The Turkish “Pharmaceuticals Track and Trace System” (generally abbreviated as ITS) defines the infrastructure constructed to track and trace all units belonging to each pharmaceutical product in Turkey. ITS is an application of the infrastructure that is known as “Track & Trace” in the literature.Datamatrix code is used instead of formerly used barcode to ensure the uniqueness of the units. Every single step and action of the unit in the supply chain is gathered by web services to provide the traceability.
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This presentation mainly deals with clinical development of biosimilar products. It also gives enough on non-clinical development so that the audience is well oriented.
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SUPAC Guidelines :
1.In component and composition
2.The site of manufacture
3.The scale up batch of manufacture
4.The manufacturing( equipment and process)
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The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
The highlights of this presentation covers importance of drug labeling, general labeling provisions, labeling requirements for prescription drugs and/or insulin, labeling requirements for over-the-counter (OTC) drugs, exemptions from adequate directions for use, and labeling claims for drugs in drug efficacy study.
Pharmaceutical Packaging and Labelling Summit 2012YunShi
Join us at the the ultimate meeting to hear from Novartis, F. Hoffmann-La Roche, Pfizer, Eli Lilly, Johnson & Johnson, AstraZeneca, Novo Nordisk, Reckitt Benckiser, Mylan Pharmaceuticals as well as other Key pharma professionals including MHRA, SwissMedic and EFPIA who will thrash out the core issues in the packaging and labelling industry
Generic Drugs having low cost. We should know about world drug scenario. In our daily life, we must concern with doctors and take drugs for cure. But we are not aware about drugs.We should know about drugs, not to become a Doctor, but for general awareness or at least to know what we are taking for our helth.
This presentation mainly deals with clinical development of biosimilar products. It also gives enough on non-clinical development so that the audience is well oriented.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
Introduction to Scale up and post approval changes.
SUPAC Guidelines :
1.In component and composition
2.The site of manufacture
3.The scale up batch of manufacture
4.The manufacturing( equipment and process)
It is mandatory for every medicine or pharma packaging to have a unique serial code or UID. Project is to build a web application that will provide tracking capabilities for the UID for pharma packaging of drugs. The track feature (TRACK n trace) will track the UID of each package by using vision based scanners, RFIDs, etc. and store the data into a local server. The server will be synced daily with a global server (we are looking for cloud based hosting platforms such as Windows Azure or amazon web services). We have to build the trace functionality (Track n TRACE) by building a web interface where a person with the UID can trace the shipment.
We have to keep historical records for as long as 10 years and build logic on basis of the UID state. We have to provide the details from the database as in when was this package manufactured, when was it shipped, etc. If the UID entered is faulty for example; it wasn’t ever manufactured or if it is over its expiration date then we have to generate corresponding errors and also maintain a log of such entries and send notification to the admins with details of IP, Geography or where the error generated.
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Pharmaceuticals track and trace system
1. Republic of Turkey
Ministry of Health
General Directorate of Pharmaceuticals and Pharmacy
Pharmaceuticals Track and Trace System (İTS)
Taha YAYCI
10.09.2011
2. Content
• What is İTS?
• Objectives
• Basic Concepts
• Time Plan
• Workflow Diagram
• Web Services
• Participants
• Statistics
• Questions
3. What is İTS?
The Turkish “Pharmaceuticals Track and
Trace System” (generally abbreviated as
ITS) defines the infrastructure constructed
to track and trace all units belonging to
each pharmaceutical product in Turkey. ITS
is an application of the infrastructure that is
known as “Track & Trace” in the literature.
Datamatrix code is used instead of formerly
used barcode to ensure the uniqueness of
the units. Every single step and action of
the unit in the supply chain is gathered by
web services to provide the traceability.
4. Objective
•Ensure the reliable supply of drugs to
patients
•Prevent counterfeiting, fraud, smuggling
and illegal sale of drugs
•Prevent barcode scams
•Support rational drug use, supply data to
control market
5. Basic Concepts
PRODUCT;
•Every single box of a drug. It defines the unique box of a
pharmaceutical tracked by ITS.
GTIN;
•Global Trade Item Number.
•Ensures the uniqueness of a drug universally. Unique number created by GS1 for a
single trade item.
SN;
•Serialization Number printed on the box of a drug. GTIN and SN ensures the
uniqueness of a single box.
PARTICIPANT;
•A person, group, organization, or system who is affected by İTS actions
6. Time Plan
•Project Kick-Off
October 2007
•Demo
August 2008
•Publication of Web Services
November 2008
•Pilot Application
September 2009
•Go Live
January 2010
•İTS Portal, İTS PTS, Hardware
January 2011
7. Workflow Diagram
Put on the
İTS Stockpiled
Stockpiled STOCK
Market?
Product is marked with Sent to the Wholesaler
Sent to the Wholesaler
DATAMATRIX after serialized by
GTIN and SN
İTS
İTS Sell ? Stockpiled
Stockpiled STOCK
WHOLESALER
Sent to the Hospital/Pharmacy
Sent to the Hospital/Pharmacy
STOCK Stockpiled
Stockpiled Consume? İTS İTS İTS Sell ? Stockpiled
Stockpiled STOCK
HOSPITAL PHARMACY
Consume
Consume Sell
Sell
İTS
İTS
Menufacture/Import
İTS
Notification
İTS Sale/Cancel Sale Notification
İTS İTS
İTS Consume/Sale Notification
PATIENT PATIENT
REIMBURSMENT İTS Query Sale
COMPANY or
ASSOCIATION