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Monday, February 25, 2008
Sunday, February 10, 2008
PS 9004: a guide to the GMP requirements of PS 9000:2001 pharmaceutical packaging materials
PS 9004, developed by the CQI's Pharmaceutical Quality Group, is a comprehensive guide into the reasons for the specific pharmaceutical GMPs stated in PS 9000 and the rationale for some of the clauses in technical agreements for the supply of packaging material. It includes a range of authoritative reference sources and case studies, which illustrate real-life problem scenarios. With its rich source of material and guidance to trainers, it will be a valuable aid for the education and training of appropriate personnel within the packaging materials supply chain and pharmaceutical industries.
PS 9004 has been developed because suppliers to the pharmaceutical industry do not always appreciate fully the reasons why the GMP requirements defined in PS 9000 are needed. The guide provides in clear language the appropriate reason for each critical requirement and sources of further useful reference information. It is intended primarily to help with the education and training of supplier's staff but will also be useful for the training of appropriate pharmaceutical industry staff. The document has been developed by a team of pharmaceutical and supply industry personnel led by Roy Evans.
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WHO
About WHO
"Our greatest concern must always rest with disadvantaged and vulnerable groups. These groups are often hidden, live in remote rural areas or shantytowns and have little political voice."Dr Margaret ChanWHO Director-General
WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.
In the 21st century, health is a shared responsibility, involving equitable access to essential care and collective defence against transnational threats.
The WHO agenda A six-point agenda to improve public health
The role of WHO in public health The Organization's core functions
Governance of WHO World Health Assembly, Executive Board and Constitution
History of WHO Origin of WHO and historical resources
People and offices The Organization's structure and presence
Resources and planning Budget, fund sources and expenditures
Working for health
An introduction to WHODownload [pdf 1.24Mb]
Contact information
World Health Organization
Avenue Appia 20CH - 1211 Geneva 27
Switzerland
Tel.: +41 22 791 2111
Fax.: +41 22 791 3111
More information
KEY WHO INFORMATION
Director-GeneralDirector-General and senior management
Governance of WHOWHO Constitution, Executive Board and World Health Assembly
Media centreNews, events, fact sheets, multimedia and contacts
International travel and healthPublication on travel risks, precautions and vaccination requirements
World Health ReportAnnual report on global public health and key statistics
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Thursday, February 07, 2008
Tuesday, January 22, 2008
Saturday, January 19, 2008
HONEY
Introduction :
Honey is a treasure chest of nutritional values and medicinal remedies. Honey is a golden colored syrupy substance made by bees from the nectar of flowers. The quality of honey depends on the prevailing flower blossom. Honey is healthier compared to refined sugar since honey has traces of minerals and vitamins. Honey contains fewer calories and carbohydrates than sugar. Honey contains sugars in the form of glucose and fructose that gives the sweetness. We bring to you honey from the tribal forests of Orissa as well as from the hills of Khandamal.
USP : At Organic.co.in we are into Polyflora Honey both cultivated and wild type, Uniflora Honey i.e. Karanj honey (Pongamia pinnata-source) has relatively high viscosity, has a very good taste and also of high medicinal values, well documented in our Ayurvedic System of Medicines.
Our honey is 100% Organic certified USDA - NOP, we adhere to High QC standards as per AGMARK and BIS (Bureau of Indian Standards) and above all our Extraction Unit is GMP certified. We offer customized and contract manufacturing as per customer requirement.
Product Description :
Honey is "manufactured" in one of the world's most efficient factories, the beehive. Bees may travel as far as miles and visit more than two million flowers to gather enough nectar to make just a pound of honey. The clearer is the honey the higher the proportion of fructose present in it; although, honey will almost always granulate if it is kept long enough. Heating can make it loose.
The color and flavor of honey differ depending on the bees' nectar source (the blossoms). In fact, there are number of unique kinds of honey in the Orissa's Tribal, originating from such diverse floral sources as Clover, Eucalyptus and Orange Blossom. In general, lighter colored honeys are mild in flavor; while darker honeys are usually more robust in flavor.
Honey is primarily composed of fructose, glucose and water. It also contains other sugars as well trace enzymes, minerals, vitamins and amino acids.
Biological Details : The simple components of honey are fructose and glucose (sugars), plus water, pollen, organic acids and various proteins. The food chemists define honey as the nectar and saccharine exudations of plants, gathered, modified and stored in the comb by honeybees. The flavor of honey all depends on which flower (plant) the bee gathered the nectar. There's a wide variety of bee honey.
Benefit to the Environment: Honeybees in this area directly influence 25-30% of the reproductive success of the flora. The flora depends on the bees for pollination, and in turn, flora provides seeds and fruit for their own reproductive success and as food for other organisms.
Area of procurement : We procure our Honey from the tribal forest of Orissa like: - Phulbani, Koraput, Keonjhar, Rayagada, Kalahandi, Palhara, Thakurmunda, Ganda Nali etc. Our Tribals go into the dense forest to collect the Natural Honey directly from Honey-Combs. The Forest honey mostly from rock bee hives and tree bee hives, collected by Tribals is procured by forest or Tribal Corporation as a minor forest produce. Quite a large quantity is also collected by groups or individuals on their own. The method of collection varies according to the nature of the bee species, location of the nest site and the local socio-economical conditions. Honey is usually pressed out of the comb by hand and some people press out the honey using cloth pieces. But in our unit Honey is extracted in honey extractors.
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WHO GMP
Good Manufacturing Practice
Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.
Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself.
An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US).
Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).
In the US, the phrase "current good manufacturing practice" appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.
Contents
1 The World Health Organization version
2 Enforcement
3 Other Good Practices
4 See also
//
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GMP Question and Answers
Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.
Poor quality medicines can damage health
A poor quality medicine may contain toxic substances that have been unintentionally added. A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.
GMP helps boost pharmaceutical export opportunities
Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.
What is GMP?
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
Is GMP necessary if there is a quality control laboratory?
Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
Can manufacturers afford to implement GMP?
Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.
WHO works to strengthen GMP
WHO GMP guidelines are available online. If you require more information, please contact the WHO representative in your country, your WHO regional office or WHO headquarters in Geneva.
Enquiries:
For further information please contact Dr S. KoppE-mail: Kopps@who.int
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WHO GUIDE to GMP
Sunday, December 30, 2007
GMP Guide
PDF]
A WHO guide to good manufacturing practice (GMP) requirements
File Format: PDF/Adobe Acrobat - View as HTML(The Guide to WHO GMP Requirements, Part 1: Standard Operating Procedures and Master. Formulae includes information on the general requirements for the ...www.who.int/vaccines-documents/DocsPDF/www9666.pdf - Similar pages -
US FDA/CDRH: Good Manufacturing Practices (GMP) / Quality Systems ...
The current Good Manufacturing Practice (GMP) requirements set forth in the .... Through a policy statement, FDA may decide not to apply GMP requirements to ...www.fda.gov/cdrh/devadvice/32.html - 40k - Cached - Similar pages -
US FDA/CDRH: Good Manufacturing Practice / Quality Systems
FDA Talk Paper Announcing the GMP Final Rule; The Good Manufacturing Practice (GMP - Quality System Regulation) Final Rule Text PDF ZIP. Design Controls ...www.fda.gov/cdrh/comp/gmp.html - 10k - Cached - Similar pages -
What Is GMP?
Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. ...www.gmp1st.com/gmp.htm - 10k - Cached - Similar pages -
[PDF]
A Guide to the GMP requirements of PS9000:2001 Pharmaceutical ...
File Format: PDF/Adobe Acrobatand easy to follow guide explains further the GMP requirements of PS 9000. ... requirements of ISO 9001 and the additional GMP requirements of PS ...www.thecqi.org/downloads/ps9004_complete.pdf - Similar pages -
GMP requirements for API - questions and answers
What are the new aspects of the Danish Medicines Act? What is an active pharmaceutical ingredient? W...www.dkma.dk/visUKLSArtikel.asp?artikelID=8127 - 32k - Cached - Similar pages -
FDA > CDRH > Medical Device Exemptions 510(k) and GMP Requirements
IMPORTANT NOTE: Only the class I devices with an asterisk (*) are also exempted from the GMP regulation, except for general requirements concerning records ...www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm - 17k - Cached - Similar pages -
Inspections - Good Manufacturing Practice
Good Manufacturing Practice (GMP) is defined as “That part of Quality Assurance ... co-ordination of advice on the interpretation of EU GMP requirements and ...www.emea.europa.eu/Inspections/GMPhome.html - 18k - Cached - Similar pages -
GMP - Good Manufacturing Practice
The annex has been revised in the light of new GMP requirements for .... The current “Basic Requirements” of the GMP guide will become Part I in the future. ...ec.europa.eu/enterprise/pharmaceuticals/pharmacos/gmp_doc.htm - 60k - Cached - Similar pages -
Complying with cGMP and GMP Requirements - Advanced Level
PTi's course on Complying with cGMP and GMP Requirements - Advanced Level.www.pti-international.com/cGMPGMPreqs/index.xml - 12k - Cached - Similar pages -
Friday, December 21, 2007
This is the fifth issue of LOGFILE – the newsletter published by Maas & Peither GMP Publishing.
This edition covers regulatory aspects.
1. What is a validated process?2. New Advisory Board Member Yukio Hiyama3. GMP Manual Contents update4. Excerpt: Checklist for API Audits5. GMP-Calendar 2008 - GMP day by day6. PDA/EMEA Joint Conference, February 18-21, 2008 7. Aphorism
Monday, December 17, 2007
Labeling and Consumer Protection
Proprietary Mixture Suppliers and Manufacturers
Questions and Answers
LABELING OF PROTEIN HYDROLYSATES
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Saturday, December 15, 2007
Site Master File
Preparing a Plant Master File
What is a Plant Master file?
A Plant Master File (sometimes referred to as a Site Master File) is a detailed description of the manufacturing facility, equipment and procedures used to produce the end-use product. It should contain sufficient information to give the reader a good idea of what the facility looks like, the type of manufacturing processes carried out in it and the type of quality assurance processes in place. It should satisfy the reader that the facility does comply with GMP requirements.
To meet APVMA requirements, the Plant Master File is expected to cover end-use product manufacture only. It does not need to cover raw materials manufacture.
The main information it should contain is described below. The important thing is to keep the document brief and relative to the needs of the type of product being made. Where possible, checklists, simple plans, outline drawings or schematic layouts should be used instead of narrative. Where a description of procedures is required, a copy of the relevant Standard Operating Procedures (SOPs) would meet APVMA requirements in most cases. As the main purpose of the Plant Master File is to demonstrate compliance with GMP, care should be taken to provide accurate and detailed information that relates to current practice in the facility.
The amount of information provided should be relevant to the type of product being made; for example, much more detailed information would be required for a facility making sterile products than for one making premixes or probiotics.
The document must be presented in English.
What should a Plant Master File contain?
The Plant Master File should firstly contain
1. A brief overview of the facility, including a description of its size and nature of construction, the number of staff, the amount and type of products made there, and the company's quality policy
In addition the document should provide brief descriptions of:
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GUIDANCE NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE MASTER FILE
[PDF]
Guidelines for drafting a Site Master File (SMF
File Format: PDF/Adobe Acrobat - View as HTMLA site master file is a document prepared by the manufacturer containing specific and factual GMP. information about the production and/or control of ...www.who.int/prequal/trainingresources/pq_pres/workshop_Vietnam_Jan2006/SiteMasterFile.pdf - Similar pages - Note this
Site master file (SMF) for drug products - Validation Master Plan
The drug product SITE MASTER FILE (SMF) is the site’s most important GMP document and provides a general overview of the site and its operations. ...www.gmp-online-consultancy.com/e/html/301_direct_order/310_validation-master-plan_detail.php?docIndex=64 - 24k - Cached - Similar pages - Note this
Site master file (SMF) for API - drug substances - Validation ...
A SITE MASTER FILE is prepared by the manufacturer and contains specific and factual GMP information about the production and/or control of API ...www.gmp-online-consultancy.com/e/html/301_direct_order/310_validation-master-plan_detail.php?docIndex=72 - 24k - Cached - Similar pages - Note this[ More results from www.gmp-online-consultancy.com ]
[PDF]
EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE MASTER ...
File Format: PDF/Adobe Acrobat - View as HTMLplanning and conducting GMP inspections. 4. SCOPE. These Explanatory Notes apply to the preparation of the Site Master File. Refer to ...www.validation-solutions.com/Guidance/PICS/PICS_PE%20008-2%20Site%20Master%20File.pdf - Similar pages - Note this
Site Master File - Wikipedia, the free encyclopedia
SMF: PIC/S explanatory notes A site master file is a document prepared by the manufacturer containing specific and factual GMP information about the ...en.wikipedia.org/wiki/Site_Master_File - 14k - Cached - Similar pages - Note this
[PDF]
Good Manufacturing Practise
File Format: PDF/Adobe Acrobat - View as HTMLSite Master File. • From Pharmaceutical Inspection. Convention, PIC. • Prepared by the manufacturer. • ”Specific and factual GMP information” ...doit.medfarm.uu.se/data/flvplayer/gmp/GMP_Dokumentation.pdf - Similar pages - Note this
[PDF]
SITE MASTER FILE
File Format: PDF/Adobe Acrobat - View as HTMLSITE MASTER FILE. (Adopted from PIC/S). REQUIREMENT. C.1 GENERAL INFORMATION .... C.2.3.2 Give details of training relative to GMP requirements ...www.nlfd.gov.tw/uploadfile/GMP/27_Site%20Master%20File.pdf - Similar pages - Note this
Thursday, December 13, 2007
Enzymes
Formulation of enzymes by formentation
Sources of enzymes
Biologically active enzymes may be extracted from any living organism. A very wide range of sources are used for commercial enzyme production from Actinoplanes to Zymomonas, from spinach to snake venom. Of the hundred or so enzymes being used industrially, over a half are from fungi and yeast and over a third are from bacteria with the remainder divided between animal (8%) and plant (4%) sources (Table 2.1). A very much larger number of enzymes find use in chemical analysis and clinical diagnosis. Non-microbial sources provide a larger proportion of these, at the present time. Microbes are preferred to plants and animals as sources of enzymes because:
they are generally cheaper to produce.
their enzyme contents are more predictable and controllable,
reliable supplies of raw material of constant composition are more easily arranged, and
plant and animal tissues contain more potentially harmful materials than microbes, including phenolic compounds (from plants), endogenous enzyme inhibitors and proteases.
Attempts are being made to overcome some of these difficulties by the use of animal and plant cell culture.
Specs for enzymes used in food
Monday, October 15, 2007
Maharashtra FDA
Drug Control Organizations worldwide
International Organizations and Foreign Government Agencies
International Organizations
Asia and the Pacific
Europe
Middle East
Africa
Americas
International Organizations
World Health Organization
Pan-American Health Organization
WHO Regional Office for Europe
WHO Regional Office for Africa
WHO Regional Office for the Eastern Mediterranean
WHO Regional Office for Southeast Asia
WHO Regional Office for the Western Pacific
Food and Agriculture Organization
Codex Alimentarius
World Trade Organization
Asia and the Pacific
Australia: Department of Health
Australia: Therapeutic Goods Administration
Food Standards Australia New Zealand
Australia: Agriculture, Fisheries and Forestry
Australia: Pesticides & Veterinary Medicines Authority
Bangladesh: Ministry of Food
Bangladesh: Ministry of Agriculture
Brunei: Ministry of Health
Brunei: Department of Agriculture
Brunei: Department of Fisheries
People´s Republic of China: General Administration of Quality Supervision, Inspection and Quarantine (in Chinese)
People's Republic of China: Ministry of Health (in Chinese)
People's Republic of China: State Drug Administration (in Chinese)
People's Republic of China: National Institute for the Control of Pharmaceutical and Biological Products (in Chinese)
People's Republic of China: Ministry of Agriculture (in Chinese)
Fiji: Ministry of Health
Fiji: Ministry of Agriculture, Sugar and Land Resettlement
Hong Kong: Department of Health
Hong Kong: Food and Environmental Hygiene Department
Hong Kong: Agriculture, Fisheries and Conservation Department
India: Ministry of Health and Family Welfare
India: Central Drug Standards Control Organisation
India: Ministry of Food and Consumer Affairs
India: Ministry of Food Processing Industries
India: Agricultural and Processed Food Products Export Development Authority
Indonesia: Ministry of Health
Indonesia: Ministry of Agriculture
Japan: Ministry of Health, Labour and Welfare
Japan: Pharmaceuticals and Medical Devices Evaluation Center
Japan: Ministry of Agriculture, Fisheries and Food
Korea: Food and Drug Administration
Korea: Ministry of Agriculture and Forestry
Malaysia: Ministry of Health
Malaysia: National Pharmaceutical Control Bureau
Malaysia: Ministry of Agriculture
New Zealand: Ministry of Health
New Zealand: Medicines and Medical Devices Safety Authority
New Zealand: Ministry of Agriculture
New Zealand: Food Safety Authority
New Zealand: Ministry of Fisheries
Papua New Guinea: Department of Health
Papua New Guinea: Department of Agriculture and Livestock
Philippines: Department of Health
Philippines: National Food Authority
Philippines: Department of Agriculture
Singapore: Ministry of Health
Singapore: Health Sciences Authority
Singapore: Ministry of Environment (food control)
Singapore: Agri-food and Veterinary Authority
Sri Lanka: Ministry of Health
Taiwan: Department of Health
Taiwan: National Laboratories of Foods and Drugs (in Chinese)
Thailand: Ministry of Public Health
Thailand: Food and Drug Administration
Thailand: Ministry of Agriculture and Co-operatives
Vietnam: Ministry of Agriculture and Rural Development
Europe
European Agency for the Evaluation of Medicinal Products
European Commission: DG Enterprise
European Commission/Enterprise and Industry/Cosmetics.
European Commission: DG Agriculture
European Commission: DG Fisheries
European Commission: DG Health and Consumer Protection
Andorra: Ministry of Health and Welfare (in Catalan)
Armenia: Ministry of Health
Armenia: Drug and Medical Technology Agency
Austria: Secretariat of Health (in German)
Austria: Ministry of Agriculture, Forestry, Environment and Water Management
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: Pharmaceutical Inspectorate
Belgium: Federal Agency for the Safety of the Food Chain
Bulgaria: Ministry of Health (in Bulgarian)
Bulgaria: Drug Agency
Croatia: Ministry of Health
Czech Republic: Ministry of Health (in Czech)
Czech Republic: State Institute for Drug Control
Czech Republic: Ministry of Agriculture
Czech Republic: Agriculture and Food Inspection Authority
Denmark: Ministry of Health
Denmark: Medicines Agency
Denmark: Ministry of Food, Agriculture and Fisheries
Denmark: Veterinary and Food Administration
Estonia: Ministry of Social Affairs
Estonia: State Agency of Medicines
Estonia: Ministry of Agriculture
Finland: Ministry of Social Affairs and Health
Finland: National Agency for Medicines
Finland: National Food Administration
Finland: Ministry of Agriculture and Forestry
France: Ministry of Health (in French)
France: Sanitary Safety of Health Products Agency (in French)
France: Agency for Food Safety
France: General Directorate of Competition, Consumption and Repression of Fraud (food control)(in French)
France: National Agency for Veterinary Medicinal Products
France: Agriculture, Fisheries and Food (in French)
Georgia: Ministry of Labor, Health and Social Protection
Georgia: Ministry of Agriculture and Products
Germany: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Germany: Robert Koch Institute (in German)
Germany: Paul Ehrlich Institute (in German)
Germany: Federal Institute for Risk Assessment
Germany: Ministry of Consumer Protection, Food and Agriculture
Greece: Ministry of Health and Welfare (in Greek)
Greece: National Organization for Medicines
Greece: Hellenic Food Authority
Greece: Hellenic Ministry of Agriculture
Hungary: Ministry of Health, Social and Family Affairs
Hungary: National Institute of Pharmacy
Hungary: Ministry of Agriculture
Iceland: Ministry of Health and Social Security
Iceland: Medicines Control Agency
Iceland: Environmental and Food Agency
Iceland: Ministry of Fisheries
Iceland: Ministry of Agriculture (in Icelandic)
Ireland: Department of Health and Children
Ireland: Medicines Board
Ireland: Food Safety Authority
Ireland: Agriculture and Food Development Authority
Italy: Ministry of Health (in Italian)
Italy: National Institute of Health
Italy: Ministry of Agricultural Policy (in Italian)
Latvia: State Agency of Medicines
Latvia: Ministry of Agriculture
Lithuania: Ministry of Health
Lithuania: State Medicines Control Agency
Lithuania: Ministry of Agriculture
Luxembourg: Ministry of Health (in French)
Luxembourg: Food Safety (in French)
Malta: Ministry of Health
Malta: Ministry of Agriculture and Fisheries
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: Medicines Evaluation Board
Netherlands: Ministry of Agriculture, Nature Management and Fisheries
Netherlands: Inspectorate for Health Protection and Veterinary Public Health
Norway: Ministry of Health and Social Affairs
Norway: Norwegian Board of Health
Norway: Food Control Authority (in Norwegian)
Norway: Norwegian Medicines Agency (in Norwegian)
Norway: Ministry of Agriculture
Norway: Ministry of Fisheries
Poland: Ministry of Health and Social Security (in Polish)
Poland: Drug Institute
Poland: Ministry of Agriculture and Rural Development
Portugal: Ministry of Health (in Portuguese)
Portugal: National Institute of Pharmacy and Medicines (in Portuguese)
Portugal: Ministry of Agriculture, Rural Development and Fisheries (in Portuguese)
Romania: Ministry of Health and the Family (in Romanian)
Romania: Ministry of Agriculture, Alimentation and Forests
Russian Federation: Ministry of Public Health (in Russian)
Russian Federation: Ministry of Agriculture and Food
San Marino: Ministry of Health and Social Security (in Italian)
Slovak Republic: Ministry of Health (in Slovak)
Slovak Republic: State Institute for Drug Control
Slovak Republic: Ministry of Agriculture
Slovak Republic: State Veterinary and Food Administration (in Slovak)
Slovenia: Ministry of Public Health (in Slovenian)
Slovenia: Institute of Public Health
Slovenia: Ministry of Agriculture, Forestry and Food
Spain: Ministry of Health and Consumption (in Spanish)
Spain: Spanish Drug Agency
Spain: Ministry of Agriculture, Fisheries and Food (in Spanish)
Sweden: Medical Products Agency
Sweden: National Board of Health and Welfare
Sweden: National Food Administration
Sweden: Ministry of Agriculture
Sweden: National Board of Fisheries (in Swedish)
Switzerland: Federal Office of Public Health
Switzerland: Agency for Therapeutic Products
Switzerland: Federal Veterinary Office
Switzerland: Federal Office for Agriculture
Turkey: Ministry of Health (in Turkish)
Turkey: Ministry of Agriculture and Rural Affairs
Ukraine: Ministry of Health
Ukraine: Ministry of Agroindustrial Complex
UK: Department of Health
UK: Health Protection Agency
UK: Medicines and Healthcare products Regulatory Agency
UK: National Institute for Biological Standards and Control
UK: Food Standards Agency
UK: Department for Environment, Food and Rural Affairs
UK: Veterinary Medicines Directorate
Middle East
Bahrain: Ministry of Health
Bahrain: Ministry of Housing and Agriculture
Israel: Ministry of Health
Israel: Ministry of Agriculture and Rural Development
Israel: Ministry of Industry and Trade
Jordan: Ministry of Health
Jordan: Ministry of Agriculture
Lebanon: Ministry of Health
Lebanon: Ministry of Agriculture
Palestinian Authority: Ministry of Health
Saudi Arabia: Ministry of Health
Saudi Arabia: Ministry of Agriculture and Water
United Arab Emirates: Ministry of Health
United Arab Emirates: Federal Department of Pharmacies
United Arab Emirates: Ministry of Agriculture and Fisheries
Yemen: Ministry of Public Health & Population
Africa
Benin: Ministry of Health (in French)
Benin: Ministry of Agriculture (in French)
Botswana: Ministry of Health
Botswana: Ministry of Agriculture
Egypt: Ministry of Agriculture and Land Reclamation
Ghana: Ministry of Health
Ghana: Ministry of Food and Agriculture
Kenya: Ministry of Health
Kenya: Ministry of Agriculture and Rural Development
Maldives: Ministry of Health
Maldives: Ministry of Fisheries, Agriculture and Marine Resources
Mauritius: Ministry of Health & Quality of Life
Mauritius: Ministry of Agriculture, Food Technology & Natural Resources
Mauritius: Ministry of Fisheries
Morocco: Ministry of Public Health (in French)
Morocco: Ministry of Agriculture, Rural Development, Water and Forests (in French)
Namibia: Ministry of Health and Social Services
Namibia: Ministry of Agriculture, Water and Rural Development
Namibia: Ministry of Fisheries and Marine Resources
Senegal: Ministry of Health, Hygiene and Prevention (in French)
Senegal: Ministry of Agriculture and Livestock (in French)
South Africa: Department of Health
South Africa: Department of Agriculture
Swaziland: Ministry of Health and Social Welfare
Swaziland: Ministry of Agriculture
Tanzania: Ministry of Health
Tanzania: Ministry of Agriculture & Food Security
Tunisia: Ministry of Public Health (in French)
Tunisia: Office of Pharmacy and Medicines (in French)
Tunisia: Ministry of Agriculture (in French)
Uganda: Ministry of Health
Zimbabwe: Ministry of Health and Child Welfare
Americas
Argentina: Ministry of Health (in Spanish)
Argentina: National Administration of Drugs, Foods and Medical Technology (in Spanish)
Argentina: Secretariat for Agriculture, Livestock, Fisheries and Food
Belize: Ministry of Health
Belize: Ministry of Agriculture, Fisheries and Cooperatives
Bolivia: Ministry of Health and Social Welfare (in Spanish)
Brazil: Ministry of Health (in Portuguese)
Brazil: National Health Surveillance Agency (in Portuguese)
Brazil: Fundacao Oswaldo Cruz
Brazil: Ministry of Agriculture (in Portuguese)
Canada: Health Products and Food Branch
Canada: Agriculture and Agri-Food
Canada: Food Inspection Agency
Chile: Health Ministry (in Spanish)
Chile: Institute of Public Health (in Spanish)
Chile: Ministry of Agriculture (in Spanish)
Chile: Undersecretariat of Fisheries (in Spanish)
Colombia: Ministry of Health (in Spanish)
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos (in Spanish)
Colombia: Ministry of Agriculture (in Spanish)
Costa Rica: Ministry of Health (in Spanish)
Costa Rica: Ministry of Agriculture and Livestock (in Spanish)
Dominican Republic: Ministry of Agriculture (in Spanish)
Ecuador: Ministry of Public Health (in Spanish)
Ecuador: Ministry of Foreign Trade, Industrialization, Fisheries and Competitiveness (in Spanish)
Ecuador: Ministry of Agriculture and Livestock
El Salvador: Ministry of Public Health and Social Assistance (in Spanish)
El Salvador: Ministry of Agriculture (in Spanish)
Guatemala: Ministry of Health (in Spanish)
Guatemala: Ministry of Agriculture, Livestock and Food (in Spanish)
Guyana: Ministry of Health
Guyana: Ministry of Agriculture
Guyana: National Bureau of Standards
Jamaica: Ministry of Health
Mexico: Ministry of Health (in Spanish)
Mexico: Federal Commission for Protection against Health Risks (in Spanish)
Mexico: Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food (in Spanish)
Netherlands Antilles: Department of Public Health and Environmental Protection
Nicaragua: Ministry of Health (in Spanish)
Nicaragua: Ministry of Agriculture and Forestry (in Spanish)
Panama: Ministry of Health (in Spanish)
Panama: Ministry of Agricultural Development (in Spanish)
Paraguay: Ministry of Agriculture and Livestock (in Spanish)
Peru: Ministry of Health (in Spanish)
Peru: General Directorate of Pharmaceuticals, Devices and Drugs (in Spanish)
Peru: Ministry of Agriculture (in Spanish)
St. Lucia: Ministry of Agriculture, Forestry, Fisheries and the Environment
Trinidad and Tobago: Ministry of Health
Trinidad and Tobago: Ministry of Agriculture, Land and Marine Resources
Trinidad & Tobago: Bureau of Standards
Uruguay: Ministry of Public Health (in Spanish)
Uruguay: Ministry of Livestock, Agriculture and Fisheries (in Spanish)
Venezuela: Ministry of Health and Social Development (in Spanish)
Venezuela: Ministry of Agriculture (in Spanish)
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Saturday, October 06, 2007
Air Handling Unit
Air Handling Units are often called AHU. The air-handling unit is box-like equipment with a fan and a cooling coil inside. Some units also contain air filters. The whole fan and motor assembly, comprising shaft, bearings, pulley, belting is usually put inside the AHU.
The basic function of the AHU is to suck air from the rooms, let it pass through chilled water cooling coils and then discharging the cooled air back to the rooms. Normally, letting it pass through panel or bag filters also filters the air. A certain amount of fresh air may be introduced at the suction duct so that air in the rooms may be gradually replaced. AHU's come in many sizes and shapes. Usually, the air conditioning designer will choose a particular AHU based on the air flow requirements and the cooling capacity. If humidity of the air has to be controlled, steam coils, or other heating coils may be installed. If the air has to be very cleaned, special HEPA filters have to be installed at the ducting outlets or at the AHU filter box. Moisture in the air is condensed out when it comes into contact with the chilled water coils. At the bottom of the AHU, a pipe is installed so that water that is collected can be drained out.
The fan and motor assembly is usually mounted on vibration dampers that absorb any vibrations generated. Removable panels are installed so that personnel can enter into the AHU for maintenance. Maintenance is mostly changing or washing of air filters, greasing of bearings, changing of belts, and general inspection and cleaning work.
Temperature Control
Controlling the flow of chilled water through the cooling coils alters the temperature of the discharged air into the rooms. Control valves are used to throttle chilled water through the chilled water coils. A simple temperature control system uses thermostats to control on-off solenoid valves. A better control system uses temperature sensors, controllers, and motorized control valve. More complicating systems may have motor speed control for the fan.
Humidity Control
Some critical processes may require that the humidity of the air-conditioned space be controlled. During the normal cooling process, as the air becomes cooler, the relative humidity of the air tends to increase. If the relative humidity have to be brought down, the air have to be heated by steam coils or other means. Steam coils, if installed will have their own controls. A typical control system has a temperature sensor, controller, and control valve. Usually, humans monitor the relative humidity, and the steam controller settings are adjusted accordingly.
Psychrometry
Persons who want to control temperature and humidity of the air in the air conditioning system should have an understanding of psychrometry. They make use of psychrometric charts to determine various parameters of the air at any condition. For example, by knowing two parameters, you can look up the chart to find the other values. The values found in a typical psychrometric chart are:
Dry Bulb Temperature
Wet Bulb Temperature
Dewpoint Temperature
Relative Humidity
Humidity Ratio
Other parameters that can be found from the psychrometric chart are:
Enthalpy
Sensible Heat Ratio
Vapor Pressure
Specific Volume
more
ISO 14644-1
CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1. CLASSIFICATION OF AIR CLEANLINESS
ISO 14644-2
CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR TESTING AND MONITORING TO PROVE CONTINUED COMPLIANCE WITH ISO 14644-1
Tuesday, October 02, 2007
Law Strengthens FDA
Topics on this Page
Introduction
What is FDA Doing
News Updates
Law
Introduction
On September 27, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007, with (from left to right) HHS Secretary Michael Leavitt, FDA Commissioner Andrew von Eschenbach, and Rep. Joe Barton of Texas in the Oval Office. This new law represents a very significant addition to FDA authority. Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded. These programs will ensure that FDA staff have the additional resources needed to conduct the complex and comprehensive reviews necessary to new drugs and devices.
Two other important laws were reauthorized: the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Both of these are designed to encourage more research into, and more development of, treatments for children.
Overall, this new law will provide significant benefits for those who develop medical products, and for those who use them.
What is FDA Doing?
Renewed Legislation Improves Safety of FDA-Regulated Products
News Updates
New Law Ensures Access to Medical Treatments and Information (HHS press release, September 27, 2007)
Statement on Congressional passage of FDAAA (September 20, 2007)
Law
Food and Drug Administration Amendments Act of 2007 (pdf, 384 KB)
more
New Law Ensures Access to Medical Treatments and Information
Legislation Reauthorizes Key User Fee Programs
Following the President’s signature of the Food and Drug Administration (FDA) Amendments Act, HHS Secretary Mike Leavitt praised the bill as an important step forward in ensuring the safety of drugs and medical devices.
“Facilitating safe and timely access to effective medicines is a critical mission of the federal government,” Secretary Leavitt said. “These laws will greatly benefit the public health of our nation, and keep us on a path to ensuring Americans have access to the best medications and devices available to lead longer and healthier lives.”
Commissioner of the Food and Drug Administration Dr. Andrew von Eschenbach said, “The act continues essential and successful programs that will enhance FDA’s ability to more efficiently and effectively regulate drugs, biological products, and medical devices. It will provide enormous benefit to the public health by allowing FDA to continue to deliver safe and effective medical products to Americans every day.”
The measure extends the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, which have yielded vital information about the use of drugs and biological products to treat children.
In addition, the legislation amends and establishes many other programs and activities related to medical product safety. It also establishes a nonprofit corporation, the Reagan-Udall Foundation, to advance the mission of FDA.