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/

Pharma Digital Transformation – The Key to a Better Future - BCI Pharmision

The pharmaceutical industry is undergoing a wave of digital transformation. Powered by technologies such as advanced mobile communications, the cloud, advanced analytics, and the Internet of Things, the sector has been able to achieve dramatic results in terms of product quality, costs incurred in production, and time required for manufacturing. Today, pharma executives are well aware of the disruptive potential of embracing and utilizing technology and are experimenting with a wide range of digital initiatives.

However, there are companies that are yet to understand the importance of digital transformation.

A McKinsey study on Digital Quotients (DQ) across sectors on a 100-point scale found that
pharma’s score of 27 lags behind the average of 33 across sectors. It even trails other highly regulated businesses, such as banking (32) and insurance (31). In fact, pharma scores were closer to those of sectors that historically have been digital laggards, including the public and social sectors.

For more information, visit https://www.pharmision.barcodeindia.com/blogs/pharma-digital-transformation-the-key-to-a-better-future/

5 Incredible Benefits of 21 CFR Part 11 Compliant Software - BCI Pharmision

If you maintain records or submit information to the Food and Drug Administration (FDA) electronically, you need to comply with 21 CFR Part 11.

If you are not aware of FDA’s regulation, this article will tell you all you need to know about it, why it’s important for you and the best way to implement it in your organization.

We’ll also tell you briefly about how our 21 CFR Part 11 compliant solution stack makes it super easy for you to not only adhere to the FDA regulations but also benefit greatly from it.

What is 21 CFR Part 11?

In August 1997, FDA issued a set of regulations that enlist its acceptance criteria for all forms of electronic data.

This set of regulations was issued as Part 11 of Title 21 of FDA’s Code of Federal Regulations, simply known as 21 CFR Part 11. It applies to all electronic records that are created, modified, maintained, archived, retrieved, or transmitted. It also gives us guidelines for setting up an FDA compliant, digital Quality Management System, where digital records and signatures are used in place of traditional methods.

The recommendations under 21 CFR Part 11 are in line with Pharmaceutical Good Manufacturing Practice (GMP).

For more information, visit https://www.pharmision.barcodeindia.com/blogs/5-incredible-benefits-of-21-cfr-part-11-compliant-software/

Robust WMS re-shaping the future of Pharmaceutical Supply Chain - BCI Pharmision

 

Why The Pharma Industry Needs a Robust WMS

The global pharmaceutical industry has grown phenomenally over the past decade. This is reasonably so, given the advancement in research and innovation. However, since 2019 there has been a significant impact on this industry due to Covid-19, both on the demand and supply side. Manpower availability and logistics continuity were deeply affected exposing the need for local and regional self-reliance for manufacturing and warehousing. The result of which has been that The World Economic Outlook reported a global growth at 4.4%, considerably lesser by 7% as witnessed in 2019.

However, the Indian numbers for the pharma industry have been buoyant, to say the least. According to FICCI and EY’s Indian Pharmaceutical Industry 2021 report, India is on track to achieve $130BN target sales by 2030, at a CAGR of 12% from 2020-2030. This is much higher than global number predictions. And while India is gunning to become a global supplier of drugs, it is looking to get there by focusing on four key enablers.

Research & Innovation – By not just producing licensed drugs in India, but also actively pursuing research in the field of drugs and testing.

Healthcare access – Actuating deep penetration of healthcare across the country.

Access to medicines – Studying and building globally competitive drug pricing and procurement models so that access to drugs is not blocked.

Strengthening manufacturing and supply base – Decentralizing drug manufacturing and realizing the importance of efficient supply chain and logistics infrastructure.

Manufacturing Encouragement from the Government

India supplies over 60% of global demand for vaccines and over 40% of generic pharma demand in the US. No wonder it’s called the pharmacy of the world. India currently has more than 10,500 manufacturing units across the country, catering to more than 150 countries. To bolster these solid numbers further, the government is encouraging private manufacturers with new schemes and subsidies. The idea is to instill pride of quality in ‘Make in India’.

The offshoot of this nudge is that there will be satellite manufacturing units that will mushroom all over the country. This will, in no way, hamper the manufacturing quality, as stringent testing and manufacturing SOPS will ensure meeting global standards, but where breakage of quality might occur is warehousing and logistics. We know that all through the Supply chain, there is constant and consistent checking and tests. This makes it more crucial to have a seamless and world-class Warehouse Management Software (WMS).

WMS And Its Importance

Supply chains across industries cannot exist without robust warehousing, and this is of utmost significance in the pharma sector. Given its regulations adherence, drugs warehousing must be transparent, error-free, and seamless. Here are some of the other vital strong points of a good Warehouse Management Software.

Inventory Management – Perhaps no other manufacturing industry is as strict and a stickler for manufacturing and expiry date protocol as the pharma industry. And not without reason because its efficacy and people’s lives depend on it. An excellent WMS can track products in the warehouse as per expiry dates and help optimize first-expired-first-out meds.

Temperature Maintenance – Quite often pharmaceuticals must be maintained at constant temperatures. Without a doubt, this must be integrated with a WMS rather than manual operations. Automating climate-controlling can reduce contamination, promptly identify, and inform refrigerator/freezer breakage, and at the same time, optimize energy usage.

Security Concerns – Yes, a good WMS gives you a clear stock of all the inventory at any time in your warehouse. It also details stock coming in and batches going out. However, where it similarly excels is in labeling and vendor tracking. This is of importance when managing spillage and possible theft too. For more information, visit https://www.pharmision.barcodeindia.com/blogs/robust-wms-re-shaping-the-future-of-pharmaceutical-supply-chain/

Digital Transformation in Pharma Manufacturing and its Benefits - BCI Pharmision

 

According to a KPMG study, companies in the life sciences industry have already recognized that digital transformation will lead to changing roles in the ecosystem. 85% of respondents see tech companies as the driving force of digitalization in their industry, and 63% see these companies as possible cooperation partners within the next year.

More than digitization’s far-reaching benefits, it has become a necessity in the pharma industry. The Food and Drug Administration (FDA) has made that quite clear through its guidelines. Companies need to eliminate the scope of human error in an industry where tolerances in precision and quality are nil. They must set up and adopt processes and SOPs to guarantee high-quality products.

Another reason why digitization is key to the life sciences industry is a certain emerging trend.

The new buzzword in the pharma industry is patient-centricity.

Many industry experts have the opinion that patient-centricity will be of prime importance in the coming years and digitalization is instrumental in this important step. In the same KPMG study, 17 percent of respondents named ‘patient-centricity’ as a current benefit of digitalization, while 24 percent believed this will be a key focus within the next 5 years.

But is digital transformation an absolute necessity? Let us find out…

The Problem with the Traditional Way of Functioning
One of the biggest challenges that pharma manufacturers with traditional setups often face are issues bridging the gaps between people and systems, people, and data, and even between groups of people. This affects manufacturing processes, performance, and even product quality.

These companies’ manual processes are slow, cumbersome, and prone to human error. This negatively impacts their ability to meet the good manufacturing practice (cGMP) guidelines. The most common issues faced by these organizations include, but are not limited to Inefficient processes, Illegible and inaccurate information, data integrity, disconnected systems, and human error. For more information, visit https://www.pharmision.barcodeindia.com/blogs/digital-transformation-in-pharma-manufacturing-and-its-benefits/

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/