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Expedited Medical Solutions from A to Z

Joanne Meloro Top Pharma Compliance

Expedited Medical Solutions from A to Z

In the past year alone, the advent of the COVID-19 pandemic has caused a surge in vaccine research, manufacturing and distribution, cell and gene therapy research, and other medical technologies. As the rate of innovation in medical science rises exponentially, the demand for continued development in the industries supporting them have also increased. As a result, today’s R&D and manufacturing requirements also demand efficient and novel delivery solutions that can meet this need for speed and flexibility.

The speed of change and advancements in the scientific processes have risen to the point that many biopharma companies and other organizations that support them find it hard to keep up with the pace. This is where many pharma- and biopharma clients enlist the aid of IPS-Integrated Project Services (IPS)—an Engineering, Procurement, Construction Management and Validation (EPCMV) solution provider—to keep up with the growing demand for flexible and efficient solutions that support development of new and innovative drug products and delivery methods. As IPS’ Director of Strategic Initiatives, Joanne Meloro, puts it, “The biopharma drug manufacturers are responding to the human need for novel techniques, vaccines and other ways to address disease. So, in turn, those of us who serve that industry need to respond with different innovations, to address that need for speed, in a fast and prompt way.”

Founded in 1989, IPS is an EPCMV service provider that incorporates the complete project life cycle in its business process to present the optimum innovative solution to a client’s requirement. “It incorporates the complete project life cycle of its business process to present the optimum innovative solution to our clients’ requirements,” adds Meloro. Along with EPCMV, the company also has a competent and robust Commissioning, Qualification, and Validation (CQV) compliance division that efficiently caters to the clients’ compliance needs. From the CQV perspective, the company is constantly seeking out and developing different technologies that can help speed up the drug production process.

The company prides itself on its customer-centric operations and conducts thorough interactions to chart the ideal course to answer client needs. In the first conversation with the client, IPS listens to what they have to say and then ensures full clarification of the client’s regulatory requirements, from which a validation master plan is developed. The plan lays out the strategy for commissioning, qualification, and validation for their facility and processes and also instructs the client on how they achieve and maintain the validated state after the project is turned over to them. Next, a risk assessment based on the facility design and product manufacturing process is conducted. A successful risk assessment aims to identify and mitigate potential risks to patient safety, thereby producing safe and effective drugs. IPS will look at the project design elements and assign a risk level to them. Plans are then developed to mitigate those risks by either design engineering solutions or procedural controls. IPS plans for commissioning checklists and qualification protocols to test and verify that the facility design, utility, and process equipment installed conform to the client’s initial requirements. Following the execution of the commissioning, qualification, and validation protocols, summary reports are filed to provide evidence and ensure that the client agrees with the entire product development process.

To further increase the drive toward excellence, IPS recently launched a program known as IPS 4.0 as its global goals initiative for 2021. In it, the company identified five critical areas that it wishes to put forward as the focus for this year:

  1. Safety: IPS has a program known as Mission Zero Safety to ensure a safe and healthy culture for all project sites, global IPS offices, and employees.
  2. Growth: It has set the goal of reaching out to even more clients and delivering the best of services, marching toward extraordinary quality and success.
  3. Technology and Innovation: IPS continually explores and advances the implementation of innovative solutions in its business operations.
  4. Organizational Development: It is looking to execute its work without boundaries as a global organization.
  5. Client Focus: IPS’ client-focused organizational culture is based on two interconnected levels – mindset and behavior, allowing us to act in the best interest of our clients and increase their satisfaction.

An additional solution to meet the need for flexibility and innovation has been IPS’ current implementation of developing and executing regulatory compliant documents in a paperless fashion. To achieve this goal, IPS has engaged with several companies that provide licensed software platforms which are fully compliant with FDA, EU and WHO requirements, to provide maximum efficiency in CQV electronic document development, execution, approval, management, and control. This innovative streak is inherent in IPS, something Meloro credits to the IPS employees and their ability to provide quick and efficient solutions to their clients. The company employs many engineers and consultants formerly from pharma and biotech manufacturing companies, which equips IPS to better understand clients’ requirements to develop a solution and act accordingly.

Over time, IPS has evolved in its capabilities and has expanded its presence to other countries like Eastern and Western Europe, Asia, Singapore, China, Japan, Brazil, and India. IPS’ current focus is on building stronger relationships with its clients by understanding their challenges and developing better solutions. The IPS 4.0 initiative will also propel the company to reach unprecedented heights in the pharma/bio services market. 

This article originally appeared on Pharma Tech Outlook.

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