1.Product Certification Scheme for Chinese Materia Medica Mr. KL Tsang, BBS, JP HKPC 5 September 2013

2. Hong Kong Productivity Council HKPC is a multi-disciplinary organization established by statute in 1967 to promote increased productivity and the use of more efficient methods throughout Hong Kongs business community. 1967 With about 300 professional consultants and multi-disciplinary expertise, backed by our advanced manufacturing support and over 30 testing facilities & technical centers 300 30 3. Hong Kong Productivity Council Over the past 40 years close working with various businesses , HKPC has developed and implemented a large number of certification and recognition schemes : 40 The Quality Tourism Scheme Quality Wedding Merchant Scheme The Quality Seawater Accreditation Scheme for the Health, Welfare and Food Bureau The accredited gemological certification and label scheme for diamond and jadeite jade The Quality Restaurant Environmental Management Accreditation Scheme GD & HK Joint recognition scheme The Hong Kong Awards for Industries The Hong Kong Awards for Environmental Excellence for the Environmental Campaign Committee The SME customer Service Excellence Award The Innovation-Knowledge Enterprise Award The Hong Kong Wireless Technology Excellence Awards; etc The Hong Kong Corporate Citizen Award, etc 4. Product Certification Scheme for Chinese Materia Medica CMM Certification CMM Certification Requirement Benefit of the Certification Scheme 5. What is the Product Certification Scheme for Chinese Materia Medica? ? HKPC is establishing a PCS for CMM initiated by CM Panel of HKCTC and funded by ITF and sponsored by CM trades CMM Certification is a voluntary programme in HK. The certification process includes management audit, documents & records audit, sampling, testing, evaluation , and surveillance in order to certifies the suppliers capability to provide product in compliance with the standard requirement. 6. What is the Standard which the Development of the PCS is Based on? ? The rules, procedures and requirements set in the PCS are based on related ISO standards, such as ISO Guide 67, ISO 17067, etc . Certification bodies and laboratories involved in the certification activities have to be accredited according to the ISO requirements. ISO Guide 67, ISO 17067 7. PCS Development and Subsequent Implementation PSC Development HKCTC / Chinese Medicine Panel/ITC/CM Trades Advice on PCS Support and Promote the PCS Funding the project , PCS, CMM Certification HKCAS Accredited Certification BodyHKPC ITF project applicant Develop the PCS Promote the PCS (PCS) Provide product certification services for CMM according to the PCS (PCS)Clients Project Advisory Committee Review & comment the PCS (PCS ) CMM Manufacturer, Trader, Importer etc User, Dealer, Buyer etc ()HOKLAS Accredited Testing Lab Provide accredited CMM testing () 8. Application No Document and Site AuditNoNoYes Yes Sampling and Testing Yes Review and Decision Attestation NoYes/ () SurveillanceNo//YesRenewalNo YesNo YesNoYes 9. What Chinese Materia Medica Can be Certified Chinese Materia Medica in Hong Kong Standard for Chinese Materia Medica ()CMM not in HKCMM Std but in the Pharmacopoeia of The People's Republic of China , may also be certified; however, the CMM has to be verified by authentication test, assay, and contaminants analysis; equivalent to those tests in HKCMM Std. 10. Certification Requirement 11. Certification Requirement Traceability of the CMM supply quality supply source and controlled delivery Applicants quality management quality system or procedure for handling the CMM , documents, personnel, and dealing with interested parties, etc - Product requirement sampling and testing in compliance with the related requirements in HK CMM Standards 12. Quality Management Applicants shell develop, operate, and maintain an effective quality management system or procedure that is capable of achieving the consistent fulfillment of the certification requirements, which shell address the following, but are not limited to : 1. CMM procurement & delivery 2. CMM quality inspection and acceptance conditions 3. Processing control 4. CMM Storage 5. Documentation system 6. Control of documents & record 7. Sale and after sale control 8. Recall 9. Complaint handling 10. Subcontracting control 11. Internal audit 12. Training; etc 13. Product requirement Comply with the related quality and requirements in HK CMM Standard 1. CMM Identification 2. Assay of CMM 3. Contaminants 14. CMM Identification According to HKCMM Standards, the methods for CMM identification including CMM description : outlook, shape, color, smell, hardness etc. Microscopic identification : such as cross section inspection Fingerprint chromatogram, the specific chemicals in the CMM showing on the chromatogram Comparing the collected results or/and figures with the Standards, helps to identify the CMM. 15. Assay of CMM In addition to the impurity, contaminant, water content etc, active ingredient or assay marker of a CMM may indicate the quality. For an example Ginsenoside Rb1, Ginsenoside Rg1, and Notoginsenoside R1 in Radix Notoginseng. By using a HPLC in a laboratory, it can determine the assay quantity in compliance with the standard limit. Rb1Rg1, R1 (HPLC) Assay of the Radix Notoginseng Sample 16. Contaminants Determination ContaminantLimit (not more than) mg/kgHeavy Metals Arsenic, Cadmium, Lead, Mercury2.0, 1.0, 5.0, 0.2Pesticide Residues Aldrin and Dieldrin0.05Chlordane0.05DDT1.0Endrin0.05Heptachlor0.05Hexachlorobenzene0.1Hexachlorocyclohexane isomers0.3Lindane0.6Quintozene1.0Mycotoxins Aflatoxin B1 & Aflatoxins5 &10 ug/kg 17. Benefit of the Certification Scheme 18. Why HK Needs a PCS for CMM? ? Chinese medicine has become more popular worldwide Supported by the National 12th Five-Year Plan to nurture the emerging industries , HK is privileged in view of its special position, technologies, experiences and credit to capture this opportunity through establishing itself as a Chinese medicine international trading center To develop the Chinese medicine trading, laboratory testing, and certification industries In line with the development of emerging industries, and also enhancing consumers confidence. 19. What is the Benefits of the PCS to CMM? Promoting quality product quality through upstream control Create business opportunities when products being certified Through third-party involvement Increase the confidence to the products quality Strengthen the quality management Effective product promotion Improve company image Reduce liability and recall of products 20. The Scheme Applicants CM trades with effective license in HK To ensure the CMM quality conformity, the applicant should establish and operate a CMM quality operational system or procedure for daily operations, CMM procurement & sales, CMM storage & test, documentation & records, etc 21. When is the PCS Ready? How to apply? ?? The CMM-PCS has been drafted and is under pilot testing. Once the PCS is promulgated, applicants may approach the qualified certification bodies for details and application. 22. Thank You! K L Tsang General Manager Hong Kong Productivity Council Environmental Management Division (Tel.: 2788-5628) kltsang@hkpc.org