Why Pharma Companies Need to Automate Manufacturing Processes Today - BCI Pharmision

 

The tragic news of 66 Gambian children dying after consuming Indian cough syrups has sent shockwaves through the world.

The WHO has said that it has found ‘unacceptable amounts’ of diethylene glycol in the syrups, which when consumed can cause life-threatening gastrointestinal symptoms.

Despite the Food and Drug Administration (FDA) stressing on adherence to regulatory compliances, there are several companies in the world today that are failing to do so. There is no tolerance for error in the pharmaceutical industry and the unfortunate tragedy that occurred is a stark example of the repercussions of non-compliance.

Speaking of non-compliance, a few alarming trends emerge when we go over the warning letter issued by the Food and Drug Administration (FDA) between FY2013 and FY2018 (refer Table 1 below).

The number of warning letters issued keep going up each year and a majority of the 483s cite data integrity as an issue. In FY2018, for example, data integrity deficiencies were cited in 57 percent of all warning letters (excluding those issued to compounding pharmacies).

Yes, the FDA has become stricter with their inspections each year, but warning letters issued over the years indicate that many pharmaceutical companies continue to struggle to meet the compliance criteria for a few basic, yet critical rules.

These observations raise a bunch of questions…

Why are so many pharmaceutical companies failing to meet certain compliance criteria time and time again?

What is the root cause behind some problems persisting over the years, such as lack of data integrity?

Is it a competence issue with staff or does the fault lie with the SOPs?

And what are the companies complying with the regulations doing differently?

Table 1: Breakdown of FDA 483s for the period FY2013 to FY2018

Source: An Analysis of FDA FY2018 Drug GMP Warning Letters (pharmaceuticalonline.com)

Over the years, the Food and Drug Administration (FDA) has cited the failure to implement a reliable process monitoring program to ensure better control over the manufacturing process as a problem area pharma companies should work on.

The obvious information that we can glean from this is that pharma companies need to embrace automation and digitization in order to meet the compliance criteria. With the industry known for its stringent guidelines, this should have seemed obvious. But, according to a global McKinsey study, the pharma industry ranks quite low in terms of digital maturity and has been slow to adapt to new technology. For more information, visit https://www.pharmision.barcodeindia.com/blogs/why-pharma-companies-need-to-automate-manufacturing-processes-today/

7 Benefits of Warehouse Automation in the Pharma Industry - BCI Pharmision

 

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.

Benefits of warehouse automation

There are several benefits to automating warehouse operations. While some benefits, such as an increase in efficiency and a safer work environment, are immediately obvious, other benefits take a while to be noticed. For the sake of brevity of this article we have mentioned only seven benefits:

Improved Operational Efficiencyc

One of the biggest reasons why most pharma companies opt for warehouse automation is to improve their efficiency. It allows them to increase capacity and refine their processes thanks to the level of optimization possible with the latest technology in warehouse automation. Improved operational efficiency has a direct correlation with KPIs such as time, cost, quality, and productivity, which means it also has a huge positive impact on the business.

Minimized Errors

Automating warehouse processes reduces the chance of human error, which can be extremely dangerous in the case of a sensitive industry such as pharma, where stringent standards and complex regulations are to be met. Automating manual processes such as data collection, handling, and analyzing ensures that the information recorded is reliable and error-free. This can assist the pharmaceutical industry to meet stringent standards and complex regulations. Minimizing errors in a warehouse also benefits a company by reducing wastage and loss.

Optimized cost

While warehouse automation requires a company to invest first, the ROI on it is surprisingly quick. This is due to the fact that automation saves a lot of time and considerable cost through increased efficiency, optimized storage space, improved quality, higher productivity, and substantially minimized error, wastage, and loss. This is another reason why the pharma industry has witnessed a rise in the number of companies opting for warehouse automation solutions. Not only does deploying warehouse automation bring a competitive edge to a company but it also helps make greater margins of profit in the long run.

Better Quality Control and Assurance

Quality Control and Quality Assurance are of prime importance in the pharma industry, with numerous tests being carried out throughout the lifecycle of the product even while at the warehouse. The industry has greatly benefitted by automating all warehouse processes related to QA/AC, from sampling to labeling, to calibration and validation of the products. Warehouse automation is also convenient when it comes to the frequent quality audits that are typical to the pharma industry.

Improved Data Analytics and Integrity

Automating data collection and analysis has a number of benefits. First, a large amount of data can be collated, processed, and analyzed with precision, meaning that a large amount of data is gathered and processed accurately in a relatively short amount of time. Data Integrity is extremely critical in the pharma industry, owing to the strict standards and regulations that are to be met. It also helps during audits, when the people in charge are confident that the data is authentic and error-free.

Sustainability

An added advantage of adopting warehouse management solutions is that it enables business owners to achieve their environment-related goals. Automated warehouses optimize resource usage and space, reduce losses, and also enable considerable energy savings, which make it an excellent choice for businesses looking to attain their sustainability goals. The best part about automating warehouses is that sustainability comes as a natural by-product owing to the optimized performance that the use of technology enables. For more information, visit https://www.pharmision.barcodeindia.com/blogs/7-benefits-of-warehouse-automation-in-the-pharma-industry/