Shuang Hor Lingzhi Factory – Certification & Accreditation

One practical way is to measure a QUALITY of a product by looking at the quality certification and accreditation received. Now, let’s look at the certification and accreditation ShuangHor factory has received. (Source 1, Source 2)

Yung Kien Factory received GMP certification GMP logo

Certificate No:990110001
Authorized by: Industrial Development Bureau of Ministry of Economic Affairs, Taiwan, R.O.C in 2002

Yung Kien Factory also became the first Taiwanese manufacturer to be audited for compliance to the GMP of Ministry of Health Malaysia, and obtained import permits for the following products:

1. Registration No. of Jia Hor Lingzhi : MAL19971540TR
2. Registration No. of Jia Hor Hi-Fibre : MAL19984183T
3. Registration No. of Yung Kien Ganoderma : MAL20020782T
4. Registration No. of Yung Kien Pollen : MAL20020783T
5. Registration No. of Jia Hor Gynostemma Herbal Tea : MAL04125507T

Want to know more on what you need to do to get GMP from Kementerian Kesihatan
Malaysia (KKM)? Here is the link.

What is GMP? (Source)

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as “cGMP”. The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination.

Yung Kien Factory received ISO-9001 International Quality Accreditation

ISO9001_2010

 

iso9002

Valid period:from 6 February 2013 until 5 February 2016
Certified by: Bureau Veritas
Accreditation by: United Kingdom Accreditation Service (UKAS)

Yung Kien Factory passed ISO-9001: 2000 international quality certification in early 2001 (certificate No. 79525; this edition contains ISO’s strictest review standards), testifying to the Shuang Hor Group’s pursuit of perfection and sustainable management.

Even though ISO standards is not mandatory, Yung Kien factory still pursue and successfully received this high standard, ISO 9001: 2008. Third-party certification bodies need to provide independent confirmation that organizations meet the requirements of ISO 9001. For that we have Bereau Veritas to certify and extra accreditation by United Kingdom Accreditation Service (UKAS) too 🙂


 

 

Related Link – The world’s largest Lingzhi Technology Park, the home to 5-star Lingzhi Greenhouse Farm and two difficult-to-earn accreditation award.


Process from raw material to finished product (Shuang Hor Ganoderma)

  1. Raw Material
  2. Primary Crushing and Weighing
  3. Dual-phase Extraction – According to research findings, in order to reap maximized potency, the valuable constituents of Lingzhi have to be extracted through separate phases – a techniques that not only requires specialized know-know but also advanced equipments. The Dual-phase Extraction & Concentration technique originally developed by Yung Kien Factory is by far the only method through which the effectively constituents of Lingzhi can be fully extracted.
  4. Low-temperature Vacuum Concentration – Upon full extraction of the effective constituents and for the purpose of preserving their intactness, Yung Kien Factory employs the unique Vacuum Freeze- drying System to produce liquid Lingzhi concentrate with consistent and umcompromised quality of the highest grade.
  5. Vacuum Freeze-drying
  6. Grinding & Inspection of Qualified Powder
  7. Automatic Capsule Filling
  8. Polishing
  9. Inspection of Qualified Capsules
  10. Automatic Counting & Bottle Filing
  11. Automatic Capping & Metal Detection
  12.  Package Box & Shrink Film
  13. Finished Product: Shuang How Ganoderma

Related Link – The first Lingzhi Technology Professional R&D Team in the world and the world’s largest Lingzhi Technology Park


 

Glossary (Source)

Certification is a comprehensive evaluation of a process, system, product, event, or skill typically measured against some existing norm or standard. Industry and/or trade associations will often create certification programs to test and evaluate the skills of those performing services within the interest area of that association. But testing laboratories may also certify that certain products meet pre-established standards, or governmental agencies may certify that a company is meeting existing regulations (such as emission limits).

Accreditation is the formal declaration by a neutral third party that the certification program is administered in a way that meets the relevant norms or standards of certification program (such as ISO/IEC 17024). Many nations have established specific bodies. In the United Kingdom, for example, an organization known as United Kingdom Accreditation Service (UKAS) has been established as the nation’s official accreditation body. Most European nations have similar organizations established to provide accreditation services within their borders.

There is no such “approved” accreditation body within the United States, however. As a result, over the years multiple accreditation bodies have become established to address the accreditation needs of specific industries or market segments. Some of these accreditation services are for profit entities, however the majority are not-for-profit bodies that provide accreditation services as part of their mission.