Serialization System Validation

Serialization System Validation

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...
The need for automation

The need for automation

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...
How effective is your EMVO Alert Management Strategy?

How effective is your EMVO Alert Management Strategy?

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...
Importance of Serialization Project Management

Importance of Serialization Project Management

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...
Medical Devices EU regulations for MDR – Part 1

Medical Devices EU regulations for MDR – Part 1

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...
SFDA Dossier requirements

SFDA Dossier requirements

  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...
The trending supply chain technologies in 2021

The trending supply chain technologies in 2021

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...
What is VRS?

What is VRS?

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...
Preparing for Serialization in Indonesia

Preparing for Serialization in Indonesia

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...
How to best start preparing for Serialization in Brazil

How to best start preparing for Serialization in Brazil

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....

Aggregation and its Importance to Pharmaceutical Companies

  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...

Implications of Brexit on the UK Pharmaceutical industry

      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)...

Avoiding Mismanagement of Master Data

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...

Celebrating a Milestone!!

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...

How can track-and-trace solutions contribute to ROI?

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...

How organized crime can impact Covid-19 vaccines

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...

Counterfeit Drugs during COVID-19

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...

What are the Current Trends in Regulatory Compliance?

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...

How to drive Successful Serialization in the Supply Chain?

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...

How can the pharma industry prepare for Brexit?

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...

Serialization Challenges and Opportunities for Businesses

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...

How have Pharma Supply Chains changed post Covid-19?

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...

Abbreviated Serialization Terminology You Must Know

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...

Key Challenges to 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...

The Importance of Information Technology in 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...

The Importance of Master Data in 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...

How important is it to aggregate after 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...