Quality Alchemist (品質煉金術師): Biotech Training

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2015年4月11日星期六

HKSQ Pharmaceutical Good Manufacturing Practices (GMP) Workshop

Hong Kong Society for Quality (HKSQ) organized the 1st Workshop entitled “Pharmaceutical Good Manufacturing Practices (PGMP)” from 28th February to 11th April 2015 (4x Saturday). The aim of this workshop was to introduce the principles and practices of GMP applied in different regions, including PIC/S GMP, Eudra GMP, US GMP, Heath Canada Guidelines, WHO GMP, HK GMP.

The trainer was HKSQ Secretary Ms. Minda Chiang who is ASQ Certified Pharmaceutical GMP Professional (ASQ CPGP) with more than 15 years in QA of GMP pharmaceutical manufacturing company. The location was in the Innohub which was employed our co-op member – Mr. Simon Tong’s office in Tsuen Wan.

During the workshop, it is not only for theory and regulation knowledge, but also the practical exercise such as cleanroom practices.

The first class of HKSQ PGMP Workshop group photo was taken for memory.

2010年12月2日星期四

Medical Laboratory QM Training - ISO 15189

I attended the ISO 15189 training organized by HKSA from 29 November to 1 December 2010. The course was performed by New Zealand Quality College which was the training division of International Accreditation New Zealand (IANZ).
The speaker was Ms. Shelli Turner (Programme Manager - Medical Testing, IANZ).

The diagram showed the syllabus of the training course in which included all managerial and technical requirements.

We needed to do a group exercise and presented the results and solutions.

The last day, Ms. Shelli Turner presented the training certificate to us.

For more information:
IANZ - http://www.ianz.govt.nz/
New Zealand Quality College - http://www.nzqc.co.nz/

2010年5月23日星期日

Lectures on Pharmacy Legislation (Lec 05)

I attended the last Lecture of Pharmacy Legislation on 14 May 2010. The topics were “Dangerous Drugs Ordinance (Cap. 134) on Classification & Sale of Dangerous Drugs (DD)”.

Definition of DD is drugs or substances specified in First Schedule, Part I.
It included the following substances.
1. a) Opioids (Opioids are narcotic drugs that are generally prescribed to manage pain.) (鴉片類)
- Benzodiazepines (It relieves nervousness, tension, and other symptoms by slowing the central nervous system.) (苯二氮是一種抗焦慮症的藥)
- Hypnotics (An agent that causes sleep) (安眠藥)
- Amphetamines (A colorless, volatile liquid, C9H13N, used as a central nervous system stimulant in the treatment of certain conditions, such as attention deficit hyperactivity disorder, depression, and narcolepsy, and abused illegally as a stimulant.) (苯丙胺 (alpha-methyl-phenethylamine) - 俗稱安非他命)
- Hallucinogens (A drug or chemical that causes alterations in perception (usually visual), mood, and thought.) (迷幻劑)
b) Structurally derived from tryptamine (色胺,β-吲哚基乙胺)
c) Structurally derived from phenethylamine (苯乙胺)
d) Structurally derived from fentanyl (芬太尼, 一种止痛剂)
e) Structurally derived from pethidine (哌鱼替啶)
2. any stereoisomer of (1) not being dextromethorphan or dextrophan;
3. any ester or ether of (1) or (2);
4. any salt of (1), (2) or (3);
5. concentrate of poppy straw (罌粟稈)
6. medicinal opium (鴉片)
7. prep., mixture, extract or other substance containing (1) to (6);
8. opium or opium water;
9. coca leaves (古柯葉);
10. poppy straw (罌粟稈);
11. cannabis (大麻) & cannabis resin (大麻樹脂)

First Schedule, Part II is shown as follow.
13. Preparation of not more than (<) one of the substances in (19) or (20) (in Part III), when a) no or negligible risk of abuse & cannot be recovered by readily means; & b) <100mg per dose unit & <0.5% in undivided preparation.
14. Preparation of <0.1% of cocaine (Cocaine is a highly addictive central nervous system stimulant extracted from the leaves of the coca plant, Erythroxylon coca. -可卡因), & (a);
15. Preparation of medicinal opium or morphine (嗎啡) with <0.2% morphine, & (a);
16. Preparation <> atropine sulphate (硫酸阿托品) 25mcg;
17. Dover’s powder containing 10% opium powder;
18. Mixtures containing < one of the preparations in (13) to (17).

First Schedule, Part III is shown as follow.
19. The following substances namely:
- Acetyldihydrocodeine (It is an opiate derivative developed in Germany around 1900 as a cough suppressant and analgesic.) (醋氢可待因)
- Dextropropoxyphene (It is an analgesic in the opioid category.) (右旋丙氧芬, 一种镇痛药)
- Ethylmorphine (It (also known as codethyline, dionine, and ethyl morphine) is an opiate narcotic analgesic (pain killer).) (乙基嗎啡)
- Nicocodine (It developed as a cough suppressant) (烟酰可待因)
- Pholcodine (It helps suppress unproductive coughs and also acts as an antifungal agent.) (福尔可定)
- Codeine (An alkaloid narcotic, C18H21NO3, derived from opium or morphine and used as a cough suppressant, analgesic, and hypnotic.) (可待因, 採自鴉片的鎮痛止咳劑)
- Dihydrocodeine (双氢可待因)
- Norcodeine (去甲可待因)
- Propiram (丙吡胺, 镇痛药)
20. Any salt of a substance in (19);
21. Any preparation … containing any of substance in (19) or (20);
22. Any preparation in First Schedule, Part II.

First Schedule, Part IV is shown as follow.
Preparation <0.1% cocaine being a preparation compounded with one or more other ingredients in such a way that the preparation has no or a negligible risk of abuse and that the substance contained therein cannot be recovered by applicable means or in a yield which would constitute a risk of health.

Summary figure is shown.

Legal Classification of Preparation containing DD
e.g.
Codeine Syrup 30mg/5ml % Legal Classification
Codeine Syrup 9mg/5ml
Codeine 15mg Tablet (500mg)
Pholcodine Syrup 0.9%

Dangerous Drugs required registering and preserving registers & documents for 2 years from the last entry date.

For more information:
Pharmaceutical Services Website at www.psdh.gov.hk

2010年5月13日星期四

Lectures on Pharmacy Legislation (Lec 04)

I attended Lecture 4 on 7 May 2010. The topics were “Licensing of Authorized Sellers of Poisons and Listed Sellers of Poisons” and “Import / Export Control of Pharmaceutical Products and Dangerous Drugs”.

The following laws governed the operation of a dispensary:
- Pharmacy and Poisons Ordinance Cap.138
- Antibiotics Ordinance Cap.137
- Dangerous Drugs Ordinance Cap.134
- Undesirable Medical Advertisements Ordinance Cap.231
- Public Health and Municipal Services Ordinance Cap.132
- Chinese Medicine Ordinance Cap.549
- Trade Descriptions Ordinance Cap.362
- Control of Chemicals Ordinance Cap.145
- Protection of Endangered Species of Animals and Plants Ordinance Cap.586
- Business Registration Ordinance Cap.310
- The Companies Ordinance Cap.32
- Waste Disposal Ordinance Cap.354
- Employees’ Compensation Ordinance Cap.282
- Mandatory Provident Fund Schemes Ordinance Cap.485
- Pesticides Ordinance Cap.133, … etc.

The following figure showed the type of companies and its legal person.

Authorized Seller of Poisons (ASP) (獲授權毒藥銷售商 – 俗稱 “藥房牌”)
- A business comprising the retail sale of poisons carried on by a registered pharmacist or by a body corporate or an unincorporated body of persons shall be an ASP if the actual sale of poisons is conducted on premises duly registered under the Pharmacy and Poisons Ordinance by a registered pharmacist or in his presence and under his supervision.
Licensing Conditions in Form 16 are shown as follows:
i) ASP shall produce his certificate of registration of premises for inspection.
ii) The receipt of Part I Poisons or Antibiotics shall be attended to and signed by the registered pharmacist.
iii) PIS1 Poisons & Antibiotics shall be kept in a locked receptacle, the key to which shall be kept only by the registered pharmacist.
iv) Record of transactions involving Psychotropic Substances shall be maintained.

- An ASP may display at the premises, where the retail sale of poisons is conducted, a logo in the prescribed form in the Eighth Schedule (Form 17).

Listed Seller of Poisons (LSP) (列載毒藥銷售商 – 俗稱 “藥行牌”)
- The Pharmacy and Poisons Board (the Board) shall keep a list of persons who, not being ASP, to be entitles to conduct the retail sale of a class or classes of poisons included in Part II of the Poisons List.

Example of LSP: medicine company (e.g. Waston’s & Mannings), Supermarket (e.g. Park’N, Wellcome), Department store (e.g. Sogo, Wing On), Convenience store (e.g. 7-Eleven, Circle K), Cosmetic company (e.g. Sa Sa), and Household shop (e.g. Jusco $10 Plaza).

Import / Export Control of Pharmaceutical Products were governed by the following laws:
- Import and Export Ordinance Cap.60
- Dangerous Drugs Ordinance Cap.134
- Antibiotics Ordinance Cap.137
- Pharmacy and Poisons Ordinance Cap.138

Under the Import and Export Ordinance Cap.60 of the Laws of Hong Kong, all imports and exports of pharmaceutical products and medicines (includes dangerous drugs) must be covered by a relevant and valid import/export license that is issued by the Director-General of Trade and Industry.

The following requirements showed the application of Import License.
- Import License Form 3 (blue) together with the following relevant license/permit or combination for the appropriate application:
i) Certificate of Registration as an Importer and Exporter of Pharmaceutical Products (Form 14)
ii) Wholesale Poisons License (Form 1)
iii) License for Manufacturer
iv) Antibiotic Permit
v) Certificate for Registration of Premises

The following requirements showed the application of Export License.
- Export License Form 6 (white) together with the following relevant license/permit or combination for the appropriate application:
i) Certificate of Registration as an Importer and Exporter of Pharmaceutical Products (Form 14)
ii) Wholesale Poisons License (Form 1)
iii) License for Manufacturer
iv) Antibiotic Permit
v) Certificate for Registration of Premises

For Dangerous Drugs (D.D.), including non-pharmaceutical products, it required:
- Wholesale Dealer’s License to Supply Dangerous Drugs
- License to Manufacture Preparations of Dangerous Drugs

Application for Import License Additional Requirements
- The product is registered in Hong Kong – Certificate of Drug/Product Registration (Form 7)
- For Clinical Trial – Certificate of Clinical Trial / Medicinal Test

Exceptions:
- Pharmaceutical raw material imported by manufacturer for own manufacturing
- Import for re-export
- Sample (reasonable quantity) for registration purpose or clinical trial application
- For treatment of named patient(s) or particular animal(s)

For importing D.D. (Psychotropic), international matching was required.

The following figure showed the procedure of dangerous drug import and export.

For more information:
Pharmaceutical Services Website at www.psdh.gov.hk

2010年5月10日星期一

Lectures on Pharmacy Legislation (Lec 03)

Lecture 3 started on 30 April and it separated into two sections. The first one was “Manufacture of Pharmaceutical Products” and the second one was “Registration of Pharmaceutical Products & Substances”.

The definition of Manufacture was shown as follows:
- Preparation of pharmaceutical products for sale or distribution but shall NOT include the individual dispensing on a prescription or otherwise or any Pharmaceutical Products
- Repackaging for sale or supply falls within the limit of the definition of “Manufacture”

There were 40 holders of a manufacturer’s license in Hong Kong at the end of 2009. They were:
- 25 Certified GMP Manufacturers (Only 3 to manufacture sterile preparations)
- 12 Contract-out Manufacturers
- 6 Vet. Pharmaceutical Product Manufacturers.

Application for Manufacturer License(s) should include the following information:
* Site Master File
- Name and address of the applicant
- Activities related
- Premises (Model and Capacity of the equipment and facilities, as well as, floor-plan)
- Qualifications of Key Personnel
- Records

Key Personnel Structure and their qualification requirement were shown below.
i) Quality Assurance / Authorized Person
Authorized Person (AP) should be HK Registered Pharmacist with at least 3 year of relevant GMP pharmaceutical manufacturing / quality control experience.
ii) Quality Control & Production
The head of Production & QC should at least have:
- BSc in relevant science subject with at least 3 years of relevant GMP pharmaceutical manufacturing / quality control experience; or
- HD in Pharmaceutical Technology, or with at least 3 years of relevant GMP pharmaceutical manufacturing / quality control experience; or
- Certificate in Dispensing Studies with at least 2 years of relevant GMP pharmaceutical manufacturing / quality control experience

Health and Hygiene of workers required to avoid contamination of productions as follows:
- Medical Examination & History records
- Report of sickness or injury
- Protective clothing
- Provision of isolated eating, smoking and rest areas
- Training and education of technical staffs and employees

Premises for manufacturing requirement for fittings and machinery included:
- Permit Ready and Efficient Cleaning of all surfaces
- Premises in a Clean and Orderly condition
- Controlled Temperature and Humidity
- Separate Aseptic Area for Parenteral Products

Quality Control included:
- Testing of each batch of raw material to ensure identity and purity
- Testing of each batch of finished product to ensure identity and potency
- Parenteral Products in accordance with British Pharmacopoeia or other Pharmacopoeia
- Control sample kept for not less than normal shelf life or 2 years after the last transaction
- Recall System

Labeling of products and maintenance of records were also required.

The history of Hong Kong GMP was briefed as follow. A working party on GMP for manufacturers formed in 1993. Then HK GMP Guidelines for Pharmaceutical Products was published in 1995. The implementation schedule showed:
Phase I To be completed before 31 Dec 1996 (Documentation Phase)
Phase II (SOP in place)
IIa (31 Dec 1998) (Personal hygiene & training for technical staffs)
IIb (31 Dec 1999) (Handling of materials, Documentation and GMP for API)
IIc (31 Dec 2000) (Principles and practices relating to QC)
Phase III (31 Dec 2002) (HK GMP implemented)

The second topic was “Registration of Pharmaceutical Products & Substances”.(USA – CFR Title 21 Sec. 314.3; UK – Directive 2001/83/EC)

Pharmaceutical product included Poisons, Antibiotics, Dangerous Drugs, Product not belong to the above such as vitamins and minerals. The definition of a Pharmaceutical Product was stated in “Guidance Notes on Classification of Products as Pharmaceutical Products” at www.psdh.gov.hk .

The registration of pharmaceutical product based on Reg. 36(1) of Pharmacy & Poisons Ordinance to ensure the Quality, Safety and Efficacy.

During the application for registration, filled Form 6 and submitted the following supporting documents are requested.
i) complete master formula
ii) manufacturer’s license
iii) GMP certificate
iv) Free sale certificate
v) Certificate of analysis (CoA)
vi) Method of analysis
vii) Specifications
viii) Stability test data
ix) Clinical and scientific papers

The registration certificate is valid for a period of 5 years.

For more information:
Section1:
- Sec. (2) of the Pharmacy and Poisons Ordinance, Cap. 138.
- Reg. (29) – (35), Part VII of the Pharmacy and Poisons Regulations, Cap. 138A.
- Sec. (4-6) of the Dangerous Drugs Ordinance, Cap. 134.
Section2:
- Pharmacy & Poisons Ordinance – Section 29(q)
- Pharmacy & Poisons Regulations – Part VIII

2010年4月28日星期三

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/

2010年4月25日星期日

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/

2008年12月11日星期四

Laboratory Biosafety Training

I attended a course named “Laboratory Biosafety”, organized by Hong Kong Association for Testing, Inspection and Certification Ltd. (HKTIC) on 11 Dec 2008.

The trainer was Mr. Y.K. Wan and the course scopes included Risk Assessment, Laboratory Practices, Biosafety cabinet, Sterilization and Laboratory Design.

Unacceptable risks can be found during risk assessment. Risk assessment has 5 steps:
Step 1 – gathering information
Step 2 – evaluating risks to health
Step 3 – deciding what needs to be done to control or prevent exposures
Step 4 – recording the assessment
Step 5 – reviewing the assessment

Programs & Committees for laboratory Biosafety are:
- Biosafety Committee
- Biological Agent Inspection
- Workplace Complaints
- Incident Review
- Medical Surveillance
- PPE
- Respiratory Protection
- Equipment Maintenance
- HEPA Filter-containing Equipment Certification
- Safety Training (including Animal Handling, GLP, Spill Control, Signage)
- Emergency Response
- Construction and Renovation
- Facilities Maintenance
- Pest Control
- Waste Control, Treatment and Disposal

Strategic laboratory management of risks on handling biological materials is:
· to develop safety policy and manual
· to implement safety policy
· to determine the risks and the associated Biosafety levels
· to promote safe operational practices in laboratories
· to maintain containment facilities and equipment
· to control import, export, application, and inventory of biohazardous agents
· to provide training to staff and visitor
· to monitor, review, advise the Biosafety management

Biohazardous substances is defined as:
The biological agents such as animals, plants, microorganisms, or the derived substances whatever nature survived or genetically modified that are able to produce deleterious effects on humans, animals, and plants.

Laboratory-acquired infections are transmitted:
- from the agents being directly handled
- by the person who do the laboratory work
- as the result of escape of agents

It may be caused by:
- Inadequate risk assessment
- Inadequate knowledge of disease (e.g. route of infection)
- Improper handling materials (e.g. hidden pathogens)
- Improper handling contaminated equipment and apparatus
- Improper facilities or practices
- Insufficient decontamination
- Insufficient personal protection

One of routes of transmission is Zoonoses which spread between people and animals. Needlestick handling is one of the high risk items. Needle safety should be taken care (Don’t put needle in your lab coat.)

There are four Biosafety Levels (BSL) in the following table.

Biohazard Symbol and label should be used properly.

The Equipment- and technique- related hazards included “Inoculating loop”, “Pipettes”, “Hypodermic needles and syringes”, “Centrifugation”, “Blending, homogenizing and shaking”, “Opening cultures and ampoules”, “Pouring infectious material”, “Breakage and spillage”, “Sharps”, “Ultrasonic devices”, “ELISA equipment”, “Liquid nitrogen”, “Water bath”, “Autoclaves and incinerators”, “Flow cytometer / cell sorter”, “Cryostat microtome”, “Films and smears for microscopy”, “Automated equipment”, etc.

Laboratory Animal should be taken attention!

Handling biohazardous substances, doubled gloves should be used.

Based on EPD – Practice Notes on the Disposal of Clinical Waste at Landfills, the Solid Clinical / Biological Wastes are classified as follows:
Type 1 – Contaminated Sharps
Type 2 – Laboratory Wastes
Type 3 – Human and Animal Tissue
Type 4 – Infectious Material
Type 5 – Soiled Dressings
Type 6 – Cytotoxic Wastes
Type 7 – Pharmaceutical and Chemical Wastes

Disposal of biological waste should be noticed:
- Register bag packaging system
- Sterilization / Disinfection / Decontamination is required
- Wastes are packaged in leak proof containers
- Sharps must be put into sharp box
- Carcass / organs / tissues are frozen
- Adequate absorbent is placed in package
- Maximum weight of each package are less than 20kg.

Emergency contingency plans has Manual (or SOP / Guidelines) and Training for
- Spillage
- Loss of biological agents (e.g. patient sample)
- Malpractice (e.g. labeling)
- Shutdown of facilities (e.g. exhaust air treatment equipment)
- Security
- Bioterrorism

Different types of Biosafety Cabinet (BSC) were introduced.

The level of sterilant and Disinfectant power are shown.

Lastly, trainer introduced the laboratory design. Risk assessment of building is showed below.

The autoclave is designed with double-door and unidirectional material flow.

The course content was so many and not recorded in details. If you are interested in, please visit HKTIC website at http://www.hktic.org/ to join the next round training.

2007年12月5日星期三

Bio-Quality Management System (Bio-QMS)

What is Bio-QMS?
A management system direct and control an organization by policy and objective with regard to bio-quality. Bio-quality is the degree to which a set of inherent properties of a product, system or process fulfills biotechnology related requirements including bio-risk, bio-safety and bio-security. For biotechnology related product, system or process, it has almost operated in laboratory environment such as biochemistry test, microbiological / culture study, DNA & RNA recombination, GMO study, etc.

Bio-risk is the probability of an adverse health effect as a result of exposure to a biohazard substance. The risk involves interactions among agent, host and environment. Therefore, a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product life cycle and safety, as well as, security should be concerned.

Laboratory Bio-safety could be interpreted as containment principles, technologies and practices to prevent unintentional exposure to pathogens and toxins, or their accidental release.

Laboratory Bio-security could be interpreted as institutional and personal security measures designed to prevent loss, theft, misuse, diversion or intentional release of pathogens and toxins. Laboratory Bio-security touches many area including physical security, personnel security, material control & accountability, transport security and information security.

Therefore, Bio-QMS is an integrated management system to ensure safe handling and free contamination risk of micro-organisms and the products of biological processes through the establishment and implementation of the policies on bio-quality (bio-risk, bio-safety and bio-security).

The followings photos show a simulation handling process of bio-agent spill in BSL3 lab.

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Quality Alchemist (品質煉金術師)