Brian Curran, Senior Vice President of Strategic Growth, MasterControl10.14.20
Contract pharmaceutical manufacturers know demand is on the rise, but now more than ever is the time to prepare for considerable growth and change. A recent survey1 conducted by Accenture revealed that over the next three years, 91% of life sciences companies plan to increase their use of contract manufacturers. This surge of new business carries the promise of higher revenue, but it also brings unique challenges into sharp focus. To remain competitive in current economic conditions, the market demands that contract pharmaceutical manufacturers be agile, transparent and efficient. With the right cloud-based manufacturing solution, organizations are able to meet and exceed these expectations while gaining a competitive edge.
Scale and Adapt
Flexibility is key. Whether an organization needs to scale up to increase production capacity or to scale down to mix smaller batches, contract pharmaceutical manufacturers must be adaptable.
One of the biggest hindrances to agile operations is often self-imposed by manufacturers themselves: reliance on rigid, paper-based manufacturing processes. Many organizations hang on to this production method because they feel since it’s always worked, “Why change?” The reality is that paper doesn’t scale well and ultimately creates problems that reduce efficiencies along with profits. With increased production comes additional paper records, and the probability for error increases in an industry where mistakes impact lives.
Transitioning away from a familiar way of doing things can be uncomfortable, but as is the way with technology, there will be a point in time when companies that don’t adapt risk becoming obsolete. It’s happened enough times now that there is an abundance of cautionary tales to choose from.
Think of video rental stores that went out of business because they didn’t offer streaming services quickly enough or cell phone companies that ignored customer demands for better software. In both cases, there were businesses that went from dominating the market to facing bankruptcy. Paper-based manufacturing processes are the industry’s equivalent of the short-sightedness displayed by those businesses.
Contract pharmaceutical manufacturers that choose to digitize one of the last places such volume of paper exists will achieve rapid scalability, and those that don’t will inevitably fall behind. It’s like continuing to use dial-up internet in a world where wireless is the norm.
The right digital manufacturing solution is simple to implement, provides all the benefits of a computer-based system, yet feels extremely easy to use because its designed to look like the paper-based systems companies use today. This eliminates many of the problems with paper-based systems, and the efficiency gains are considerable.
Wellington Foods, a leading contract manufacturer of nutraceuticals, reached a point where their paper-based processes simply couldn’t scale. President and COO Tony Harnack explains “…as we’ve grown, and the volume of transactions has increased, the paper-based systems become harder and harder to manage.” They turned to a cloud-based solution that enabled them to go 100% paperless, implementing sophisticated tools without any investment in expensive hardware or custom programming.
Minimize Production Errors
It’s time to abandon error-prone, paper-based processes in favor of a digitized system that minimizes and eliminates production errors. When there is paper being used on the shop floor, it’s not uncommon for workers to write information in the wrong field or reverse numbers. Sometimes those entries are simply illegible. These mistakes then travel through the rest of the production cycle and cause significant and costly delays.
Errors like those described cause substantial problems with data integrity and traceability, which jeopardizes regulatory compliance. Last year, it was reported2 the FDA cited data integrity on 79% of the drug warning letters over the last five years, and they have increased the number of warning letters citing data integrity by over four times.
Both these problems can be remedied with electronic batch records. They empower a business to enforce data limits, so incorrect entries are automatically rejected and must be fixed before an operator can continue with next steps. Any entered information that is out of specification can be reviewed immediately. Because problems are fixed in real-time, quality is addressed and enforced right on the production line. Incorrect entries don’t have the opportunity to cause a ripple effect of bad data that cascades throughout the production process.
Electronic batch records3 ensure a high level of data integrity and make it possible to shorten review times and simplify compliance. Manufacturers who use them have seen improvements in critical areas. For example, a 503B compounding facility often found calculation mistakes during quality reviews. The calculations had to be reworked, and this took entirely too much time. Now their system performs complex calculations that are done right the first time, and the company’s operations are more efficient.
Provide Transparency
Manufacturers need transparency both inside and outside their organization, and without connectivity, nobody has the information they need.
Internal Transparency
Internal transparency is critical because work is more efficient when all operators have access to the same accurate, up-to-date information. This type of transparency is impossible with disparate systems and becomes problematic as well as impossible when companies operate multiple sites within the same country or around the globe.
Another company in the life sciences, with nearly 4,500 employees in different locations throughout the world was once operating from a legacy system almost old enough to vote. A big challenge of theirs was having to rely on a paper-based system with too many moving parts. They wanted employees at all locations to have access to the same information and follow a uniform process while using a minimal amount of hardware. Through digitization, the company now has a streamlined, modern solution that eliminates paper and allows employees to have access to the latest information as soon as they need it, from wherever they are in the world.
A common example of internal transparency issues that hits close to home for many manufacturers is the lack of communication between manufacturing and quality. Paper-based systems create the problem of making it appear as though the two departments have conflicting goals. Manufacturing wants to do their job quickly, and quality wants to ensure the work is done correctly. The truth is both departments work for the same organization and both are aiming for its success.
While paper-based processes divide these departments, digitization unites them. Quality and manufacturing both have access to the same information and understand how to accomplish their work while assisting the other department. Their goals no longer appear to be mutually exclusive, and they are able to work together to quickly produce a high-quality pharmaceutical product.
External Transparency
The issue of external transparency can be resolved in a similar way – transparency through a digital manufacturing solution that provides access to accurate and comprehensive data.
The increase in the number of customers turning to contract manufacturers is resulting in an increased number of customer audits. In the aforementioned Accenture survey, 67% of respondents said they had limited visibility and control over contract manufacturing and quality, and 78% wanted to improve collaboration within their quality management process.
To build trust with current and prospective customers, it’s necessary to provide access to real-time information so a customer always understands where their product is on the shop floor and when it will be completed. When an organization has a holistic view of their data, this information is simple to provide through real-time dashboards, and a contract manufacturer can easily explain how they are adhering to a brand owner’s product requirements. As Harnack says, “Our customers depend on us to have a system that works for them.”
Shorten Review Times
Many of the issues discussed here, such as poor data integrity and transparency through connectivity, are reasons that review times become drawn out. For example, without having a way to digitize and collect relevant data, it’s difficult to determine whether an issue will require a corrective and preventative action (CAPA). Having the ability to reduce deviations is a powerful way to reduce review times. Legacy Pharmaceutical Packaging tested a new digital tool with a risk-based approach to analyzing quality events and saw a 21% reduction in total deviations.
In addition, like Wellington Foods, the contract pharmaceutical packaging company utilized data input controls and automated workflow routing. Prior to digitization, quality reviews took 2-3 hours per batch record. With over 200 batch records, this cost valuable amounts of time. During their trial run with a new digital solution, Legacy Pharmaceutical Packaging was able to improve efficiency and reduce quality reviews to only 10-15 minutes per batch record.
Time to market is money, and no organization can afford to have product waiting on the shop floor while quality reviews take place. With the improvements made by adopting the right technology, Wellington Foods reduced its review period from 10-15 days to a mere three days – a 75-80% reduction. The gains Legacy Pharmaceutical Packaging and Wellington Foods experienced by shortening review times are significant.
Life sciences contract pharmaceutical manufacturers are sought out because they provide hard to attain GMP certified capabilities, but many still use paper on the shop floor. As the industry adapts to meet demand and consolidates to simplify supply chains, now is the time to digitize and do those things more efficiently. The ability to be flexible, provide high quality products and accelerate time to market are priorities because they are the most significant competitive differentiators. Some organizations may wait to digitize, which means there is a substantial opportunity to leverage technology and lead the competition. Contract pharmaceutical manufacturers or those looking to work with one should make the choice today – play catch up or get ahead of the curve.
Brian Curran is SVP of Strategic Growth at MasterControl. He joined the company in 2002 to direct and expand MasterControl’s product development efforts. He has more than 25 years of experience leading the direction for enterprise and entrepreneurial software development companies. Curran began his career with IBM, where he spent five years leading consulting engagements with Fortune 500 companies such as MCI, BellSouth, and many others. After this, he held several director- and vice president-level product management and marketing positions for entrepreneurial software development companies in the telecommunications and web analytics sector.
Scale and Adapt
Flexibility is key. Whether an organization needs to scale up to increase production capacity or to scale down to mix smaller batches, contract pharmaceutical manufacturers must be adaptable.
One of the biggest hindrances to agile operations is often self-imposed by manufacturers themselves: reliance on rigid, paper-based manufacturing processes. Many organizations hang on to this production method because they feel since it’s always worked, “Why change?” The reality is that paper doesn’t scale well and ultimately creates problems that reduce efficiencies along with profits. With increased production comes additional paper records, and the probability for error increases in an industry where mistakes impact lives.
Transitioning away from a familiar way of doing things can be uncomfortable, but as is the way with technology, there will be a point in time when companies that don’t adapt risk becoming obsolete. It’s happened enough times now that there is an abundance of cautionary tales to choose from.
Think of video rental stores that went out of business because they didn’t offer streaming services quickly enough or cell phone companies that ignored customer demands for better software. In both cases, there were businesses that went from dominating the market to facing bankruptcy. Paper-based manufacturing processes are the industry’s equivalent of the short-sightedness displayed by those businesses.
Contract pharmaceutical manufacturers that choose to digitize one of the last places such volume of paper exists will achieve rapid scalability, and those that don’t will inevitably fall behind. It’s like continuing to use dial-up internet in a world where wireless is the norm.
The right digital manufacturing solution is simple to implement, provides all the benefits of a computer-based system, yet feels extremely easy to use because its designed to look like the paper-based systems companies use today. This eliminates many of the problems with paper-based systems, and the efficiency gains are considerable.
Wellington Foods, a leading contract manufacturer of nutraceuticals, reached a point where their paper-based processes simply couldn’t scale. President and COO Tony Harnack explains “…as we’ve grown, and the volume of transactions has increased, the paper-based systems become harder and harder to manage.” They turned to a cloud-based solution that enabled them to go 100% paperless, implementing sophisticated tools without any investment in expensive hardware or custom programming.
Minimize Production Errors
It’s time to abandon error-prone, paper-based processes in favor of a digitized system that minimizes and eliminates production errors. When there is paper being used on the shop floor, it’s not uncommon for workers to write information in the wrong field or reverse numbers. Sometimes those entries are simply illegible. These mistakes then travel through the rest of the production cycle and cause significant and costly delays.
Errors like those described cause substantial problems with data integrity and traceability, which jeopardizes regulatory compliance. Last year, it was reported2 the FDA cited data integrity on 79% of the drug warning letters over the last five years, and they have increased the number of warning letters citing data integrity by over four times.
Both these problems can be remedied with electronic batch records. They empower a business to enforce data limits, so incorrect entries are automatically rejected and must be fixed before an operator can continue with next steps. Any entered information that is out of specification can be reviewed immediately. Because problems are fixed in real-time, quality is addressed and enforced right on the production line. Incorrect entries don’t have the opportunity to cause a ripple effect of bad data that cascades throughout the production process.
Electronic batch records3 ensure a high level of data integrity and make it possible to shorten review times and simplify compliance. Manufacturers who use them have seen improvements in critical areas. For example, a 503B compounding facility often found calculation mistakes during quality reviews. The calculations had to be reworked, and this took entirely too much time. Now their system performs complex calculations that are done right the first time, and the company’s operations are more efficient.
Provide Transparency
Manufacturers need transparency both inside and outside their organization, and without connectivity, nobody has the information they need.
Internal Transparency
Internal transparency is critical because work is more efficient when all operators have access to the same accurate, up-to-date information. This type of transparency is impossible with disparate systems and becomes problematic as well as impossible when companies operate multiple sites within the same country or around the globe.
Another company in the life sciences, with nearly 4,500 employees in different locations throughout the world was once operating from a legacy system almost old enough to vote. A big challenge of theirs was having to rely on a paper-based system with too many moving parts. They wanted employees at all locations to have access to the same information and follow a uniform process while using a minimal amount of hardware. Through digitization, the company now has a streamlined, modern solution that eliminates paper and allows employees to have access to the latest information as soon as they need it, from wherever they are in the world.
A common example of internal transparency issues that hits close to home for many manufacturers is the lack of communication between manufacturing and quality. Paper-based systems create the problem of making it appear as though the two departments have conflicting goals. Manufacturing wants to do their job quickly, and quality wants to ensure the work is done correctly. The truth is both departments work for the same organization and both are aiming for its success.
While paper-based processes divide these departments, digitization unites them. Quality and manufacturing both have access to the same information and understand how to accomplish their work while assisting the other department. Their goals no longer appear to be mutually exclusive, and they are able to work together to quickly produce a high-quality pharmaceutical product.
External Transparency
The issue of external transparency can be resolved in a similar way – transparency through a digital manufacturing solution that provides access to accurate and comprehensive data.
The increase in the number of customers turning to contract manufacturers is resulting in an increased number of customer audits. In the aforementioned Accenture survey, 67% of respondents said they had limited visibility and control over contract manufacturing and quality, and 78% wanted to improve collaboration within their quality management process.
To build trust with current and prospective customers, it’s necessary to provide access to real-time information so a customer always understands where their product is on the shop floor and when it will be completed. When an organization has a holistic view of their data, this information is simple to provide through real-time dashboards, and a contract manufacturer can easily explain how they are adhering to a brand owner’s product requirements. As Harnack says, “Our customers depend on us to have a system that works for them.”
Shorten Review Times
Many of the issues discussed here, such as poor data integrity and transparency through connectivity, are reasons that review times become drawn out. For example, without having a way to digitize and collect relevant data, it’s difficult to determine whether an issue will require a corrective and preventative action (CAPA). Having the ability to reduce deviations is a powerful way to reduce review times. Legacy Pharmaceutical Packaging tested a new digital tool with a risk-based approach to analyzing quality events and saw a 21% reduction in total deviations.
In addition, like Wellington Foods, the contract pharmaceutical packaging company utilized data input controls and automated workflow routing. Prior to digitization, quality reviews took 2-3 hours per batch record. With over 200 batch records, this cost valuable amounts of time. During their trial run with a new digital solution, Legacy Pharmaceutical Packaging was able to improve efficiency and reduce quality reviews to only 10-15 minutes per batch record.
Time to market is money, and no organization can afford to have product waiting on the shop floor while quality reviews take place. With the improvements made by adopting the right technology, Wellington Foods reduced its review period from 10-15 days to a mere three days – a 75-80% reduction. The gains Legacy Pharmaceutical Packaging and Wellington Foods experienced by shortening review times are significant.
Life sciences contract pharmaceutical manufacturers are sought out because they provide hard to attain GMP certified capabilities, but many still use paper on the shop floor. As the industry adapts to meet demand and consolidates to simplify supply chains, now is the time to digitize and do those things more efficiently. The ability to be flexible, provide high quality products and accelerate time to market are priorities because they are the most significant competitive differentiators. Some organizations may wait to digitize, which means there is a substantial opportunity to leverage technology and lead the competition. Contract pharmaceutical manufacturers or those looking to work with one should make the choice today – play catch up or get ahead of the curve.
- https://www.accenture.com/_acnmedia/pdf-98/accenture-life-sciences-dare-to-be-different-contract-manufacturing.pdf
- https://govzilla.com/blog/2019/05/pharma-medical-devices-data-integrity-breaking-down-keywords-and-citation-trends-from-the-fda/
- https://www.mastercontrol.com/manufacturing/batch-records/
Brian Curran is SVP of Strategic Growth at MasterControl. He joined the company in 2002 to direct and expand MasterControl’s product development efforts. He has more than 25 years of experience leading the direction for enterprise and entrepreneurial software development companies. Curran began his career with IBM, where he spent five years leading consulting engagements with Fortune 500 companies such as MCI, BellSouth, and many others. After this, he held several director- and vice president-level product management and marketing positions for entrepreneurial software development companies in the telecommunications and web analytics sector.
