Ensuring Data Integrity in Pharma Companies: Practical Steps to Take Today - Pharmision Barcode India

 

The pharmaceutical industry faces mounting pressure to meet stringent compliance standards by global drug regulators. As a result, the FDA emphasizes the critical role of data integrity in Good Manufacturing Practices. Despite this emphasis, FDA warning letters continue to cite data integrity as a failure, with recent years witnessing an increase in citations after a temporary decrease in 2017-2019.

Although the recent 483s citing data integrity have yet to reach nearly 80%, as witnessed in FY2016, it continues to be a problem that the FDA-governed industry struggles with. Moreover, the deficiencies continue to be the same as they were a decade ago

How can pharma companies ensure data integrity?

To maintain data integrity throughout processes and ensure consistency, organizations can implement fundamental changes that are easy to implement and provide long-lasting benefits. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/ensuring-data-integrity-in-pharma-companies-practical-steps-to-take-today/

Why Must Pharmaceutical Companies Switch to eLog Management Solutions? - Pharmision Barcode India

 

According to FDA’s 21 CFR Part 11, recording and maintaining equipment usage, cleaning, and other GMP activities with the necessary audit trails is essential. Yet, despite its significance, log documentation today is still primarily a time-consuming, paper-based process that puts life sciences manufacturers at serious compliance risk.

Data entry by hand in paper logbooks is labor-intensive and prone to error. First, employees spend hundreds of hours creating, reviewing, and approving logs. Then, during audits and inspections, they waste more time locating this information, which is often stored in various physical locations.

Drawbacks of paper-based log management

The pharma industry has historically needed to be faster to adopt new technology. As a result, many companies continue to follow paper-based log management. However, here are some challenges with this manual and paper-based approach:

Reduced productivity: Manually recording log activities uses many resources. Equipment usage logs take time to physically (and methodically) record the date, time, product, and lot number of each batch. It takes just as long to register the necessary cleaning data. As a result, productivity is severely impacted by manual log management. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/why-must-pharmaceutical-companies-switch-to-elog-management-solutions/

Automation & Digital Transformation – In the Pursuit of Excellence - Pharmision Barcode India

 

As guardians of human health and life, research and innovation are the non-negotiables for pharma professionals. More than anything else, pharmaceutical companies who tirelessly keep transitioning from one process to another have realized that they need to elevate collaboration between people, equipment, and tech.

Organizations have realized the importance of knowing when they can and they need to produce various drugs, the need for timely delivery, and the urgency of being present whenever there are patient needs. This is accomplished by maintaining a strong network of distribution to establish their brand value and equity.

What automation will mean then

Old school processes require extensive manual intervention from workers and employees. Automation helps eliminate this need and increase quality levels of the output for continuous manufacturing – that is fast spreading across key players for its ability to produce medicines in an end-to-end manner in a single production line. In other words, automation will help reinvent and reimagine how organizations can manufacture medicines with optimized capabilities and how much they can scale while being in line with all regulatory compliances from start to finish! Read more....

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How Pharma 4.0 will revolutionize the Pharmaceutical Industry - Pharmision Barcode India

 

The pharmaceutical industry has been undergoing a massive overhaul. There’s a paradigm shift that is going on, to further improve productivity and quality. And the Pharma 4.0 initiative is the benchmark that the industry is trying to gradually upgrade to.

Through digitalization and the use of smarter tools and processes, Pharma 4.0 is expected to not only improve productivity but also ensure better quality and save time and costs, among several other benefits.

ISPE (International Society for Pharmacoepidemiology) is in the process of developing the roadmap to introduce Industry 4.0 to the pharmaceutical industry as Pharma 4.0.

What is Pharma 4.0?

Developed in 2017, Pharma 4.0 is an ISPE initiative that aims to improve the processes throughout the life cycle of pharmaceutical products with the help of modern smart technology.

It aims to do so by aligning the pharmaceutical industry with the philosophy of Industry 4.0. Read more.....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/how-pharma-4-0-will-revolutionize-the-pharmaceutical-industry/

Top 3 Challenges in Pharma Manufacturing Today - Pharmision Barcode India

 

Stricter regulatory requirements, the need for better quality control, supply chain disruptions, and cost pressures have had significant impacts on pharma manufacturing in recent years.

Pharma manufacturers today must carefully reevaluate their long-term decisions in sourcing, manufacturing, and supply chain in light of factors like the COVID-19 pandemic, strict FDA regulations and supply chain disruptions owing to geopolitics and other causes.

This article explores the top 3 challenges facing pharma leaders today and the steps they can take to develop a more strategic, long-term, and integrated approach to tackle these issues.

Need for better quality control

In the pharmaceutical industry, quality control is of utmost significance. There are numerous reasons why quality control is the cornerstone of this industry, including the need to adhere to stringent local, national, and international regulations as well as quality standards for goods produced for human consumption.

The manufacturing environment must also adhere to very strict standards. To oversee the plant and production for all of these activities, qualified personnel must be well-trained. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/top-3-challenges-in-pharma-manufacturing-today/

7 Benefits of Warehouse Automation in the Pharma Industry - Pharmision Barcode India

 

With the introduction of the Pharma 4.0 guidelines, the pharmaceutical industry has been undergoing a sea change when it comes to embracing new technology. The industry understands how process automation can completely change the way businesses are run and how it enables them to optimize processes, improve data collection and storage, deliver higher quality than ever at significantly lower costs, and at a considerably reduced time-to-market.

Process automation has also transformed warehousing in the pharmaceutical industry. A vital part of the supply chain lifecycle, warehousing in the pharma industry is especially crucial given the strict regulatory quality and safety compliances demanded from the industry. It’s no wonder that pharma warehouses across the globe are becoming smarter with each passing day. Automated Warehouses are often equipped with Warehouse Management Systems to optimize daily processes.

Warehouse Management Systems (WMS)

Warehouse Management Systems are a set of tools and software that automate warehouse operations. They enable warehouse managers to have better control by automating daily processes such as storing, labeling, and tracking inventory, managing workers and their operations, analyzing captured data, and carrying out routine checks. WMS is seamlessly integrated into warehouse operations with no downtime required for installation, making them easy to adopt for any organization looking to opt for it. For the pharmaceutical industry, all WMS must be GMP and 21 CFR part 11 compliant solutions and meet all ALCOA+ requirements. Read more....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/7-benefits-of-warehouse-automation-in-the-pharma-industry/

Why Data Integrity is Important for FDA Regulated Companies - Pharmision Barcode India

 

The Food and Drug Administration (FDA) has always stressed the importance of data integrity as part of Good Manufacturing Practice.

Despite that, FDA warning letters issued each year continue to cite it as one of the failures. While the number of citations decreased in the period 2017-2019, it has witnessed an upward surge yet again in recent years.

Although the recent 483s citing data integrity have not reached the figures of close to 80% as witnessed in FY2016, it continues to be a problem that the FDA-governed industry continues to struggle with. Moreover, the deficiencies continue to be the same as they were a decade ago.

It is important to note that FDA has not made any changes to the definitions or regulations or expectations in recent years. There have not been any new guidelines or regulations in the category. This clearly indicates that it is the companies who have not been able to implement the requirements satisfactorily. Read more...

Source Link:- https://www.pharmision.barcodeindia.com/blogs/why-data-integrity-is-important-for-fda-regulated-companies/