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....

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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....

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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...

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Here’s why you should switch to eLogbooks today - Pharmision Barcode India

 

The pharmaceutical industry has been rapidly adopting Pharma 4.0 principles. In case you are not aware of the concept, it is an ISPE initiative that aims to improve the processes throughout the life cycle of pharmaceutical products with the help of modern smart technology in line with the philosophy of Industry 4.0.

Although Pharma 4.0 is currently being considered a source of competitive advantage rather than a must-have, it won’t take too long for it to become an absolute need for the pharmaceutical industry. Eventually, the industry must undergo that transformation, go for that upgrade and embrace Pharma 4.0.

Having said that, upgrading to and implementing Pharma 4.0 does have a cost impact, so most companies are choosing to make small changes at a time and then gradually scaling up before eventually migrating completely to Pharma 4.0.

One great (and inexpensive) first step is adopting an eLogbook solution. Using Electronic Logbooks instead of using paper logbooks has several advantages and it’s easier to embrace advanced technological solutions when you see the results you get by introducing tech solutions such as eLogbooks into your processes.

So, is an eLogbook just your usual paper-based logbook in a digital form? You might be thinking. Read more....

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Digitizing Shop Floor Operations for Pharma Manufacturing Excellence - Pharmision Barcode India

 

A survey of US-based manufacturers carried out by PwC and The Manufacturing Institute found that 73% are planning to increase their investment in smart factory technology over the next year.

The study also points towards a definitive and inevitable shift to Industry 4.0 as Pharma companies seek to integrate new technologies into their supply chains and manufacturing operations.

Digitizing shop floor operations helps Pharma manufacturers keep track of, schedule, and accurately record events in their manufacturing facilities.

Traditionally, shop-floor managers had to manually monitor activities on the factory floor in the majority of manufacturing settings. These manual techniques typically involve monitoring production batches using paper-based systems used intermittently throughout the day.

Not only was this manual approach time-consuming but it also did not give decision-makers the data-supported insights they need to manage the production process. As a result, managers were forced to deal with issues in a ‘reactive’ rather than ‘proactive’ manner.

With the advent of cutting-edge technology, digital shop floor control systems allow manufacturers to give factory floor workers real-time visibility into the production line and other important activities, enabling managers to better control their manufacturing processes, spot issues quickly, and use the power of analytics for pre-emptive measures. Read more.....

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3 Ways to Increase Productivity and Quality in Pharmaceutical Manufacturing - Pharmision Barcode India

 

Did you know that according to the 2019 PhRMA member annual survey, members of the Pharmaceutical Research and Manufacturers of America (PhRMA) trade association spent a record-breaking $79.6 billion on research and development in 2018?

Pharma manufacturers the world over are focusing on innovation to increase productivity and product quality due to growing competition, shifting regulatory requirements, disruptive technology, and several other considerations.

So, how can manufacturers improve quality and productivity?

Here are three practical steps to take:

1. Automating Manufacturing processes

The pharmaceutical sector has some of the strictest quality standards in the world. Everything in the process, from creating the items to labeling the packaging to sanitizing the tools used, needs to be carefully under control. Read more....

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How Can Pharma Companies Avoid Data Integrity Issues? - Pharmision Barcode India

Did you know that 65% of warning letters issued by the FDA cited data integrity problems in 2021? That is a massive spike from 2020, where 51% of the 483s cited data integrity as a problem. Data integrity is a critical topic in pharma manufacturing. Despite the FDA’s ‘set-in-stone’ guidelines, we see numerous 483s citing data integrity as an issue each year. And this problem exists globally.

What is data integrity?

Data integrity is the practice of maintaining and ensuring the accuracy of data consistently during the manufacturing of a product. All records during the manufacturing process need to be validated as per FDA’s guidelines. Any change to the data without reflecting in the records is considered a failure of data integrity.

It involves ensuring which user created and saved a record along with date and timestamps and that all data is accurate, consistent, and complete, making it reliable and trustworthy.

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 the companies have not been able to implement the requirements satisfactorily.

To ensure data integrity, pharma manufacturers need to ensure all data meets the guidelines outlined in the ALCOA acronym:

1. Attributable – All information about the person collecting the data, the origin of the data, and the timestamp of data collection.
2. Legible – Data should be easy to read.
3. Contemporaneous – All data must be recorded as and when the activity is done.
4. Original – The original data records need to be preserved throughout their life cycle and be long-lasting.
5. Accurate – Data needs to be error-free and high quality, with all changes being reflected in the supporting documentation.

For more information, visit https://www.pharmision.barcodeindia.com/blogs/how-can-pharma-companies-avoid-data-integrity-issues/