In the beginning, Dr. George HK LAU (Programme Leader & Associate Professor, Testing and Certification, School of Science & Technology, OUHK) gave a welcoming address. He said that OUHK had more than 6000 full time student and then he introduced OUHK new program and laboratories for T&C industry.
Then Ir. Dr. Angus CHEUNG (Chairman, The Institution of Engineering and Technology, Hong Kong Branch) presented an opening speech. Ir. Dr. Cheung pointed that Pharmaceutical and Food Safety were major concerned in Society.
After that IET and MILESAA presented souvenir to guest speakers. Ms. Minda Chiang received souvenirs. She was invited to be speaker and represented HKSQ.
Group photo of all speakers and representatives of organizers
The first speaker was Ms. Minda CHIANG (Hons Secretary, HKSQ) and her topic entitled "Good Manufacturing Practices (GMP) in Pharmaceutical Manufacturing". Firstly, she explain why GMP needed for drug industry and shared the history of drug accidents which caused the born of GMP.
Minda introduced what was GMP. It was part of QA to ensure that Medicinal products were consistently produced and controlled to the quality standard appropriate to their intended use and as required by the marketing authorization or product specification. She mentioned the values of GMP in Drug Industry included Safety, Identity, Strength, Efficacy/Potency, and Purity. The following diagram showed the Pharmaceutical Manufacturing Quality System.
After that Minda briefed the different requirements, included GLP, GCP and GMP, in different stages of drug development. For different products, their GMP would base on different requirements and showed below.
- Food (Processed Food): 21 CFR 110 / ISO 22000
- Cosmetic: ISO 22716
- Medical Device: 21 CFR 820 / ISO 13485
- Drug: PIC/S GMP / WHO GMP / Eudra GMP / US 21 CFR / HK GMP / SFDA GMP, etc.
Minda pointed out some foactors impacting the Pharmaceutical Quality System (Pharm QS) included emerging regulations and guidance, innovations that might enhance the Pharm QS, and changed in business environment and objectives. Finally, she concluded the concept of GMP aimed to diminish risk such as cross-contamination & mix-up. The quality and safety of medicines was only sustained by responsible people and continuous improvement.
The second speaker was Dr. Fred LEE (Assistant Professor, School of Science and Technology, OUHK) and his presentation named "Food Testing - Challenges and New Technologies". Dr. Lee reviewed GMP, Food Safety and Testing. Then he introduced modern testing technologies for food.
Dr. Lee said the food testing technology was expected to be rapid, high-throughput, automation, ease of use, high sensitive & specificity, and competitive cost. Then he introduced three kind of modern technologies such as Mass Spectrometric (MS)-based, Serological-based and Molecular-based technologies. The biosensor used Transgenic Medaka for biological testing. (Details see previous seminar at http://qualityalchemist.blogspot.hk/2013/04/technical-seminar-on-product-testing.html)
Finally, Dr. Lee concluded the challenges and limitations included validation, standard reference culture techniques, viable, training & expertise, cost, regulation approval, reference materials and harmonized standard methods.
Before the tea break, Ir. MK Lam (IET Membership Development Committee and Vice Chairman of MILESAA) gave membership drive presentation.
The last speaker was Mr. Raymond YUE (Certification Manager, Hong Kong Certification Centre Ltd.) and his presentation topic was "HK Safety Mark - Medical Devices).
Dr. Lee briefed different Food Testing included Composition Analysis (e.g. Total fat), Contaminants (e.g. Pesticides), Natural Toxins (e.g. Marine Toxin), Additives (e.g. Sweeteners), Food Contact Materials (e.g. Leachable Metals), Food Authentication (e.g. Species ID by DNA method), Microbiological Test (e.g. Food Borne Pathogens) and Genetically Modified (GM) Food. The following diagram summarized recently key food safety incidents.
Dr. Lee said the food testing technology was expected to be rapid, high-throughput, automation, ease of use, high sensitive & specificity, and competitive cost. Then he introduced three kind of modern technologies such as Mass Spectrometric (MS)-based, Serological-based and Molecular-based technologies. The biosensor used Transgenic Medaka for biological testing. (Details see previous seminar at http://qualityalchemist.blogspot.hk/2013/04/technical-seminar-on-product-testing.html)
Finally, Dr. Lee concluded the challenges and limitations included validation, standard reference culture techniques, viable, training & expertise, cost, regulation approval, reference materials and harmonized standard methods.
Before the tea break, Ir. MK Lam (IET Membership Development Committee and Vice Chairman of MILESAA) gave membership drive presentation.
The last speaker was Mr. Raymond YUE (Certification Manager, Hong Kong Certification Centre Ltd.) and his presentation topic was "HK Safety Mark - Medical Devices).
In the beginning, he introduced the requirement in Testing, Inspection and certification to us. Then he explained the requirement on ISO/IEC Guide 65 & 67. He mentioned the product certification (included medical device) had three characteristics:
1. Testing according to standards, local regulations etc.
2. Assessment of the production process and quality system
3. Surveillance - samples testing taken from the market or from supplier's stock or from a combination of manufacturing assessment or both.
The whole process of supply chain was shown as follows.
Since HKSQ had a career talk for young students in this afternoon, we left early before the seminar completed.
Reference:
OUHK - http://www.ouhk.edu.hk/
IET (HK) - http://www.theiet.org.hk/
MILES Alumni Association - http://www2.ise.polyu.edu.hk/milesaa/mission1.asp
HKSQ - http://www.hksq.org/index.asp
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