Lectures on Pharmacy Legislation (Lec 02)

Lecture 2 on Pharmacy Legislation 2010 was held on 23 April 2010.
The content included "Control of Antibiotics”, “Wholesale & Retail Sale of Poisons” and “Undesirable Medical Advertisements”.


Control of antibiotics in Hong Kong is governed by Antibiotics Ordinance (AO), Cap.137. The ordinance stated:
1. Substances to which the AO, Cap 137 applies
2. Control of Antibiotic Substances (Sale & Supply; Possession)
3. Permits to Deal in and to Possess Antibiotic
4. Maintenance of Records
5. Offences & Penalties ($5000; $30000 & to imprisonment for 12 months)

The following Substances were controlled under Cap.137:
- Septrin (P1S1S3), Nitrofurantoin (non-poison), Trimethoprim (P1S1S3), Metronidazole (P1), Nalidixic acid (P1S1S3) and Synalar N cream (P1S1S3, A), where Poison code – (P1S1S3) and Antibiotic (A).

For treatment, registered medical practitioner, registered dentist, registered veterinary surgeon, registered pharmacist or Authorized Seller of Poisons (ASP) under the authority of a prescription, signed & dated by a registered medical practitioner can sell or supply antibiotics.

There are only two permits to deal in and to possess Antibiotic Substances.
i) The Director of Health or any person authorized by him may issue a written permit to deal in antibiotic substances.
ii) The Director of Agriculture, Fisheries and Conservation may issue to any person a written permit to possess for the purposes of veterinary treatment.

Records shall be maintained and included:
- Name & address of person from whom received or to whom supplied (permit number if applicable)
- Quantity received or supplied
- Date received or supplied

Then Pharmacy and Poisons Ordinance (Cap. 138) was briefed. The poisons classification chart was shown.

Where A – Medicinal and B – Non-medicinal (e.g. cyanides); Listed Seller of Poisons (LSP) and Authorized Seller of Poisons (ASP)

LSP sale of part II Poisons are:
- Manufacturer’s original container
- No dispensing of prescription

ASP sale of Part I Poisons are:
- By a registered pharmacist; or
- In his/her presence and under his/her supervision

Under the 1971 Convention of Psychotropic Substances, the following items were requested.
- Maintain records showing the receipt, sale or supply of stock in hand in a specified format
- Supported in every case by invoice, order note or other voucher
(Full list in www.psdh.gov.hk → Application Guideline → Pharmaceutical Wholesale/Retail Licenses → Wholesale Poisons License)


The summary of retails sale of different poison is shown in the following table.

Holders of Wholesale Poisons Licence (WPL) and Licence for Manufacturer (ML) cannot sell poisons by retail, to members of public.

WPL or Wholesale dealer in medicines not containing poisons shall set up and maintain a recall system that will enable rapid and complete recall of any lot or batch or a pharmaceutical substance / product from sale to the public in the event of the pharmaceutical substance or product being found to be dangerous or injurious to health. (r.28(8))

Undesirable Medical Advertisement Ordinance (UMAO) (Cap. 231) was introduced. The intention of the ordinance aims to protect the public from being induced by such advertisements to seek improper treatment from unqualified persons or to resort to wrongful application of self-medication, with the result that there is delay in seeking proper treatment, making the disease much more difficult to cure.

Its amendment enacted on 29 June 2005 and Gazetted on 8 July 2005 (www.gld.gov.hk/egazette). It applies to “orally consumed product” included the following forms:
- pill, capsule, tablet, granule, powder, semi-solid, liquid, or a form similar to any of the forms mentioned above; and does not include a product which is customarily consumed only as food or drink or to satisfy a desire for taste, texture or flavour.


For more information:
Guideline on the labeling for registration of pharmaceutical products at www.psdh.gov.hk
Report on the review committee on regulation of pharmaceutical products in Hong Kong at http://www.fhb.gov.hk/
Guidelines on the UMAO (Cap. 231) at http://www.fhb.gov.hk/
Guidelines on the UMA (Amendment) Ordinance 2005 regarding “Orally Consumed Products” and Schedule 4 at http://www.fhb.gov.hk/

Lectures on Pharmacy Legislation (Lec 01)

Five Lectures on Pharmacy Legislation of Hong Kong were organized by the Department of Health and the Pharmaceutical Society of Hong Kong started on 16 April 2010.

Lecture 1 (16 April 2010):
Classification of Poisons
Labelling of Poisons and Pharmaceutical Products


The summary of Lecture 1 were shown as follows.
Laws concerned the following ordinances.
- Pharmacy and Poisons Ordinance (Cap. 138) – PPO
- Antibiotics Ordinance (Cap. 137) – AO
- Dangerous Drugs Ordinance (Cap. 134) – DDO
- Undesirable Medical Advertisements Ordinance (Cap. 231) – UMAO
- Chinese Medicine Ordinance (Cap. 549) – CMO
- Import and Export Ordinance (Cap. 60) – IEO
- Control of Chemicals Ordinance (Cap. 145) – CCO
- Public Health and Municipal Services Ordinance (Cap. 132) – PHMSO

The chart showed the classification of Drugs

The summary of classification in graph presentation is shown.

Then labeling of poisons and pharmaceutical products in Cap. 138 were introduced.

General labeling requirements for registration of pharmaceutical products included the following items.
1. Name of the product
2. Name and quantity of each active ingredient
3. Name and address of the manufacturer
4. Hong Kong registration number of the product
5. Batch Number
6. Expiry date
7. Specific storage conditions, if any

For sterile products, additional labeling requirement were need.
1. Name of preservative, if any
2. batch number and expiry date


For more information:
www.legislation.gov.hk
http://www.pshk.hk/

Symposium on Development of Product Testing and Certification in Hong Kong

I joined the Symposium on Development of Product Testing and Certification in Hong Kong which was organized by Hong Kong Institute of Vocational Education (IVE) and co-organized by HKQAA on 16 April 2010 (Friday). A summary was given below.

In the beginning, Mr. Leung Kwan Yeung (Chairman – Vocational Training Council (VTC)) gave an opening address. He said the VTC would provide more short term training courses and workshops for testing and certification industries based on the report of Hong Kong Council for Testing and Certification (HKCTC).


The first keynote speaker was Ir. Raymond Wong (Consumer Testing Services Director, SGS Hong Kong Ltd.) and his topic was “New Outlook, New Opportunities Insider’s Look into Testing & Certification Industry”.

Ir. Raymond Wong speech included four topics. They are:
New era – Testing & Certification Industry (T&C) as one of the 6 economic areas with clear advantage;
New factors – Success story of a global brand;
New evolution – From last 50 years to next 50 years; and
New trend – Sustainability defines our future.

He said that SGS would cooperate with VTC, and they focused in Traditional Chinese Medicine (TCM) and provided GMP training.

He explained the success of SGS based on TRUST. It included “NETWORK” , “EXPERIENCE”, “RESOURCES”, “EXPERTISE” and “COMMITMENT”.

Then SGS service values in 3Ps perspective were introduced. They are “Profit”, “People”, and “Planet”. In “People”, SGS had “Management Development Program” in which 30 staffs were selected for training to be middle management level in mainland universities per year, so as to develop a talent pool.

The second Keynote speaker was Mr. Harry Yeung (Chief Operating Officer, Hong Kong Standards and Testing Centre) and his speech entitled “Hong Kong Product Certification Program Development”.

Mr. Harry Yeung said Hong Kong lack of product certification scheme compared with other developed countries’ schemes such as UL, VDE, GS, etc. However several existing regulations were effective in Hong Kong included toys safety (1993), consumer product safety (1995) and electrical product safety (1998).

Hong Kong Safety Marks established in 1998 which followed ISO Guide 65. It aims to enhance the product quality in industries and promote product safety to public.

Hong Kong Safety Mark Product Certification flow was introduced

“STC tested” Mark
Some products were achieved “STC tested” Mark such as consumer product regulation (1995), Chinese Medicines (2003) and Nutrition Label (July 2010).

He said that the following points were focused for future development.
i) extension of product certification scope
ii) enhancement of the international mutual recognition
iii) promotion of Hong Kong Safety Mark and “STC tested” Mark to worldwide
iv) following 6 pillar industries direction

The third keynote speaker was Mr. P.C. Chan (Chief Operating Officer, Hong Kong Quality Assurance Agency (HKQAA)) and his topic entitled “Value-added certification through quality audit”.

He shared the seminar of CNCA, CNAS and CCAB in China. The main focus of that seminar was the risk of certification industry between professional and commercial. And he briefed how to enhance recognition of the certification. Moreover, He mentioned ISO 9001 was a good tool for improvement and the future plan was about “Beyond Surveillance Plan”.


Then, the first discussion panel was moderated by Dr. Christopher Leung (Academic Director (Applied Science), Vocational Training Council). During the discussion, all guests agreed “Integrity” was the most important element in the Testing and Certification Industry. Therefore, it should be included in training courses.

Photo with speaker (Mr. P.C. Chan) and friends

(Left: Ms. Joyce Chan (Acting Senior Lecturer, VTC), Mr. Steve Chan (Head of Operation and Training Business, BSI), Mr. P.C. Chan (COO, HKQAA) and I (Quality Manager, HKSTP))


After coffee Break, parallel sessions were started. I selected to attend Session II about Laboratory and Certification Accreditation.

Dr. W.T. Tang (Accreditation Officer, Hong Kong Accreditation Services) was the fourth speaker to present the topic “Laboratory Accreditation on Chemical Testing”. He said that Accreditation Body was authorized by government (or otherwise recognized by stakeholders) which operated according to ISO/IEC 17011.

Dr. Tang introduced the laboratory accreditation flow. He also briefed the measurement traceability in chemistry. The SI unit is mole (mol). Moreover, he mentioned the certified reference materials should be supplied by recognized national institute (e.g. NIST) in which reference materials producer (RMP) should be accredited to ISO Guide 34 and ISO/IEC 17025 in combination.

For Non-Standard method, validation of testing method and measurement should be performed before use. The definition of Validation, Verification and Objective evidence were shown as follows.
- Validation is the confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled (ISO/IEC 17025 clause 5.4.5.1 & ISO 8402:1994)
- Verification is the confirmation, through provision of objective evidence, that specified requirements have been fulfilled (ISO 9000:2000).
- Objective evidence is data supporting the existence or verity of something (ISO 9000:2000).

The following slide showed the requirement for verification or validation in different method types.

The quality control plan for monitoring the validity of results on chemical testing were discussed such as blank, spiked samples, control samples, replicates or duplicates, inter-operator comparison, inter-laboratory comparison and comparison using different techniques.

Mr. K.W. Chen (Senior Accreditation Officer, Hong Kong Accreditation Services) was the fifth speaker and his topic was “Certification and Laboratory Accreditation”.

Mr. Chen introduced the HKAS structure and explained the feathers of product certification. Production certification was issue of a statement (certificate) by a third-party (certification body), based on a decision following review that a product’s fulfillment of specified requirements (product certification scheme) had been demonstrated (by supplier).

The following slides showed the product certification systems under ISO/IEC Guide 67:2004.

At the end, Multilateral Recognition Arrangement of Certification Body was introduced.

During the lunch, Mr. Fong represented Hong Kong General Chamber of Commerce (香港總商會) to give a speech. He said there were three competitive edges in Hong Kong.
i) Established Hong Kong Testing & Certification Brand
ii) Shared the most updated information about the industry
iii) Supported SME by government organizations such as HKPC, VTC, etc.

Professor P.C. Ching (Chairman, Hong Kong Council for Testing and Certification (HKCTC)) gave an honour address. He shared HKCTC vision “Hong Kong to develop into a testing and certification hub in the region by reinforcing the branding of “Tested in Hong Kong, Certified in Hong Kong”.

The first keynote speaker in afternoon session was Mr. Dominic Lam (General Manager, CMA Testing and Certification Laboratories) and his presentation title was “Testing and Certification Industry – Manpower Requirements and Career Opportunities”.

Mr. Dominic Lam said that about 15690 persons engaged in the industry in which 9090 (58%) were professionals and associate professionals whose main duties were to carry out testing, inspection and certification services, where 50% had university degree or above, 33% had higher diploma or diploma / certificate, and 17% for others.

He said it needed about six month on-the-job training for new recruits. (In my experience, I joined CMATCL as QA officer in that post I used 3 month to familiar all calibration works and used another 3 month to familiar all QA related jobs including IQA, Proficiency testing / interlaboratory comparison arrangement, etc.)

The following career path was stated.

He also pleasured VTC to provide HD courses and part-time upgrading courses that were highly relevant to the industry. Then professional Recognition Program proposed by Hong Kong Testing, Inspection & Certification Association (HKTIC) was introduced. The program aimed to encourage young professionals entering into the T&C industry, benchmarking in recruitment and improving professional image of industry.

Lastly, he concluded Passion and Curiosity were the most important elements in the career planning (which more significant than IQ) of Testing and Certification Industry.

The second Panel discussion was moderated by Dr. Lawrence Chan (Academic Director (Engineering), Vocational Training Council). Some audience questioned the cost of SME would be increased if testing items increased by regulation. Prof. Ching said it needed a balance. Increasing testing requirements may be caused by increasing living standard such as food and Chinese medicine.

Photo with Dominic Lam

(Left: Ms. Joyce Chan (Acting Senior Lecturer, VTC), Dr. Christopher Leung (Academic Director, VTC), Mr. Dominic Lam (GM, CMATCL) and I (Quality Manager, HKSTP))


After that I joined the Session IV in the afternoon parallel sessions. Mr. Ronald Lau was the second speaker and his presentation entitled “Recent Developments of Food Testing in Hong Kong”.

He said that an opportunity for testing and certification in food industry after nutrient labeling regulation was effective on 1 July 2010. The number of testing items was estimated to be as high as 2 Million. Moreover, food safety was also focused in mainland and Hong Kong testing industry had potential to provide service in mainland China.

He also introduced some food related certification schemes such as HACCP, ISO 22000 and HKQAA – HCS “Hygiene Control System”. Finally, he concluded the advantages in Hong Kong such as equipment, manpower, cost (it is not advantage, so it must be value-added service), integrity and brand, as well as, one-stop shop service and value-added service.


The last speaker was Prof. Zhao Zhongzhen (Programme Director of BPharm/CM Hong Kong Baptist University) and his topic was “Testing of Chinese Medicine”.

In the beginning, he explained the classification of different types of Chinese Medicines. Why it was important to identify the right Chinese medicine? People would be poison if wrong identification of CM used.

The case of Wuhuacha composition was shared. If one of flowers misused such as “Datura metel L.”, people would be poison.

Many confused CMs in Hong Kong were introduced.

Prof. Zhao introduced 2006 NIH Policy Requirements on Quality of Natural Products for Research as follows.
- Source of materials must be identified
- Plants must be authenticated
- Analysis to rule out contamination must be done.

The Hong Kong Chinese Materia Medica (CMM) Standard was established.

Then he mentioned the facilities / equipments in “Bank of China (Hong Kong) Chinese Medicines Centre”.

DNA Molecular Marker Authentication would be more popular for identifying CMM.

He explained how to select a high quality “杞子” at the end.

Lastly, Dr. Michael Lam (CEO, Hong Kong Quality Assurance Agency) gave a closing remark.

He emphasized three points to keep our industry success.

i) Understand your customer need

ii) Be Professional

iii) Integrity & Trust

For more information:
http://www.vtc.edu.hk/vtc/web/template/event.jsp?fldr_id=1031&content_id=15658

HKCTC Report Summary (Testing & Certification)

Report of The Hong Kong Council For Testing and Certification (HKCTC) entitled “Tested in Hong Kong, Certified in Hong Kong” was released on 31 March 2010. The report provided a three-year market-oriented development plan for the testing and certification industry.

HKCTC aims to develop Hong Kong into a testing and certification hub in the region by reinforcing the branding of “Tested in Hong Kong, Certified in Hong Kong”. Four recommendation categories from the report are summarized as follows.

1) Enhancement of the Accreditation System
- Hong Kong accreditation service is of high standard and has good reputation internationally; therefore, the current mode of accreditation in Hong Kong is recommended to be retained.
- The adequate manpower resource was requested in Hong Kong Accreditation Service (HKAS) in which included training to ensure high professional standards and to provide new accreditation service.

2) Enhancement of the Factors of Production
- This category was separated into four areas: manpower, technology, capital and land.

a) Manpoweri) To cooperate with universities, VTC and the industry to organize seminars, workshops and career talks to enable students to understand about the industry

(Hong Kong Society for Quality (HKSQ) recognized that students, studying chemistry and/or biology, do not have knowledge about the industrial requirements on laboratory operations. Since 2005, a certificated course entitled “Quality Management for Laboratory (QM for Lab)” has been organized by HKSQ and BCH Dept., CityU of Hong Kong. Details at http://qualityalchemist.blogspot.com/2010/04/laboratory-workshop-in-hksq.html
Moreover, the related course in CityU entitled “Bachelor of Engineering (Honours) in Total Quality Engineering (BETQE)” has launched for this need. Details at http://qualityalchemist.blogspot.com/2009/11/hksq-membership-drive-to-beng-hon-in.html)
(Recently, HKSQ has been invited by the Hong Kong Qualifications Framework (HKQF) to participate for developing Quality Framework for Testing, Inspecting and Certification Industry. HKQF – http://www.hkqf.gov.hk/)
ii) To develop voluntary professional recognition on a general or specific front

(The certificate course of “QM for Lab” has been launched since 2005. Then HKSQ has developed the certified professional schemes entitled “Certified Laboratory Quality Specialist (CLabQS)” in 2008. Apart from this certification, Certified Six Sigma Green Belt (HKSQ – SSGB) was established since 2006 and Certified Quality Engineer (HKSQ – CQE) is being developed. Moreover, ASQ certification schemes are also promoted. Details at http://www.hksq.org/cert.htm)
iii) To encourage professors and lecturers to participate as part-time assessor in HKAS

(Some members of HKSQ are HOKLAS technical assessors.)
b) Technologyi) To encourage wider use ITF to the industry
ii) To promote the R&D of testing methodologies and collaborate with institutions on the existing technology infrastructure (such as Science Park, HKPC, the five R&D Centres under ITF and the Hong Kong Jockey Club Institute of Chinese Medicine (HKJCICM))
iii) To increase transfer of technical know-how through HKAS and Gov Lab technical seminars and workshops
iv) To promotion knowledge of international standards by the Product Standards Information Bureau (PSIB)

c) Capitali) To promote wider use of Small Entrepreneur Research Assistance Programme (SERAP) to SMEs in the industry
ii) To step up promotion of HKPC and Science Park facilities available for shared use to testing laboratories

(Hong Kong Science and Technology Park (HKSTP) has 9 laboratories and centres including IC Design and IP Servicing Centre, Probe and Test Development Centre, IC Failure Analysis Laboratory, Material Analysis Laboratory, Solid State Lighting Laboratory, Reliability Laboratory, Photovoltaic Test Laboratory, Biotech Support Laboratory etc. Details at www.lab.hkstp.org )
(Many technical visits to HKSTP were arranged by different organizations including CityU, IIE, HKSQ, HKIE, etc. Details athttp://qualityalchemist.blogspot.com/2010/03/industrial-visit-to-hkstp-laboratories.html
http://qualityalchemist.blogspot.com/2010/01/institute-of-industrial-engineers-hong.html
http://qualityalchemist.blogspot.com/2009/10/cityu-student-visit-hkstp.html
http://www.hksq.org/album.htm
http://www.hkengineer.org.hk/program/home/pink.php?dept=etron )
d) Landi) To monitor closely the impact of Government initiatives to revitalize industrial buildings in the testing and certification industry

(Testing laboratories have special accommodation needs and require purpose-built premises; the Industrial Estates offer a possible solution.)
ii) To keep in view of Government’s plan to increase land supply for the testing and certification industry

(HKCTC discussed whether the land in Lok Ma Chau Loop would assist the development of the industry.)
3) Mature Trades & Selected Trades
a) Five Mature Trades are identified as Textiles, Clothing and Footwear, Toys and Games, Electrical Products, and Medical Testing. Development of testing in these trades is more mature and it will continue to be enhanced through the recommendation of item 1 and 2.
b) After consulting various sectors, the following four Selected Trades are considered to be good opportunities:
i) Chinese Medicine
Proprietary Chinese Medicine (pCm, 中成藥)
Chinese Herbal Medicine (中藥材)
ii) Construction Materials
To promote wider adoption of product certification to the construction industry
iii) FoodTo rise potential demand from Government’s initiatives
iv) Jewellery
To raise Hong Kong’s technical expertise and international standing in the testing to jewellery

4) Emerging Trades- Environmental Protection and Information and Communications Technologies (ICT) are two emerging trades to be considered by HKCTC.

a) Environmental Protection
HKCTC will set up a forum to work together with EPD and industry stakeholders.
b) Information and Communications Technologies (ICT)HKCTC will also set up a working group to provide a forum for different sectors of the trade.

One of the important tasks is the recognition of assessment results from mainland. Since CEPA established a platform for cooperation between the Mainland and Hong Kong, HKCTC recommends the Commerce and Economic Development Bureau to continue pursuing discussions with the Mainland authorities through CEPA to seek their agreement to recognize testing reports of accredited laboratories in Hong Kong.

Finally, HKCTC will follow-up all recommendations; moreover, the “Tested in Hong Kong, Certified in Hong Kong” branding should be the theme of future promotional activities.

(HKCTC organized a consultation forum with relevant stakeholders to collect industrial opinions on 27 Nov 2009. Over 150 participants from about 90 organizations attended. They included representatives from various professional associations such as HKSQ (Page 5, item (d) in the HKCTC report). HKSQ’s views had been shared during the forum and a report was submitted to HKCTC afterward.
The Consultation Forum summary posted athttp://qualityalchemist.blogspot.com/2009/11/hong-kong-council-for-testing-and.html
HKSQ’s suggestions to the testing and certification industry posted at http://www.hksq.org/HKSQ_Suggestion_to_HKCTC_20100112.pdf. )

The following photo was taken in the forum in which I was sharing the opinion on behalf of HKSQ. (Photo comes from HKCTC website)



For more information about HKCTC report:http://www.itc.gov.hk/en/hkctc/related_document.htm

Laboratory Workshop in HKSQ certification course “QM for Lab”

“Quality Management for Laboratory (QM for Lab)” organized by Hong Kong Society for Quality (HKSQ) and Dept. of Biology and Chemistry, The City University of Hong Kong (BCH, CityU HK). Two Laboratory Workshops were included for student to practice the calibration of equipment, glassware, etc.

The first workshop aims to practice the fundamental calibration in chemistry related laboratory equipment and its uncertainty.

Related to Mass – Calibration of Analytical Balance





Related to Temperature – Calibration of Thermometer (Room temp and zero point)

Related to Volume – Calibration of V-flash and pipette

The second workshop aims to create the calibration curve using Inductively Coupled Plasma optical emission spectrometry (ICP-OES) and calculated the uncertainty of the calibration curve.

Related to Concentration – Preparing calibration curve through dilution of stock solution.

ICP analysis performed

After these two workshops, students could learn the foundation of calibration and uncertainty of measurement.

Related articles:
1) Introduction of Quality Management for Laboratory organized by Hong Kong Society for Quality (HKSQ): http://qualityalchemist.blogspot.com/2009/12/certificate-course-on-quality.html
2) Industrial Visit to HKSTP Laboratories: http://qualityalchemist.blogspot.com/2010/03/industrial-visit-to-hkstp-laboratories.html
3) Industrial Visit to Standards and Calibration Laboratory (SCL): http://qualityalchemist.blogspot.com/2010/03/industrial-visit-to-standards-and.html

For more information:
http://www.hksq.org/