Anti counterfeit products detection and analysis.Use new technique this proposal was use for training Dubai mincipility operation staff on 31_05-2022 to 01_06_2022
This document summarizes the key differences between regulations for cosmetics and drugs in the United States. It notes that drugs require FDA approval before being sold, while cosmetics do not. For cosmetics, the FDA can only regulate products after they are on the market. The document also discusses Good Manufacturing Practice requirements, registration and labeling regulations, and how safety and efficacy must be established for drugs but not for cosmetics. It provides an overview of the Cosmetic Ingredient Review process and actions the FDA can take against adulterated or misbranded cosmetics.
An international panel comprised of members of AQSIQ (China), INMETRO (Brazil), Health Canada and CPSC (U.S.) used this presentation to discuss the regulatory structure and suggestions for businesses.
The document discusses alcohol and drug testing in the construction industry. It provides statistics on alcohol-related deaths and injuries in Western Australia. It promotes an alcohol and drug testing policy and program from Alcolizer Technology, discussing the benefits of testing, different testing methods, developing a policy, and the rights and obligations of employers and employees. Alcolizer Technology presents itself as a leader in alcohol and drug testing solutions, offering testing equipment, programs, training, and support.
Bilcare Technologies provides anti-counterfeiting and supply chain security solutions to help combat the global problem of counterfeit drugs. Their unique nonClonableID technology applies randomly generated fingerprint labels to pharmaceutical products to enable authentication throughout the supply chain. Bilcare's comprehensive approach utilizes secure process control, authentication, and track-and-trace to monitor drug production and distribution, identify potential counterfeit entry points, and promote an ecosystem that deters counterfeiting. This secures brands and revenues while ensuring patients receive genuine medication.
GMP regulations provide minimum standards for pharmaceutical manufacturing to ensure consistent high quality, safety, and efficacy of medicines. Key aspects of GMP include having documented procedures, validated processes, qualified facilities and equipment, trained personnel, cleaning and maintenance programs, quality control testing, and compliance auditing. Following GMP helps manufacturers produce pharmaceuticals that meet marketing authorizations and protects public health.
Common ways to avoid frequent gmp errorsKiran Kota
Presentation on avoiding the GMP errors with some controls and actions which are mentioned in the same which may help the industry on current trends of regulatory inspections.
Quality assurance and validation processes are essential for ensuring safe and effective pharmaceutical products. Key aspects of quality management include adhering to ISO, WHO, and other certification standards. Quality assurance focuses on preventing defects during development, while quality control identifies defects after production. Laboratories must follow strict safety protocols like prohibiting food/drinks, regularly disinfecting surfaces, and properly disposing of contaminated materials. Organizations should implement quality planning, control, assurance, and improvement systems.
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
This document summarizes the key differences between regulations for cosmetics and drugs in the United States. It notes that drugs require FDA approval before being sold, while cosmetics do not. For cosmetics, the FDA can only regulate products after they are on the market. The document also discusses Good Manufacturing Practice requirements, registration and labeling regulations, and how safety and efficacy must be established for drugs but not for cosmetics. It provides an overview of the Cosmetic Ingredient Review process and actions the FDA can take against adulterated or misbranded cosmetics.
An international panel comprised of members of AQSIQ (China), INMETRO (Brazil), Health Canada and CPSC (U.S.) used this presentation to discuss the regulatory structure and suggestions for businesses.
The document discusses alcohol and drug testing in the construction industry. It provides statistics on alcohol-related deaths and injuries in Western Australia. It promotes an alcohol and drug testing policy and program from Alcolizer Technology, discussing the benefits of testing, different testing methods, developing a policy, and the rights and obligations of employers and employees. Alcolizer Technology presents itself as a leader in alcohol and drug testing solutions, offering testing equipment, programs, training, and support.
Bilcare Technologies provides anti-counterfeiting and supply chain security solutions to help combat the global problem of counterfeit drugs. Their unique nonClonableID technology applies randomly generated fingerprint labels to pharmaceutical products to enable authentication throughout the supply chain. Bilcare's comprehensive approach utilizes secure process control, authentication, and track-and-trace to monitor drug production and distribution, identify potential counterfeit entry points, and promote an ecosystem that deters counterfeiting. This secures brands and revenues while ensuring patients receive genuine medication.
GMP regulations provide minimum standards for pharmaceutical manufacturing to ensure consistent high quality, safety, and efficacy of medicines. Key aspects of GMP include having documented procedures, validated processes, qualified facilities and equipment, trained personnel, cleaning and maintenance programs, quality control testing, and compliance auditing. Following GMP helps manufacturers produce pharmaceuticals that meet marketing authorizations and protects public health.
Common ways to avoid frequent gmp errorsKiran Kota
Presentation on avoiding the GMP errors with some controls and actions which are mentioned in the same which may help the industry on current trends of regulatory inspections.
Quality assurance and validation processes are essential for ensuring safe and effective pharmaceutical products. Key aspects of quality management include adhering to ISO, WHO, and other certification standards. Quality assurance focuses on preventing defects during development, while quality control identifies defects after production. Laboratories must follow strict safety protocols like prohibiting food/drinks, regularly disinfecting surfaces, and properly disposing of contaminated materials. Organizations should implement quality planning, control, assurance, and improvement systems.
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
Testing a Food or Beverage product is conducted for estimating the
presence of microbial contamination, change in the pH, sensory
evaluation, Shelf Life and the quality of the water used in the preparation.
This document proposes a product called ELLE18 Wonder Girl, which is designed to detect drugs in drinks and ensure women's safety. The product would change color if it comes into contact with date rape drugs like Rohypnol, GHB, or ketamine. It aims to alert women and prevent drug-facilitated sexual assaults, which affect many college students. The document outlines market research showing the need for such a product and lays out plans for concept development, initial testing, targeting metro cities with bars and clubs, promotion through celebrities and NGOs, and commercialization at a price of 350-450 rupees. It concludes that the product could help protect women and address an important social issue.
Devices Sponsor Information Day: 5 - Post-market - Advertising therapeutic go...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Ambiance Ventures provides international distribution services for vaccines, biologics, specialty pharma, generics, hospital supplies and diagnostics. They have capabilities in both government and private markets globally. Their services include regulatory assistance, logistics, order processing, accounts receivables, compliance, sales, and more. They have offices and affiliates around the world to facilitate global distribution.
This document discusses Ambiance Ventures' capabilities in international distribution of vaccines, biologics, specialty pharma, generics, hospital supplies and diagnostics. It outlines their services such as regulatory support, logistics, order processing, accounts receivables, government and private sales, repackaging, delivery and more. It also provides details on their operations in India, affiliates in other countries, and ability to source products from manufacturers to consolidate and distribute globally.
Bilcare Technologies provides anti-counterfeiting solutions using its nonClonableID technology. It applies unique material fingerprints to products and packaging that cannot be copied and enables authentication of products as they move through the supply chain. The nonClonableID labels allow products to be verified and traced from manufacturing to point of sale to prevent counterfeiting and diversion. It provides high security and visibility across international supply chains for fashion and luxury brands.
2nd Pharmaceutical Anti Counterfeiting Americas (2011) PpPiyush Patel
This document provides information about the "2nd Pharmaceutical Anti-counterfeiting Americas" conference taking place on November 14-15, 2011 in Boston, USA. The conference will discuss combating counterfeit medicines and feature speakers from pharmaceutical companies and regulatory agencies. Attendees will learn about US policy updates, technologies for tracking pharmaceuticals, and best practices for supply chain integrity. Posters can be submitted by academic institutions, pharmaceutical companies, and service providers to share research results. The conference is aimed at professionals working in pharmaceutical supply chain security, anti-counterfeiting, brand protection, and related fields.
A trademark is a sign capable of distinguishing the goods or services of one enterprise from those of other enterprises. Trademarks are protected by intellectual property rights.
C gmp’s for pharmaceutical manufacturingabhikanavaje
Current Good Manufacturing Practices (cGMP) are regulations aimed at ensuring consistent quality in manufacturing processes. cGMP guidelines have been established by various regulatory bodies worldwide including the US FDA, WHO, and India. Adhering to cGMP helps reduce errors and contamination, ensures safety and reproducibility, and prevents mislabeling. Key cGMP requirements include establishing quality systems, personnel training, facility and equipment validation, material handling procedures, production and packaging processes, quality testing, and record keeping. Proper documentation, process validation, and compliance with standard operating procedures are essential for meeting cGMP standards.
Ambiance Ventures provides international distribution services for vaccines, biologics, specialty pharma, generics, hospital supplies and diagnostics. They have capabilities in both government and private markets globally. Their services include regulatory assistance, logistics, order processing, accounts receivables, compliance, private market support, pharmacovigilance, and operations in India for product registration, warehousing and distribution. They specialize in developing business strategies and marketing clients' products internationally using their network of agents and expertise in customs, shipping and regulatory requirements.
Ambiance Ventures provides international distribution services such as regulatory assistance, logistics, customs clearance, and sales for vaccines, biologics, generics, and medical supplies. They have offices and affiliates around the world that can source products from manufacturers to consolidate and ship globally. Their business model focuses on bulk buying and freight to offer competitive pricing. Clients can utilize Ambiance Ventures' infrastructure for international market access and distribution.
Ambiance Ventures provides international distribution services for vaccines, biologics, specialty pharma, generics, hospital supplies and diagnostics. They have capabilities in government and private markets globally. Their services include regulatory assistance, logistics, order processing, accounts receivables, compliance, and more. They are qualified distributors in various countries and comply with all necessary paperwork and regulations for government tenders.
Ambiance Ventures provides international distribution services including regulatory assistance, logistics, warehousing, and sales for vaccines, biologics, specialty pharmaceuticals, generics, hospital supplies, and diagnostics in global markets. They have capabilities in both government and private markets. Their services include product registration, customs clearance, order processing, accounts receivables, and more. They are qualified as preferred distributors in various countries and comply with all regulatory and legal requirements.
Global Pharmas is a life sciences advisory firm serving the pharmaceutical and biotech industries. They deliver solutions for organizational effectiveness, branding, business development, and market entry. Their team has extensive experience in commercial roles. Global Pharmas represents clients seeking licensing deals for late-stage or commercialized products with differentiation. They identify opportunities, approach owners, and facilitate deals in key therapeutic areas like pain, respiratory, and dermatology.
The document discusses ISO 10993, which provides guidance for conducting biological evaluations of medical devices to assess safety. It consists of multiple parts that cover areas like test methods, reference materials, animal welfare, characterization of materials, and degradation products. The strategy is to use a risk management framework per ISO 10993-1 to determine what testing is necessary based on understanding the device, materials, and risks, drawing on existing knowledge where possible. Only gaps in knowledge need be filled through appropriate testing to adequately evaluate biological safety.
This document provides an overview of key sections of USP Chapter <797> on pharmaceutical compounding of sterile products. It discusses requirements for personnel training and certification, environmental quality controls, and risk classifications for compounded sterile preparations. Proper cleaning and garbing of personnel, accuracy verification of compounded products, and sterilization methods are also summarized. The goal of Chapter <797> is to prevent patient harm from microbial contamination or incorrect ingredients in compounded sterile products.
Chemir Analytical Services provides analytical testing services for various industries. It has over 50 years of experience solving problems for nearly 7,000 clients worldwide through techniques like deformulation, materials identification, failure analysis, and litigation support. The document outlines Chemir's capabilities and quality standards for analytical testing and highlights how it has assisted clients in industries like food and beverage, pharmaceuticals, plastics, and medical devices.
Office of Drug & Alcohol Policy & Compliance - My CopyRobert Gordon
The document provides information about DOT drug and alcohol testing requirements for safety-sensitive employees. It explains that employees in industries regulated by DOT such as aviation, transit, and commercial driving are subject to testing. Employees can be tested for drugs and alcohol in pre-employment, post-accident, random, reasonable suspicion, return-to-duty, and follow-up situations. The testing process involves collection of urine specimens, laboratory testing, and review by a medical review officer. Prescription drugs may be allowed if certain conditions are met, and use of illegal drugs is strictly prohibited.
The National Association of Manufacturers (NAM) advocates on behalf of US manufacturers. It represents over 11,000 member companies of all sizes, accounting for 85% of US manufacturing output. The NAM works to shape legislation and regulations in a way that promotes US economic growth and manufacturing competitiveness. Regulatory compliance costs American manufacturers $162 billion annually, disproportionately impacting small manufacturers. The Consumer Product Safety Improvement Act (CPSIA) strengthened safety standards for children's products and imposed new testing, certification, and labeling requirements that increased costs for manufacturers.
1) Between 2005-2014, there were 586 food recalls in Australia, averaging 59 recalls per year. In 2014, the top 3 reasons for recalls were undeclared allergens, microbial contamination, and foreign matter.
2) Undeclared allergens made up 21% of recalls, with peanuts, dairy, and wheat being the top undeclared allergens. Processed foods and confectionary were the most common culprit product categories.
3) Proper food labeling is important to inform consumers about allergens, ingredients, storage, and other details. Legislation in Australia and other countries mandate clear labeling of certain allergens and substances.
The Power of Community Newsletters: A Case Study from Wolverton and Greenleys...Scribe
YOU WILL DISCOVER:
The engaging history and evolution of Wolverton and Greenleys Town Council's newsletter
Strategies for producing a successful community newsletter and generating income through advertising
The decision-making process behind moving newsletter design from in-house to outsourcing and its impacts
Dive into the success story of Wolverton and Greenleys Town Council's newsletter in this insightful webinar. Hear from Mandy Shipp and Jemma English about the newsletter's journey from its inception to becoming a vital part of their community's communication, including its history, production process, and revenue generation through advertising. Discover the reasons behind outsourcing its design and the benefits this brought. Ideal for anyone involved in community engagement or interested in starting their own newsletter.
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Testing a Food or Beverage product is conducted for estimating the
presence of microbial contamination, change in the pH, sensory
evaluation, Shelf Life and the quality of the water used in the preparation.
This document proposes a product called ELLE18 Wonder Girl, which is designed to detect drugs in drinks and ensure women's safety. The product would change color if it comes into contact with date rape drugs like Rohypnol, GHB, or ketamine. It aims to alert women and prevent drug-facilitated sexual assaults, which affect many college students. The document outlines market research showing the need for such a product and lays out plans for concept development, initial testing, targeting metro cities with bars and clubs, promotion through celebrities and NGOs, and commercialization at a price of 350-450 rupees. It concludes that the product could help protect women and address an important social issue.
Devices Sponsor Information Day: 5 - Post-market - Advertising therapeutic go...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Ambiance Ventures provides international distribution services for vaccines, biologics, specialty pharma, generics, hospital supplies and diagnostics. They have capabilities in both government and private markets globally. Their services include regulatory assistance, logistics, order processing, accounts receivables, compliance, sales, and more. They have offices and affiliates around the world to facilitate global distribution.
This document discusses Ambiance Ventures' capabilities in international distribution of vaccines, biologics, specialty pharma, generics, hospital supplies and diagnostics. It outlines their services such as regulatory support, logistics, order processing, accounts receivables, government and private sales, repackaging, delivery and more. It also provides details on their operations in India, affiliates in other countries, and ability to source products from manufacturers to consolidate and distribute globally.
Bilcare Technologies provides anti-counterfeiting solutions using its nonClonableID technology. It applies unique material fingerprints to products and packaging that cannot be copied and enables authentication of products as they move through the supply chain. The nonClonableID labels allow products to be verified and traced from manufacturing to point of sale to prevent counterfeiting and diversion. It provides high security and visibility across international supply chains for fashion and luxury brands.
2nd Pharmaceutical Anti Counterfeiting Americas (2011) PpPiyush Patel
This document provides information about the "2nd Pharmaceutical Anti-counterfeiting Americas" conference taking place on November 14-15, 2011 in Boston, USA. The conference will discuss combating counterfeit medicines and feature speakers from pharmaceutical companies and regulatory agencies. Attendees will learn about US policy updates, technologies for tracking pharmaceuticals, and best practices for supply chain integrity. Posters can be submitted by academic institutions, pharmaceutical companies, and service providers to share research results. The conference is aimed at professionals working in pharmaceutical supply chain security, anti-counterfeiting, brand protection, and related fields.
A trademark is a sign capable of distinguishing the goods or services of one enterprise from those of other enterprises. Trademarks are protected by intellectual property rights.
C gmp’s for pharmaceutical manufacturingabhikanavaje
Current Good Manufacturing Practices (cGMP) are regulations aimed at ensuring consistent quality in manufacturing processes. cGMP guidelines have been established by various regulatory bodies worldwide including the US FDA, WHO, and India. Adhering to cGMP helps reduce errors and contamination, ensures safety and reproducibility, and prevents mislabeling. Key cGMP requirements include establishing quality systems, personnel training, facility and equipment validation, material handling procedures, production and packaging processes, quality testing, and record keeping. Proper documentation, process validation, and compliance with standard operating procedures are essential for meeting cGMP standards.
Ambiance Ventures provides international distribution services for vaccines, biologics, specialty pharma, generics, hospital supplies and diagnostics. They have capabilities in both government and private markets globally. Their services include regulatory assistance, logistics, order processing, accounts receivables, compliance, private market support, pharmacovigilance, and operations in India for product registration, warehousing and distribution. They specialize in developing business strategies and marketing clients' products internationally using their network of agents and expertise in customs, shipping and regulatory requirements.
Ambiance Ventures provides international distribution services such as regulatory assistance, logistics, customs clearance, and sales for vaccines, biologics, generics, and medical supplies. They have offices and affiliates around the world that can source products from manufacturers to consolidate and ship globally. Their business model focuses on bulk buying and freight to offer competitive pricing. Clients can utilize Ambiance Ventures' infrastructure for international market access and distribution.
Ambiance Ventures provides international distribution services for vaccines, biologics, specialty pharma, generics, hospital supplies and diagnostics. They have capabilities in government and private markets globally. Their services include regulatory assistance, logistics, order processing, accounts receivables, compliance, and more. They are qualified distributors in various countries and comply with all necessary paperwork and regulations for government tenders.
Ambiance Ventures provides international distribution services including regulatory assistance, logistics, warehousing, and sales for vaccines, biologics, specialty pharmaceuticals, generics, hospital supplies, and diagnostics in global markets. They have capabilities in both government and private markets. Their services include product registration, customs clearance, order processing, accounts receivables, and more. They are qualified as preferred distributors in various countries and comply with all regulatory and legal requirements.
Global Pharmas is a life sciences advisory firm serving the pharmaceutical and biotech industries. They deliver solutions for organizational effectiveness, branding, business development, and market entry. Their team has extensive experience in commercial roles. Global Pharmas represents clients seeking licensing deals for late-stage or commercialized products with differentiation. They identify opportunities, approach owners, and facilitate deals in key therapeutic areas like pain, respiratory, and dermatology.
The document discusses ISO 10993, which provides guidance for conducting biological evaluations of medical devices to assess safety. It consists of multiple parts that cover areas like test methods, reference materials, animal welfare, characterization of materials, and degradation products. The strategy is to use a risk management framework per ISO 10993-1 to determine what testing is necessary based on understanding the device, materials, and risks, drawing on existing knowledge where possible. Only gaps in knowledge need be filled through appropriate testing to adequately evaluate biological safety.
This document provides an overview of key sections of USP Chapter <797> on pharmaceutical compounding of sterile products. It discusses requirements for personnel training and certification, environmental quality controls, and risk classifications for compounded sterile preparations. Proper cleaning and garbing of personnel, accuracy verification of compounded products, and sterilization methods are also summarized. The goal of Chapter <797> is to prevent patient harm from microbial contamination or incorrect ingredients in compounded sterile products.
Chemir Analytical Services provides analytical testing services for various industries. It has over 50 years of experience solving problems for nearly 7,000 clients worldwide through techniques like deformulation, materials identification, failure analysis, and litigation support. The document outlines Chemir's capabilities and quality standards for analytical testing and highlights how it has assisted clients in industries like food and beverage, pharmaceuticals, plastics, and medical devices.
Office of Drug & Alcohol Policy & Compliance - My CopyRobert Gordon
The document provides information about DOT drug and alcohol testing requirements for safety-sensitive employees. It explains that employees in industries regulated by DOT such as aviation, transit, and commercial driving are subject to testing. Employees can be tested for drugs and alcohol in pre-employment, post-accident, random, reasonable suspicion, return-to-duty, and follow-up situations. The testing process involves collection of urine specimens, laboratory testing, and review by a medical review officer. Prescription drugs may be allowed if certain conditions are met, and use of illegal drugs is strictly prohibited.
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1) Between 2005-2014, there were 586 food recalls in Australia, averaging 59 recalls per year. In 2014, the top 3 reasons for recalls were undeclared allergens, microbial contamination, and foreign matter.
2) Undeclared allergens made up 21% of recalls, with peanuts, dairy, and wheat being the top undeclared allergens. Processed foods and confectionary were the most common culprit product categories.
3) Proper food labeling is important to inform consumers about allergens, ingredients, storage, and other details. Legislation in Australia and other countries mandate clear labeling of certain allergens and substances.
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The Power of Community Newsletters: A Case Study from Wolverton and Greenleys...Scribe
YOU WILL DISCOVER:
The engaging history and evolution of Wolverton and Greenleys Town Council's newsletter
Strategies for producing a successful community newsletter and generating income through advertising
The decision-making process behind moving newsletter design from in-house to outsourcing and its impacts
Dive into the success story of Wolverton and Greenleys Town Council's newsletter in this insightful webinar. Hear from Mandy Shipp and Jemma English about the newsletter's journey from its inception to becoming a vital part of their community's communication, including its history, production process, and revenue generation through advertising. Discover the reasons behind outsourcing its design and the benefits this brought. Ideal for anyone involved in community engagement or interested in starting their own newsletter.
Presentation by Rebecca Sachs and Joshua Varcie, analysts in CBO’s Health Analysis Division, at the 13th Annual Conference of the American Society of Health Economists.
Causes Supporting Charity for Elderly PeopleSERUDS INDIA
Around 52% of the elder populations in India are living in poverty and poor health problems. In this technological world, they became very backward without having any knowledge about technology. So they’re dependent on working hard for their daily earnings, they’re physically very weak. Thus charity organizations are made to help and raise them and also to give them hope to live.
Donate Us:
https://serudsindia.org/supporting-charity-for-elderly-people-india/
#oldagehome, #donateforeldersinkurnool, #donateforelders, #donationforelders, #donateforoldpeople, #donationforoldpeople, #sponsorforelders, #sponsorforoldpeople, #donationforcharity, #charity, #seruds, #kurnool, #donateforoldagehome, #oldagehomedonation
FT author
Amanda Chu
US Energy Reporter
PREMIUM
June 20 2024
Good morning and welcome back to Energy Source, coming to you from New York, where the city swelters in its first heatwave of the season.
Nearly 80 million people were under alerts in the US north-east and midwest yesterday as temperatures in some municipalities reached record highs in a test to the country’s rickety power grid.
In other news, the Financial Times has a new Big Read this morning on Russia’s grip on nuclear power. Despite sanctions on its economy, the Kremlin continues to be an unrivalled exporter of nuclear power plants, building more than half of all reactors under construction globally. Read how Moscow is using these projects to wield global influence.
Today’s Energy Source dives into the latest Statistical Review of World Energy, the industry’s annual stocktake of global energy consumption. The report was published for more than 70 years by BP before it was passed over to the Energy Institute last year. The oil major remains a contributor.
Data Drill looks at a new analysis from the World Bank showing gas flaring is at a four-year high.
Thanks for reading,
Amanda
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New report offers sobering view of the energy transition
Every year the Statistical Review of World Energy offers a behemoth of data on the state of the global energy market. This year’s findings highlight the world’s insatiable demand for energy and the need to speed up the pace of decarbonisation.
Here are our four main takeaways from this year’s report:
Fossil fuel consumption — and emissions — are at record highs
Countries burnt record amounts of oil and coal last year, sending global fossil fuel consumption and emissions to all-time highs, the Energy Institute reported. Oil demand grew 2.6 per cent, surpassing 100mn barrels per day for the first time.
Meanwhile, the share of fossil fuels in the energy mix declined slightly by half a percentage point, but still made up more than 81 per cent of consumption.
2. Trainer Profile:
• Dr:Khalid Suliman Osman
• K.adam@moi.gov.ae
• - Senior Forensic Technician (UAE Ministry of interior ).
• - Master’s pharmacy (Drug Manufacturing & Quality
Control) & MBA.
• - Crime Counterfeiting products Analysis- Expert.
• - American Board of pharmacy Specialties licence –
USA.
• UAE Ministry of Health Pharmacist License.
• 25 Treaning ( NATIONAL INSTETUTE OF JUSTICE)-USA
• - Cooperation with Sharjah International Airport
Authority in detection of counterfeited products.
• Expo 2020 Dubai -Site Operation Manager,
• - Other information’s and certifications of the tutor
are supported in the attached CV.
FALCON AMBITIOUS FOR TRAINING & CONSULTANCY
3. Course Outlines
• Introduction about the importance of counterfeit
product detection & prevention.
• Explain the various consequences of products
counterfeit.
• Relevant terminologies regarding products counterfeit.
• Types of products counterfeiting.
• Classification of falsified.
• List of possible counterfeited products.
• Physical detection of the counterfeited consumer
products overview.
• Physical techniques used for counterfeit detection
during field inspection.
• Filed inspection schemes for product counterfeit
detection.
• Gap analysis
FALCON AMBITIOUS FOR TRAINING & CONSULTANCY
5. Counterfeit Definition
• Counterfeiting is the manufacture, import,
export, distribution, and sale of consumer
goods that are not genuine but are
designed and branded to look identical to
the authentic products in order to deceive
consumers into believing that they are
authentic.
Keyword -Fakeness
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
6. How to identify fakes and other IPR
infringing goods
• Examine the quality of the product. ...
• Be wary of unusually low prices. ...
• Inspect the packaging carefully. ...
• Check if logos and trademarks are displayed
correctly
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
12. FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
The term "counterfeit
In General: counterfeit is Intellectual Property (IP)
Theft? Counterfeiting is a crime involving the theft
of someone’s trademark.
Pharmaceutical Counterfeiting (WHO & FDA):
"counterfeit Drugs " means a “a Drug in which is
deliberately and fraudulently mislabeled with
respect to identity in the container or labeling or
packaging without authorization, in the
trademark, trade name, or other identifying mark,
of a drug manufacturer, processor and distributor
other than the person who in fact manufactured.
13. GENERAL DISCUSSION
• Product profile
• Weight variation
• GLB (QC)
• IPR
• International Counterfeit Acts
• Crime Counterfeit evidence products
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
14. FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
There are two types of fake medicines: products that
made like genuine medicines, and products that make
false claims about their ingredients.
A counterfeit medicine could have:
• No active ingredient
• Substandard ingredients
• Undeclared ingredients
• Illegal or dangerous ingredients
• Incorrect dosage (too much, too little or variation in
dose across tablets)
• Contaminants from unhygienic manufacture.
What is a counterfeit medicine?
17. FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
Types of Products Counterfeit
• Foods & Beverage: (International Adulteration
of foods with cheapest ingredients for Economic
gain), (Narcotic Bread eg- Poppy seed),
Presenter Tests Positive for Opiates after eating it.
• Pharmaceuticals: (Packaging- Ingredients-
Storage condition Cosmetics & Preservatives)
Example: Pfizer® (Viagra- Plavix- zyprexa).
• Toys: Illicit toys mislead consumers
include counterfeit products, which mislead
consumers to believe they are genuine products.
18. FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
Types of Products Counterfeit
• Apparel &Accessories: Examples: (Sport Items-
Rolex Watches).
• Cigarettes & Wine: (Special logo)
• Media: (Computers- DVDs- Antivirus etc).
• Electronics: Mobiles- and etc.
• Automotive: Examples: Scooters-Speare parts.
• Chemical Pesticides:
• Others: Sun glasses- Handbags- Watches, etc
20. Classification of Falsified Products
One way to classify falsified Products is to assign
categories based on the sophistication of the fake. This is
an example of such categorization.
•
Category 1: Completely fraudulent products with
unknown contents and therapeutic effects significantly
different from the genuine Products (drugs).
•
Look somewhat similar to the Products
:
2
Category
(drugs) being imitated, but the Products (drugs)
composition is not known.
•
Look very similar or identical to the
:
3
Category
but contain an entirely different
genuine product
Products (drugs).
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
21. Classification of Falsified Products
•
Category 4: Look very similar or identical to the
contain an alternative Products
actual product but
providing similar
(drugs) or synthetic analogue
to that of the authentic product;
therapeutic value
intended to create repeat business.
•
Visually identical, highly
:
5
Category
or synthetic analogues with
sophisticated copies
some therapeutic value that cannot be detected
using most field and laboratory methods.
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
23. Overview of Detection, Screening,
and Analytical Techniques
The main categories of techniques for consumer
products analysis can be broken down as follows:
•
visual inspection of product and packaging;
•
such as
tests for physical properties
disintegration, reflectance spectroscopy, and
refractive index;
•
chemical tests including colorimetry and
dissolution; chromatography; spectroscopic
techniques; and mass spectrometry.
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
24. Overview of Detection, Screening,
and Analytical Techniques
Within each of these categories, some
use in the field
technologies are appropriate for
with minimal training, while others require
equipment and a high level of
sophisticated lab
technical expertise.
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
40. Visual Inspection and Package
Technologies
• An expert can identify some consumer product
quality problems by sight. Therefore, visual
inspection of a product and its packaging by
someone who knows the properties of the
authentic product or is able to compare the
sample to the authentic product is the standard
first step in any Products (drugs) quality
analysis
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CONSULTANCY
41. Visual Inspection and Package
Technologies
• These visual inspections provide qualitative
data about products identities. Differences
from the authentic materials in colour, size,
shape, products quality, and packaging indicate
a possible falsified or substandard product.
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CONSULTANCY
42. Visual Inspection and Package
Technologies
• These differences range from subtle to
obvious. An educated consumer could
probably identify a very-poor-quality fake,
such as a pill of entirely the wrong color or
shape, if they knew some properties of the
authentic product, but even experts struggle to
recognize more subtle inconsistencies.
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CONSULTANCY
43. Visual Inspection and Package
Technologies
• The Global Pharma Health Fund's Minilab
toolkit promotes visual inspection as the first
step to identifying falsified and substandard
Products (drugs)s but admits that this is
challenging even for experts. In recent years,
criminals have produced very accurate
reproductions of legitimate packaging. And,
poor-quality products can sometimes be
hidden in legitimate packaging .
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CONSULTANCY
44. Visual Inspection and Package
Technologies
• Visual inspection of a product can yield useful
information, however. Some substandard Products
(drugs)s are of visibly low quality. Tablets that are
cracked or falling apart are products of poor
manufacturing practices.
• Falsified products packaging may have missing or
misplaced expiry dates, lack instructions or
manufacturing information, not have a batch
number, or differ from the genuine packaging in
many other ways.
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CONSULTANCY
45. Expiry date
• Placement
• Ink (types of faked inks)
• Missing or not.
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CONSULTANCY
46. Visual Inspection and Package
Technologies
• Sometimes poorly written instructions and
spelling errors expose fake Products; poor-
quality inks may dissolve in water .
• Similarly, the Products (drugs) may be the
wrong color, size, or shape, have the wrong
markings on them, have a different coating or
texture, or be otherwise different from what is
expected.
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47. Visual Inspection and Package
Technologies
•
Sometimes the differences are obvious: fake
Viagra seized in Hungary was pink instead of
the well-known blue color of the genuine
product. Further analysis revealed that the
tablets contained 15 milligrams of
amphetamine instead of the correct active
ingredient.
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CONSULTANCY
48. Visual Inspection and Package
Technologies
•
Visual inspections are often unreliable because
substandard and falsified Products (drugs)s
and their packaging often appear identical or
very similar to the genuine products.
•
Criminals have copied holograms, barcodes,
packaging styles, and tablet colors and
markings with astonishing accuracy.
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
49. Visual Inspection and Package
Technologies
•
Microscopic packaging analysis can identify some of these
very careful copies. Under magnification, fine differences in
printing, imprints, and alignment become clear.
•
The next picture shows a high-magnification comparison of
the lettering on a legitimate and fake blister pack. As this
illustration suggests, visual inspection alone is not adequate
to test for Products (drugs) quality.
•
Though a trained inspector can draw conclusions about
Products (drugs) quality by visual inspection, physical
analysis is generally a more reliable way to identify fakes.
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
50. Visual Inspection and Package
Technologies
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
51. Country of Origin
•
The country of origin must be visibly printed on the
product and packaging. For example, products
manufactured in Vietnam should be labeled as ‘Made
in Vietnam.
•
Note that you are not allowed to transship a product to
a third country for relabelling. The same applies to
repackaging or minor adjustments made for the sake
of claiming that a certain product was manufactured in
a different country.
Examples
•
Made in China
•
Made in Vietnam
•
Made in the United States
•
Made in Germany
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53. CPSIA Tracking Label
•
Toys and other children’s products imported or
manufactured in the United States must carry a
permanent CPSIA tracking label.
•
Manufacturer name
•
US address
•
US phone number
•
Website
•
Date of production
•
Production location
•
Batch number
The purpose of the tracking label is to ensure that
non-compliant and unsafe products can be identified
and returned back to the seller.
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CONSULTANCY
55. Requirements for infant swings
•
Infant swings are subject to surface coating
requirements, lead and phthalate content limits,
third party testing and certification, registration
cards, and tracking label requirements.
•
Infant swings must not be
:
Surface Coating Limit
painted with paint that contains more than 90 ppm
(0.009 percent) lead.
•
Infant swings must not
:
Lead Content Limit
contain greater than 100 ppm (0.01 percent) of
total lead content in any accessible component
part.
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CONSULTANCY
56. Requirements for infant swings
•
If an infant swing is
:
Phthalate Content Limits
marketed to facilitate sleep or contains a toy
intended to be used and attached to the swing,
then plasticized components of infant swings must
not contain more than 0.1 percent of the following
eight specified phthalates: di-(2-ethylhexyl)
phthalate (DEHP), dibutyl phthalate (DBP), or
benzyl butyl phthalate (BBP), diisononyl phthalate
(DINP), diisobutyl phthalate (DIBP), di-n-pentyl
phthalate (DPENP), di-n-hexyl phthalate (DHEXP),
and dicyclohexyl phthalate (DCHP).
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57. Batch number
•
What is a Batch number?
•
The batch number identifies the production
run, manufacturing facility, and country.
•
Example: SKU-YYMM-01-CN
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58. Difference between batch number &
serial number
• serial number is a unique identifier given to a
specific individual item or product.
• Batch number identifies a group of items or
components created from a particular
production run.
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59. Choking Hazards Warning
•
CPSIA Choking Hazard Warnings
•
Choking hazard warning labels are
mandatory as part of CPSIA.
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60. Choking Hazard Warnings
•
WARNING: CHOKING HAZARD – Small parts
Not for children under 3 years.
•
WARNING: CHOKING HAZARD – This toy is a
small ball.
Not for children under 3 years.
•
WARNING: CHOKING HAZARD -Toy contains a
small ball.
Not for children under 3 years.
•
WARNING: CHOKING HAZARD – Children under 8
years can choke or suffocate on uninflated or
broken balloons.
Adult supervision required.
Keep uninflated balloons from children.
Discard broken balloons at once.
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61. CHOKING HAZARD
• WARNING: CHOKING HAZARD – This
toy is a marble.
Not for children under 3 years.
• WARNING: CHOKING HAZARD – Toy
contains a marble
Not for children under 3 years.
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64. FCC Labelling Requirements
•
The FCC (Federal communications
Commission) compliance mark signals to
the consumer that the electronic product is
compliant with all applicable FCC
regulations, concerning electromagnetic
interference. The FCC compliance mark
should either be permanently affixed on
the product or the manual – assuming the
product itself is too small for the FCC
mark.
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65. UL Mark
•
The Underwriter Laboratories (UL) symbol
indicates that the product is either
manufactured by a UL listed supplier or
that that the product has passed the UL
testing and certification process. As such,
you cannot affix the UL mark to a product
that is purchased from a non-UL listed
supplier or has not passed their testing
procedure.
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66. UL Mark
UL Marks
•
UL Listed
•
UL Certified
UL Standards Examples
•
UL 1642 – Standard for Lithium Batteries
•
UL 20 – General-Use Snap Switches
•
UL 2595 – General Requirements for Battery-Powered
Appliances
•
UL 2089 – Standard for Vehicle Battery Adapters
•
UL 1740 – Standard for Robots and Robotic Equipment
•
UL 879A – Standard for LED Sign and Sign Retrofit Kits
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67. CE Marking
Discuss in groups the available markings
for electronic & electrical equipment's
taking into account the CE marking.
•
CE stand for = Conformity Europe
•
CE mean that the product complies with
environmental, safety and health
requirements.
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69. The Federal Hazardous
Substances Act
• The Federal Hazardous Substances Act
(FHSA) requires that certain types of toxic
and hazardous household products, such
as strong carry storage instruction and
general safety labels. Note that FHSA is
applicable to all household products that
fall within any of the following
classifications:
FALCON AMBITIOUS FOR TRAINING &
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70. The Federal Hazardous
Substances Act
•
Toxic
•
Corrosive
•
Flammable
•
Combustible
•
Irritant
•
Strong sensitizer
FHSA product examples
•
Cleaning products
•
Cosmetics
•
Art materials
•
Charcoal
•
Chemistry sets
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71. FHSA label information
•
Manufacturer or seller identity
•
Address
•
Hazardous ingredients
•
Signal word: Danger, Poison, Caution and/or
Warning (depending on the classification)
•
Hazard (e.g. Flammable, Causes burns etc)
•
Precautionary safety statement/instructions
•
First aid treatment information
•
Information about storage or handling
•
The statement “Keep out of the reach of
children”
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72. Why your product may need
more than one label
•
It’s often the case that more than one label is
applicable to a certain product. Textiles, for
example, must both have the textiles label,
which includes both the fiber composition and
ASTM care symbols – and the country of
origin.
•
Another example is electronic toys, which
may need to carry the following labels:
- CPSIA tracking label
- FCC symbol
- Country of origin
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109. Product Packaging Inspection
• The visual packaging inspection inspects a
wide variety of packaging types,
packaging materials and coatings. The
visual inspection should focus on possible
defect types such as cracks, or misprints
are detected, classified and localized in
real time.
FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
110. Product Packaging Inspection
• Detection of different types of defects (missing
pieces, dents, scratches, geometric deviations,
missing contents)
• Detection of printing errors
• Wide variety of materials, colours and surfaces
• Real-time defect detection during production
• Classification of defects
• Localization of defects
FALCON AMBITIOUS FOR TRAINING &
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111. Special Packaging, Cans, Bottles
• The visual inspection should also focus on
the special packaging types, such as cans
or bottles, which our solutions inspect
reliably and in real time for various
defects.
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113. How visual inspection ensures your
products meet industry standards
FALCON AMBITIOUS FOR TRAINING &
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•The goal of a visual inspection is to find anything that
might be wrong with the asset which could require
maintenance.
•To ensure that the part, material, or component
confirms the established standard.
•The main objective of inspection is to meet customer
requirements, wants, and needs.
114. Visual Inspection
The graphical representation displays the 14
most common labelling and packaging defects
encountered which could result in a costly
product recall if left unaddressed. The defects
can be categorized into 5 main areas:
• Package integrity
• Code reading problems
• Labelling errors
• Fill levels
• Package forming
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118. What is a
cosmetic?
• A cosmetic is a
product, except soap,
intended to be
applied to the human
body for cleansing,
beautifying,
promoting
attractiveness, or
altering the
appearance.
FALCON AMBITIOUS FOR TRAINING & CONSULTANCY
119. Cosmetics
Labelling
Labelling may be considered
misleading not only because a
label statement is deceptive
but also because a material
fact is not revealed on a label.
A fact may be material in light
of a statement made on a label
or because certain
consequences may result from
the recommended use of a
product.
FALCON AMBITIOUS FOR TRAINING & CONSULTANCY
120. When is a cosmetic also a
Products (drugs)?
•
A cosmetic is also a Products (drugs) when it is intended
to cleanse, beautify or promote attractiveness as well as
treat or prevent disease or otherwise affect the structure or
any function of the human body.
FALCON AMBITIOUS FOR TRAINING & CONSULTANCY
121. When is a cosmetic also a
Products (drugs)?
•
A cosmetic is legally also a Products (drugs) if it is
intended to exert a physical as well as a physiological
effect because the FD&C Act defines in section 201(g) the
term "Products (drugs)" to mean, among other things,
"articles intended for use in the ... cure, mitigation,
treatment, or prevention of disease ... and ... articles ...
intended to affect the structure or any function of the body
..."
FALCON AMBITIOUS FOR TRAINING & CONSULTANCY
122. Package
• A container or wrapping, other than a
shipping container or wrapping, in which a
consumer commodity is delivered or
displayed to retail purchasers.
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123. Package
• The term package is defined in the Fair Packaging and
Labelling Act [sec. 10(b)] and the Code of Federal
Regulations [21 CFR 1.20].
• Essentially, the "package" is the outer container of a
product as, for example, a box or folding carton.
However, the "package" can also be the immediate
container, e.g., bottle, jar or aerosol can that holds the
product if the immediate container is not displayed in
a box or folding carton.
FALCON AMBITIOUS FOR TRAINING & CONSULTANCY
124. Label
•
A written, printed or graphic display of
information...
- on the container of a cosmetic
•
affixed to or appearing on a package
containing a consumer commodity
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125. Labelling
•
All labels and other written, printed or
graphic material on or accompanying a
product in interstate commerce or held for
sale.
•
This includes labels, inserts, risers, display
packs, leaflets, promotional literature or
any other written or printed information
distributed with a product.
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126. Principal Display Panel (PDP)
•
The part of a label that the consumer sees
or examines when displayed for retail sale.
•
A label may consist of more than one
panel. It may consist of a front panel, side
panels and a back panel. Back and side
panels are generally called information
panels.
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127. Principal Display Panel (PDP)
•
The FP&L Act also defines for consumer
commodities, or packages containing a
consumer commodity, the term "principal
display panel," otherwise known for short as
PDP.
•
The "principal display panel" is that part of a
panel that is most likely to be shown or
examined under customary conditions of
display for retail sale. Usually, it is the front
panel of the label of the outer package.
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137. Important Definitions
• Name of the cosmetic product means the name given
to a cosmetic product, which may be an invented
name, together with a trade mark or the name of the
manufacturer;
• Immediate packaging means the container or other
form of packaging immediately in contact with the
cosmetic product;
• Outer packaging means the packaging into which is
placed the immediate packaging;
• Labelling means information written or printed or
graphic matter on the immediate or outer packaging
and any form of leaflets;
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139. Tamper-Resistant Packaging
• Liquid oral hygiene products (e.g.,
mouthwashes, fresheners) and all cosmetic
products (e.g., douches, tablets supplements)
must be packaged in tamper-resistant
packages when sold at retail.
• A package is considered tamper resistant if it
has an indicator or barrier to entry (e.g.,
shrink or tape seal, sealed carton, tube or
pouch, aerosol container) which, if breached
or missing, alerts a consumer that tampering
has occurred.
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140. Tamper-Resistant Packaging
• The indicator must be distinctive by design (breakable
cap, blister) or appearance (logo, vignette, other
illustration) to preclude substitution.
• The tamper-resistant feature may involve the immediate
or outer container or both.
• The package must also bear a prominently placed
statement alerting the consumer to the tamper-resistant
feature.
• This statement must remain unaffected if the tamper-
resistant feature is breached or missing
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141. FALCON AMBITIOUS FOR TRAINING &
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What Is Tamper Evident Packaging?
Tamper evident food packaging is designed with special
closures that make it apparent if the container has been
opened, unsealed, or broken.
Types of Tamper Evident Packaging
There are different types of tamper evident food containers for
restaurants on the market
142. FALCON AMBITIOUS FOR TRAINING &
CONSULTANCY
Tamper Evidence Labels
Tamper evident labels can be
used on any takeout container,
making it easy to pair them with
the packaging you already have
in stock. Once a label is placed
over a package, it can’t be
unsealed without leaving visible
evidence of tampering.
tamper evident bags protect
food containers as well as other
items like condiments, napkins,
and plastic cutlery
Tamper Evident Tape
144. INFORMATION ABOUT COSMETIC
INGREDIENTS
• With the increasing numbers of published
reports and discussions on the safety concerns
of cosmetic ingredients, consumers may often
ponder whether the ingredients may present
a health hazard.
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152. Hologram
•
Many pharmaceutical companies use overt anti-counterfeiting technologies
(OACTs), such as holograms, to fight counterfeiters.
•
An OACT is typically implemented on the Products (drugs) packaging,
which makes it difficult for counterfeiters to produce convincing copies and
easy for patients to tell the difference between authentic and counterfeit
Productss. I consider a model in which an authentic firm sells its Products
(drugs) at a reliable source and counterfeiters and illegitimate genuine
sellers sell their Products (drugs)s at a dubious source.
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153. Hologram Definition
• A three-dimensional image reproduced
from a pattern of interference produced
by a split coherent beam of
radiation (such as a laser) also : the
pattern of interference itself.
• Holography is a technique that facilitates
the display of three-dimensional effects
or images to the viewer.
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156. Hologram & Counterfeit
• According to the Global Brand
Counterfeiting Report 2018-2020, the
amount of total counterfeiting globally
has reached 1.82 Trillion USD by the year
2020, which includes counterfeiting of
high-end consumer goods. Thus, new
approaches must strengthen to fight
against illegal counterfeit goods.
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158. Hologram Stickers Boost Brand
Protection
.1
QR Security Label with Hologram Strip
•
Quick response code hologram, also called QR code
hologram, has two basic elements, i.e., hologram images
and QR code system. If the QR code is simply for
verification purposes, then the hologram image is for
unique security purposes. The randomly rotating text is
carved adopting the patented production process,
physical measures included. The great combination of
them can provide cutting-edge security precautions for
brands and have a user interaction purpose.
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159. Hologram Stickers Boost Brand
Protection
.2
Variable QR Code Holographic Security Label
•
A variable QR code holographic security label is
created using variable data in both 2 and 3
dimensions. Variable data is presented on the
holographic security label using the dot matrix
system. Different QR hologram codes can be inserted
into the dynamic image as well.
FALCON AMBITIOUS FOR TRAINING &
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160. Hologram Stickers Boost Brand
Protection
.3
Hologram 3D Code Security Label
•
In hologram 3D code security labels, holograms are intrinsically
suited to be the best option for 3D-coded structural diagrams. The
content generation can be used for display and digital holography.
can be embedded in the content as
hologram QR codes
Similarly,
well.
•
A multi-layer hologram with a minimum of two different images is
used to manufacture the hologram 3D code security label. It
combines the optical medium with the photosensitive layer to
create a multi-layer body for the security element.
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168. Conclusion
•
Increasingly, an important aspect of consumer protection is to secure
the supply chain by implementing traceability and counterfeit
protection. It is important to distinguish between anti-counterfeiting
QR
and
hologram
solutions and supply chain technologies. Combining
will not be the solution. In few words, a QR code is generally
codes
system or to provide useful information about
track and trace
used as a
-
anti
the product. On the other hand, the hologram is used as an
. It is understandable that the customer may
counterfeiting solution
become a bit confused by the utility of these solutions. Therefore, the
authentication system is not an asset. It is imperative to understand
the differences.
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170. Holographic labels
•
Holographic labels produced by a specialty security printer Eltronis,
have aided two pharmaceutical companies to rebuild confidence in
their brands by securing their products against counterfeit Products
(drugs)s flooding the market.
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171. hologram-embedded safety seal
•
Glaxo first used a tamper-evident hologram to seal packs of Zantac in 1989
•
Supplement fights fakes with hologram-embedded safety seal
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