Oct 21, 2021 | Serialization
Key upcoming updates for Bahrain Traceability October 2021 – MAHs to be certified and reporting shipment information to the MVC Traceability Hub. May 2022 – Aggregation to become mandatory The MAH that export products to Bahrain are required to comply with...
Oct 8, 2021 | Serialization
In today’s world of pharmaceutical serialization where we have dozens of different regulations and laws pertaining to pharmaceutical and medical device serialization across the globe, the Quality Person (QP), Quality Assurance (QA) or Quality Control (QC) team in the...
Oct 1, 2021 | Serialization
Defining the basics Serialization is assigning a unique product identifier to the smallest saleable unit that can be uniquely verifiable. Tracking is understanding the current and past locations of a serialized unit. Trace is to identify the history of all entities...
Sep 24, 2021 | Serialization
Automation has revolutionized manufacturing by boosting production levels to meet increased demand in all industries. The pharmaceutical industry is no exception. The increased demand for vaccines for example has forced many pharmaceutical companies to do more with...
Sep 16, 2021 | Serialization
Introduction To avoid falsified medicines reaching the supply chain, European Medicines Verification Organization (EMVO) has designed a robust alerting functionality to track any potential falsified medicines that reach the supply chain. The EU FMD framework was...
Sep 10, 2021 | Serialization
With an increasing complexity in the pharmaceutical serialization regulation and supply chain requirements across the globe, project management has become an integral part of the pharmaceutical companies to manage their track & trace projects in an effective and...
Sep 3, 2021 | Serialization
Introduction The EU MDR is a new set of regulations that came into effect on 26th May 2021, following a 4-year transition period after being adopted in May 2017. It aims to improve the safety and performance of the device throughout the lifecycle by tightening up the...
Aug 27, 2021 | Serialization
The SFDA Dossier requirements differ for each application. What is important to note is that the CTD provides a format for an MAA (Marketing Authorization Applcication) Also to be noted is that regional and national requirements may affect the content of a...
Aug 20, 2021 | Serialization
SFDA is the regulatory body in Saudi Arabia that handles the registrations and approvals for products that are distributed in Saudi Arabia whether they are locally made or imported. All product placements in the market require an SFDA certificate to protect the market...
Jul 30, 2021 | Serialization
The past decade has seen major breakthroughs in technology and though there have been really great strides, the pace of innovation in technology is still on at an ever increasing pace. Here are some present and rapidly advancing supply chain technologies that you...
Jul 16, 2021 | Serialization
VRS or Verification Router Service is an automated way of verifying saleable returns to improve supply chain efficiency while maintaining the integrity of the supply chain and keeping it free from counterfeit drugs. What are saleable returns? When products are...
Jul 9, 2021 | Serialization
The epidemic has brought in a renewed effort in maintaining strict hygiene and safety standards keeping consumer safety in mind. It is needed for business owners to have clear visibility of the supply chain. Traceability plays an indispensable role in consumer safety...
Jun 24, 2021 | Serialization
Early Implementation In 2017 the Indonesian Food and Drug Authority (BPOM-Bedan Pengawas obat dan Makanan) began the initial implementation of serialization to fight the impacts of counterfeit drugs in the country. It, in turn, became the first ASEAN member state to...
Jun 11, 2021 | Serialization
Key dates in UAE for 2021 September 2021: Aggregation requiredJuly 1, 2021: Implementing the 2D barcode and serialization on the packsMarch 31, 2021: Uploading the data on GS1 UAE portal According to the circular published by MOHAP (ministry of health and prevention)...
Jun 4, 2021 | Serialization
Understanding Saudi Arabia’s Serialization and Aggregation requirements Introduction to the SFDA The Saudi Food and Drug Authority also known as the SFDA has created the standardized RSD identification system to track the...
May 28, 2021 | Serialization
Brazil’s legislation has had a complex set of requirements for putting into effect their serialization and reporting processes in order to achieve complete compliance. Back in 2016, ANVISA signed the National Medicine Control System SNCM into law (Law No....
May 7, 2021 | Serialization
What is EU FMD? The EU FMD framework was initially put into place on 9th February 2019 to track any potential falsified medicines that reach the legal supply chain to ensure patient safety throughout the member countries. From that date onward, all products...
Apr 23, 2021 | Serialization
Focusing on manufacturing and packaging stagesHaving an organized and efficient serialization inventory is essential for organizations to manage the supply chain effectively. It becomes difficult to efficiently process the inventory in mixed environments that contain...
Apr 16, 2021 | Serialization
The recently announced TGO 106 guidance by the Australian government department of Health provides guidance to sponsors and manufacturers supplying medicines in Australia. Even though serialization and use of data matrix codes at this time continues to be optional,...
Apr 9, 2021 | Serialization
What is Aggregation? In short, aggregation is the undertaking of creating a hierarchic relationship between distinctive identifiers assigned to packaging containers. Companies have been complying with Serialization guidelines for a while now, i.e., the process of...
Apr 2, 2021 | Serialization
The United Kingdom voted to leave the European Union in 2016, but it wasn’t until December 24th 2020 that the details of trade between the two countries was solidified. On that date, the two entities signed a 1,250-page Trade and Cooperation Agreement (TCA)...
Mar 26, 2021 | Serialization
The EU Falsified Medicines Directive (FMD) puts in a framework to track any potential falsified medicines that reach the legal supply chain. Individual units are scanned at the dispensary to verify their legitimacy. In case of any verification failures, the...
Mar 19, 2021 | Serialization
The plan you choose to improve transparency in your supply chain will depend on the risks in your business and what problems you wish to solve with the data you receive. For example, do you wish to ascertain the origin source of your raw materials? Do you want to be...
Feb 26, 2021 | Serialization
The need for serialization One of the constant battles the pharmaceutical industry has to face, is to prevent counterfeit and falsified drugs from entering the market and putting the public’s health at risk. The fraudulent products and drugs may be manufactured in...
Feb 19, 2021 | Serialization
Master data management (MDM) is one of the most effective ways to help manufacturers, wholesalers and prescriber companies to work together and ensure the data shared within the network is accurate and transparent. This set of data consists of the most current records...
Feb 5, 2021 | Serialization
Since the beginning of the pandemic manufacturers and packaging suppliers have been trying to meet the sudden surge in demands owing to Covid-19. There was an immediate need for PPE and other medical equipment all at once across the globe. This exposed many...
Jan 29, 2021 | Serialization
With pharmaceutical supply chains growing longer, it has become necessary to incorporate serialization in companies. The issue of counterfeit goods in the market has been a global issue for decades, more so now with longer supply chains and higher demands for goods....
Jan 28, 2021 | Serialization
We are delighted to announce that CosmoTrace has reached an exciting milestone – 1500+ followers on LinkedIn and we could not be more pleased. A huge thanks to all our followers for contributing to the group by sharing, liking and commenting on the posts. We...
Jan 22, 2021 | Serialization
Serialization has become a necessity for pharmaceutical companies and many countries like UK, USA, Italy and India have adopted different levels of serialization in their pharmaceutical supply chains. There are a host of reasons why serialization is being mandated...
Jan 15, 2021 | Serialization
When the Coronavirus initially spread across the globe, governments tried to contain it and prevent increasing cases. Supply chains were impacted because of the increased sudden demand of medical products and equipment which led to a lot of counterfeit products like...
Jan 8, 2021 | Serialization
Tracking-and-tracing of products takes into account supply chain efficiency and also looks at completely functional solutions that target customer pain points for organizations. Track-and-trace solutions, especially digitally, don’t just add value towards a cohesive...
Dec 18, 2020 | Serialization
A safe, secure and effective supply chain needs to be transparent and have all the supply chain partners to work in tandem inorder to track, trace and verify authenticity of products. As Serialization aids in meeting these objectives through assigned unique...
Dec 11, 2020 | Serialization
In our previous article we looked at the impact of counterfeit drugs affecting the pharmaceutical industry during the pandemic. We’re going to explore this a little deeper in this article and see how organized crime is impacting Covid-19 vaccines. We have been made...
Dec 4, 2020 | Serialization
During this global pandemic, counterfeit drugs hit the market and seem to be growing even now at an alarming rate. Although battling such faulty products has been a priority for manufacturers and suppliers, the industry is seeing a wide spread of and huge amounts of...
Nov 27, 2020 | Serialization
Although the Brexit Transition period ends on December 31 2020 at 11 pm in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) believes the exchange and circulation of medical goods may continue till January 1 2021 (as per their update on October 21...
Nov 20, 2020 | Serialization
Regulatory and compliance teams faced immense pressure after Covid-19 spread across the globe. The life sciences industry was trying to inculcate regulatory changes however, the pandemic expedited the need to put these into effect and to address all the new challenges...
Nov 13, 2020 | Serialization
The pharmaceutical industry has been able to prevent excess flooding of counterfeit and harmful products in the supply chain by ensuring compliance measures for serialization and traceability processes are followed. By implementing unique identifiers (such as unique...
Nov 6, 2020 | Serialization
The deadline for Brexit is nearing (December 31 2020) and the industry is anticipating some new regulatory rules and possible disruptions with exports and availability of products. This could have potential lasting effects as the healthcare industry continues to fight...
Oct 23, 2020 | Serialization
It is well known by now that counterfeit medicines can be extremely dangerous and a tremendous health risk for patients. It is one of the biggest battles Pharma companies continue to face irrespective of their location and size. The measures that the industry took was...
Oct 16, 2020 | Serialization
When Covid-19 began spreading across the globe, pharmaceutical supply chains were put through tremendous strain but still managed to keep producing products amidst the crisis thanks to the operational and procurement teams. Even though drug shortages continue to...
Oct 2, 2020 | Serialization
Are you ready for Saudi Arabia’s aggregation requirements? Saudi Arabia didn’t have an efficient process to track human registered drugs manufactured or imported from the country until the set up for the SFDA (Saudi Food and Drug Authority) which established the...
Sep 25, 2020 | Serialization
Here are the last 20 out of a list of 60 abbreviated Serialization terminologies. Some of these terms may be familiar because of common usage, while some may be lesser known. Remember, new regulations and updated technologies in Serialization lead to changing jargon,...
Sep 24, 2020 | Serialization
In our last article, we looked at the first 20 out of a list of 60 abbreviated Serialization terminologies. Here’s the next 20 list of terminologies. As mentioned previously, new regulations and updated technologies in Serialization lead to changing jargon,...
Sep 18, 2020 | Serialization
New regulations and updated technologies in Serialization lead to changing jargon, abbreviations and terminology. A lot of them may be familiar because of common usage while some may be lesser known. In this 3 part article we’re looking at the first 20 out of a list...
Sep 11, 2020 | Serialization
When implementing a serialization strategy, many factors need to be considered from the planning stages itself, such as the locations, production lines, and relevant markets. Without considering these points, it could result in costly delays and could affect the...
Sep 4, 2020 | Serialization
How to identify challenges in serialization implementation and successfully handle them. Falsified medicines have been a problem across the world for decades. The challenges increased exponentially ever since online purchasing options became available, thereby making...
Aug 28, 2020 | Serialization
How does IT factor into serialization strategies? Pharmaceutical companies and governments across the world have adapted to reducing counterfeit goods by implementing product serialization. This requires the entire supply chain to have an extensive and thorough system...
Aug 21, 2020 | Serialization
What is master data, and why is it essential for serialization? One of the significant factors to determine the success of a product’s serialization is to have accurate and verifiable information. The serialization data needs to include information about the...
Aug 14, 2020 | Serialization
When it comes to aggregation in serialization, the effects of it can influence many areas such as the packaging line to the entire supply chain. The hope for a completely digital supply chain that’s fully integrated for manufactures to have visibility of their...
Aug 7, 2020 | Serialization
Millions of lives are put at risk every year because of counterfeit products in the pharmaceutical industry. Governments across the globe have set track and trace regulations and enforced serialization of products to identify these faulty goods in the supply chain as...
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