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.....

Source Link:-  https://www.pharmision.barcodeindia.com/blogs/digitizing-shop-floor-operations-for-pharma-manufacturing-excellence/

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....

Source Link:- https://www.pharmision.barcodeindia.com/blogs/3-ways-to-increase-productivity-and-quality-in-pharmaceutical-manufacturing/

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/