management system that meets international standards.

3.2. ISO 13485:2016 (Quality management system for medical devices)

In December 2019, the company’s medical device manufacturing plant was certified to ISO 13485:2016 – Quality management system for medical devices. This is an international standard for quality management in the medical device field. The application of this standard aims to ensure:

• Providing medical devices with stable quality and safety for users.
• Improving product quality, effectively controlling risks, and minimizing the risk of errors.
• The ability to demonstrate that the business has an effective quality management system for medical device production and meets international standards.

3.3. ISO/IEC 17025:2017 (VILAS) – Internationally standardized laboratory

In February 2020, DK Pharma’s Quality Control Laboratory was certified to ISO/IEC 17025:2017 – An internationally standardized laboratory. This is an international standard for the competence of testing and calibration laboratories. The application of this standard aims to ensure:

• Ensuring that the company’s quality control laboratory has the technical competence and organizational management to operate effectively.
• Providing test results that are stable in terms of technical, reliable, and highly accurate.
• Ensuring that products manufactured by the company are tested to ensure high reliability before reaching consumers.

3.4 ISO 22000

In September 2022, DK Pharma’s extraction and production workshop was recognized as meeting ISO 22000 – Food safety management system for the closed-loop production of food and herbal extract:

The extraction system includes:

• A closed 5000L and 7000L extraction system with a closed-loop circulation system to increase the efficiency of concentrating herbal extracts, along with a modern vacuum distillation system to extract high concentrations without causing degradation or alteration of active ingredients, helping to optimize the concentration of active ingredients.
• A completely closed extraction system: The extract is extracted and transferred to a closed-loop circulation system and a vacuum distillation system completely closed by a system of pumps and stainless steel pipes, ensuring the control of microbiological safety for the product.
• Notably, the vacuum distillation pot is placed in a cleanroom system with a controlled cleanliness level to ensure a clean and closed process from input to output product.

The extraction system meets international quality standards in the field of food and herbal extract. The application of this standard aims to ensure:

• Providing food and herbal extract products with stable quality and safety for consumers.
• Improving product quality, effectively controlling risks, and minimizing the risk of errors.
• The ability to demonstrate that the business has an effective quality management system for food and herbal extract production and meets international standards.