High-Quality Drug Products

Fagron Sterile Services US (FSS) is a 503B Outsourcing Provider vertically integrated with Fagron, a leader in personalizing medicine with a global reach of over 60 countries.  One way Fagron supports pharmacists is by supplying reliable high-quality bases, creams, and active pharmaceutical ingredients used to compound preparations for patients who cannot tolerate medications that are normally commercially available. Fagron businesses also manufacture sterile anesthesia, ophthalmic, and pain management medications, including compounded drug products that may be in short supply for reasons such as disasters, spikes in demand, or other supply-chain disruptions.

503B Outsourcing facilities (occasionally called 503B pharmacies or 503B compounders) specifically play an integral role in the large-batch supply of medications to hospital systems, ambulatory surgery centers, and other healthcare facilities. Per parts 210 and 211 of Title 21 of the Code of Federal Regulations (CFR), these specialized organizations are bound by Current Good Manufacturing Practices (cGMP). [1,2] FSS is able to produce product with  cGMP compliant operations and meet other regulatory requirements with a fully integrated Quality Management System called MasterControl. [3]

In this post, subject matter experts at Fagron Sterile Services and MasterControl detail how they have harnessed the power of MasterControl digital technology. The result of this partnership is the ability to bring life-changing drug products to more customers quickly and efficiently. [4]

Why Compounding is Important

Personalized Medicine

503B outsourcing facilities play an extremely important role in the continuum of patient care.

“Not everyone can take what is widely available behind the pharmacy counter, or over-the-counter; so they need something custom-made, tailored for them, and that’s where we come in.”
- Matt Seitz-Paquette, Fagron – North America Quality Specialist.

The value of personalized medicine is also emphasized by United States Pharmacopeia (USP) Chapter <797>. For many patients, compounded medications offer the only option for effective disease management. In particular, compounded medications are extremely beneficial for those who have allergies, rare diseases, or need altered dosage levels (such as pediatric patient). [8]</797>

Rapid Response to Patient Needs

[9] It is common for the supply and demand of pharmaceutical medications to rise and fall suddenly. When demand for certain medications rise however, it could be a matter of life or death for patients.  

At no time is the issue of drug shortages more apparent than during the current COVID-19 crisis. Dexamethasone, for example, a drug that Fagron compounds, is used to treat patients suffering from this potentially deadly virus. Therefore, 503B outsourcing facilities like Fagron Sterile Services are playing a “front-and-center” role in supplying these critical medications to hospitals and other healthcare entities.

In order to fit the needs of all patients and to respond expediently to spikes in demand, a robust quality management system must be firmly in place. MasterControl provides the perfect digital infrastructure for Fagron to streamline its quality system on a global level.   

What is MasterControl?

MasterControl is a cloud-based digitized Quality Management System (QMS) that empowers users to play a critical role in making medications available for patients while still maintaining compliance with the FDA and other regulatory agencies. This sophisticated yet easy-to-use technology accommodates the challenges associated with geographically dispersed work units, vendors, and contractors. Additionally, it allows staff to obtain and review documents simply by accessing them through the computer system rather than having to sift through paper records in distant file rooms. [5, 6]

Fagron Sterile Services chose to partner with MasterControl because of the shared commitment to Quality:

“If you look at our brand, you’ll notice that there are nine dots that represent our core values. At the center of those 9 dots is quality. We believe that quality intersects everything that we do.” Jason McGuire, Global Quality Director, Fagron Sterile Services

With the digitization and extensibility offered by MasterControl, the goal of intersecting quality into all aspects of manufacturing operations is achieved on a global scale. [7] The ultimate beneficiaries are (first and foremost), the patient; and also the healthcare systems that are tasked with providing high-quality, cost-effective medical care.

8 Characteristics of a Top-Tier Quality Management System

[10] MasterControl has designed its cloud-based QMS in such a way that it enables customers to incorporate functions at its own pace, and to fit its own distinct needs. The QMS harmonizes around 8 overarching principles.

  • Configurability: Versatility in making quality processes consistent throughout all worksites. This was a very important feature to Fagron, as the company must comply with cGMP in multiple regulatory environments, including the FDA (US), the European Commission, and ANVISA [Agencia Nacional de Vigilancia Sanitaria] in Brazil.
  • Modularity: Allows organizations flexibility to incorporate functions (e.g. documents, training) that fit specific needs of different work units.
  • Risk-based: Organizes functions so that employees can focus energies on higher priorities while still keeping track of lower-risk events.
  • Accelerator: Because it is cloud-based, the MasterControl solution can be launched quickly and seamlessly.
  • Easing Validation Burden:  Accomplishes FDA-compliant validations within hours (as opposed to months).
  • Personalization of Roles: Customizes information flow, making sure the right people get the right data at the right time.
  • Adaptability: Easily accommodates changes in regulatory requirements.
  • Facilitates business growth: As a business grows, QMS is geared toward meeting and exceeding ever-changing challenges and objectives.  

All of the above functions contribute greatly to the ultimate benefit of delivering medications to patients quickly and cost-effectively. It has been a transformative change for Fagron executives as well as front-line employees.

Taking Ownership of Continuous Improvement

When employees have the opportunity of working with a QMS that helps them to improve individual performance and have a positive impact on their company, they work harder and enjoy themselves while doing so. MasterControl’s automated systems check for content, signatures, and other benchmarks, ensuring that quality assurance requirements are met prior to moving drug products to the next stage of manufacturing.11  

“Working with electronic documents allows us to eliminate errors that happen when working with paper documents; especially if the system does not allow us to proceed further unless the document is correctly filled out.” Elzbieta Betkowska-Ozog

Since Fagron has partnered with MasterControl, there has been a dramatic increase in right first-time accomplishments.  The Role Personalization function prevents employees from getting over-burdened with data and information that is unrelated to their own responsibilities. Not only does this save time and frustration, but it also fosters a sense of personal agency and empowerment. The interconnectedness and coordination between different work units, whether down the hall or on another continent, demonstrates that they are not just individuals working in separate silos, but part of a much bigger picture: excellent patient care on a global scale. [12, 13]

Matt Seitz-Paquette, North America Quality Specialist for Fagron notes that since the launch of MasterControl, employees have increased their tendency to embrace quality assurance as a shared value and responsibility. When all employees, from the leadership to front-line lab technicians can adopt this core value, excellence is inevitable. [14]

Unifying the Expanding Ecosystem

[15] Matt Lowe of MasterControl describes the challenges of managing contractors, vendors, and suppliers in the “expanding ecosystem.” He states that companies very rarely keep all work tasks in-house. The challenges of the expanding ecosystem in the pharmaceutical industry carry an especially heavy weight, as poor alignment of quality processes can have grave medical consequences. This is why 503B Outsourcing Facilities and other healthcare organizations need to adopt a QMS that coordinates and unifies all work units. There are numerous positive outcomes associated with digitally automating and streamlining quality processes:

  • Integrate and automate: bringing together functions and work units.
  • Data accessibility: collaboration and analysis from any location.
  • Training accuracy: accessing status of progress on training.
  • Greater flexibility: pivoting business needs quickly and efficiently.
  • Greater control: instant knowledge of productivity and quality status in all departments.   
  • Greater transparency: being on the “same page” across business units.
  • Global quality alignment: harmonizing systems for consistent procedures.

Fagron Sterile Services - Quality Management Systems

In a true spirit of continuous improvement, Fagron Sterile Services has established a collaborative partnership with MasterControl for their Quality Management Systems. This enterprise has enhanced the ability of FSS to provide personalized medicines with safety, efficiency, and expedience. Since the COVID-19 crisis, Fagron has played a central role in adapting to sudden spikes in demand for certain medications, without giving in on the Core Value of Quality.

All employees at Fagron, including quality assurance managers, pharmacists, and lab technicians have fully embraced a QMS. The cloud-based system saves time, frustration, and endless reams of paper. It is configurable to meet the varying needs of different work units. In addition, MasterControl QMS can be rolled out as quickly or slowly as the intended users need. The partnership truly exemplifies the Fagron Central Core Value of Quality.

Fagron Sterile Services US (FSS) is a 503B Outsourcing Facility that specializes in high-quality compounded sterile preparations for acute care hospitals, ambulatory surgery centers (ASC), and clinics. FSS is known for reliability of supply, compliance, and quality and holds an excellent reputation in the industry.

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References:

1 Code of Federal Regulations:  TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C--DRUGS: GENERAL-PART 210 -- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL. [Current as of December 1, 2020).

2 Code of Federal Regulations:  CFR Part 211.  TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER C--DRUGS: GENERAL -  PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS. [Current as of April 1, 2019].

3 Fagron Sterile Services (2019, November 5). Fagron Uses MasterControl's Quality Management for their Personalized Medicine. [Youtube Video].

4 Ibid.

5 MasterControl. (2020, July 15). The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation. (Webinar).

6 Fagron Sterile Services (2019, November 5). Fagron Uses MasterControl's Quality Management for their Personalized Medicine. [Youtube Video]. 

7 MasterControl. (2020, July 15). The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation. (Webinar).

8 United States Pharmacopeia. (n.d.) General Chapter 797 Pharmaceutical Compounding - Sterile Preparations. United States Pharmacopeia. Retrieved from: https:// www.usp.org/compounding/general-chapter-797.

9 MasterControl. (2020, July 15). The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation. (Webinar).

10 Ibid.

11 Fagron Sterile Services (2019, November 5). Fagron Uses MasterControl's Quality Management for their Personalized Medicine. [Youtube Video].

12 MasterControl. (2020, July 15). The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation. (Webinar).

13 Master Control. ( 2019, November 5 ). MasterControl Regulatory Excellence.

14 MasterControl. (2020, July 15). The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation. (Webinar).

15Ibid.


References

Sean Jones, MBA
Senior Director of Marketing at Fagron North America, with more than a decade of experience in the pharmaceutical and healthcare industries.