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/

How Adopting an eLog Solution Helps with Regulatory Compliance

 

The pharmaceutical industry has zero tolerance when it comes to ensuring the quality of drug produced. The reason behind that is quite obvious, since even a slight deviation from the desired product can have devastating repercussions on a mass level.

The US Food and Drug Administration (FDA) has put in place certain regulatory guidelines that need to be adhered to in order to release a product into the market. In the 1990s, the regulatory body put in place a framework called ALCOA, that serves as a checklist to help with regulatory compliance. Shortly after that, FDA released a section known as 21 CFR Part 11, with the intent to help pharmaceutical companies maintain data integrity while utilizing modern technology, by ensuring all information verified through these systems check all the boxes for regulatory compliance.

Although these two frameworks were introduced in the 1990s, a quick scan of the 483s issued these days clearly points to the fact that several pharmaceutical companies struggle to meet FDA’s regulatory guidelines even today.

Most pharmaceuticals finding it difficult to adhere to FDA guidelines could benefit from solutions compliant with the aforementioned concepts and GMP. A simple way any pharma company can ensure regulatory compliance is by adopting a high-quality eLog solution.

What is an eLog?

Simply put, an eLog management solution digitizes your area and equipment logs, enabling you to verify or review them online.

It helps you capture data and details of a batch, people involved and time of an activity from an area/equipment as and when it happens, storing and preserving your logs electronically, which can be searched and retrieved at any time.

It also helps you organize your data and presents it in the form of reports that are easy to comprehend.

eLogs allow you to cut down on costs incurred in printing, storing and retaining documents and makes managing your audit easy. You can store your data securely, accessing it any time you wish to and it helps you become more sustainable by completely eliminating the use of paper.

How can an eLog solution help you with compliance? Let’s find out. For more information, Visit https://www.pharmision.barcodeindia.com/blogs/how-adopting-an-elog-solution-helps-with-regulatory-compliance/

Single Label: Replacing Traditional Methods Using Barcode Technology

 

Traditional pharmaceutical manufacturing is a complex process that involves applying multiple labels on containers to understand their status at any given point in time.

A label is applied on every material that comes in, which is subsequently replaced or additional labels applied at every stage of operations. The label affixed usually displays details of the type of material, the stage in which it is at, its approval status, the users handling it, timestamps, etc.

Once the item moves from one stage to another, a fresh label is applied to it, showing all pertinent details of the current stage.

The use of multiple labels at every stage, however, poses a bunch of problems. Here are some common problems with the multiple label approach:

Illegibility: The details are usually handwritten, so legibility is sometimes an issue. There might be occasions where what is written on a label is not clear, in which case, there is a lot of back and forth to cross-check the details.

Human error: Since the labels are manually entered and placed, there is always a chance of human error such as incorrect entries, missing entries/signatures, affixing wrong labels on a container, and even missing labels altogether at times, which can cause several drastic issues down the line.

High printing costs: At each new stage, a fresh label has to be printed for a set of containers. Now, at any given point in time, there might be hundreds of such items for which new labels are to be printed for each stage. That becomes cumbersome and involves lots of labels to be printed and increased usage of stationery and driving up printing costs.

The effort involved: In a traditional setup, the responsible person has to go to a printing station, get a fresh label printed, contents of which are to be verified by the person who prints, get a doer-and-checker sign-off, and apply them on each of the containers. And this process is repeated every time the status of the material changes (quarantine to sample test to release/rejected). Moreover, in a multiple-label setup, extra effort is needed in color coding the labels and ensuring the availability of ample stationery. It also entails locating the containers in the warehouse and bringing down containers placed at a height, applying labels and placing them back at times. This complicates the workflow, as there is a tremendous amount of effort required. For more details visit https://www.pharmision.barcodeindia.com/blogs/single-label-replacing-traditional-methods-using-barcode-technology/

All You Need to Know About ALCOA+

 

The pharmaceutical industry has a history of struggling with data management until the inception of the ALCOA+ 

framework. Its introduction has transformed the way data is recorded and managed today. In an industry where

there is little tolerance for errors and quality deviations, ALCOA+ has proved to be a boon by allowing the industry 

to integrate its data and achieve regulatory compliance.

What is ALCOA+?

ALCOA+ is a system that ensures data integrity in the pharmaceutical manufacturing industry. It is the 

brainchild of Food and Drug Administration (FDA) and its main aim is to integrate data and ensure data security.

Adopting ALCOA+ is essential for compliance to FDA guidelines and GMP practices.

Principles of ALCOA

ALCOA is an acronym that stands for
Attributable
Legible
Contemporaneous
Original
Accurate

The ‘+’ at the end of the word indicates the additional elements that are a part of the system, which are complete, 

consistent, enduring, and available.

In order to benefit from the system, it’s imperative that you have a thorough understanding of each element, which 

will enable you to implement the system successfully and reap its rewards.

So, let’s take a deep dive into the elements that form ALCOA+ and understand each one of them in depth.

Read more, Visit https://www.pharmision.barcodeindia.com/blogs/all-you-need-to-know-about-alcoa/

Why GMP is a Must for Pharmaceutical Industry

 

Every industry has its own set of challenges.

For some, ensuring a smooth supply chain is the topmost priority, while for others, the rate of manufacturing could be the most crucial aspect.

When it comes to the pharmaceutical industry, ensuring quality is at the top of that priority list. Maintaining good quality is not possible without a robust plan in place, a set of guidelines to adhere to and a foolproof audit plan.

That is where GMP comes in.

What is GMP?

GMP or Good manufacturing practice is a system that ensures that your products are being manufactured and tested in line with the required quality standards in line with industry best practices.

It is typically ensured through the effective use of a quality management system (QMS) and enables you to implement proper quality control and minimize risks.

Read More Visit https://www.pharmision.barcodeindia.com/blogs/why-gmp-is-a-must-for-pharmaceutical-industry/

Do You Know Principles of GMP for Pharma Industry

Because of the public health consequences of product quality, the pharmaceutical sector is one of the most strictly regulated industries. GMP for Pharma industry can increase productivity while maintaining high-quality standards by automating and optimizing essential operations like manufacturing and supply chain management. Quality control and regulatory standards are now included as standard features in life science ERP packages. 

GMP rules must be followed throughout the production process, from material manufacture to work environment and equipment to authorized employee training and personal hygiene. Each step of the manufacturing process must be meticulously documented in order to demonstrate that all protocols were followed to the letter. Furthermore, following Pharma GMP regulations is required for the commercialization of medications. 

Principles of GMP Guidelines 

Principle 1: Step By Step Written Procedures

To better comprehend the facility's workflows, all operating procedures and work instructions should be written down as standard operating procedures and made available to all staff. The processes should be written in a clear and logical manner so that they are simple to understand and follow. 

Principle 2: Follow Procedures

To maintain a controlled and consistent performance, it is vital that all SOPs and documented procedures are followed exactly as specified. 

Principle 3: Document Work

Documentation that is timely and correct serves as a record that aids in compliance and traceability. GMP for Pharma industry documents serves as the foundation for any investigation in the event of an error. 

Principle 4: Validate Work

Documentation of products, methods, and procedures allows for validation at each level of the manufacturing process. 

Principle 5: Incorporate productivity, quality, and safety into your facilities and equipment.

At all stages of production, the company's facility should be built and planned to reinforce the goals of quality, consistency, and error minimization. 

Principle 6: Maintain Facilities And Equipment

Monitoring the facility with appropriate documentation reduces any safety concerns and helps to avoid contamination and quality control problems. 

Principle 7: Explain, Develop, And Demonstrate Job Competency

Employee capacity building, including Pharma GMP theory and practice training as well as role-related training, is required. Appropriate training allows employees to demonstrate job expertise by creating high-quality, safe, and efficient goods. 

Principle 8: Make Cleanliness a Daily Habit

The protection of the product from contamination is ensured by incorporating cleanliness, proper hygiene, and a strict sanitization schedule. 

Principle 9: Build Quality Into The Product

Control components, manufacturing process controls, packaging, and labeling controls, and holding and distribution controls should all be in place at every stage of the product life cycle. These controls at various stages of production have an impact on the product's final quality. 

Principle 10: Conduct Compliance And Performance Audits

Conducting scheduled and periodic audits are the only way to determine how successfully GMP is being implemented. Internal audits can be done to guarantee GMP compliance, while external audits can be conducted by agencies like the FDA. 

Conclusion

Global regulatory organizations define GMP for Pharma industry as processes that ensure product quality requirements. The manufacturing process must assure that the product is safe, pure, and effective.