Digital Transformation Fuels Growth at Pine Pharmaceuticals

As one of the first compounding facilities in the U.S. to be registered as a 503B facility, Pine Pharmaceuticals is an established, valued partner to health care providers across the country. The company supplies more than 50 affordable, high-quality, ready-to-administer compounds and repackaged products. They initially focused on the ophthalmology industry and have since expanded their portfolio to include pre-packaged IV solutions and injections for specialty practices, ambulatory surgery centers, and hospitals.

As Pine Pharmaceuticals celebrates their 10-year anniversary, they celebrate a decade of growth that has been achieved without ever sacrificing quality in their production processes. What started as a 5,000-square-foot manufacturing facility in 2014 has grown into a 75,000-square-foot facility, significantly increasing production lines, testing, and more.

“When I started there were maybe 15 of us here, and now we’re over 200,” said Jim Ando, Pharm.D., manager of innovation and development at Pine Pharmaceuticals. “We’re continually expanding our facilities and bringing on new people, bringing on new products and processes.”

Digitizing Quality to Enable Scale

With many moving parts across departments, a single source of truth helps to simplify and standardize processes and procedures. Since implementing MasterControl’s enterprise quality management system (QMS), Pine Pharmaceuticals exceeds the regulatory standards and compliance their pharmaceutical partners need and expect.

“MasterControl allows us to have a one-stop shop, where we’re able to have everything in one location,” said Gayle Gleason, Pine Pharmaceuticals director of quality. “We’re able to have our investigations, our procedures, our protocols, our training all in one area, and it makes it very convenient. It’s not paper-based; it has good documentation practices, so it all works together to give us that quality package, to give us that quality release of a product.”

Gleason acknowledges that everyone who has a hand in production uses MasterControl’s QMS to ensure all procedures are meeting the quality needs of their customers with proper training records and documentation, all digitally available in a single place. MasterControl makes it easy to collaboratively launch investigations and see data and trends over time across investigations, streamlining the identification of root causes and optimizing corrective actions.

Multiple Connected Departments. One Connected Platform.

Following the successful cross-department adoption of the QMS, implementing MasterControl’s electronic production records was a natural progression to remove paper processes throughout the company. The digitization of production records also allow Pine Pharmaceuticals to further scale their production by eliminating nearly all variability from their processes and realizing the benefits of automation, calculations, and review-by-exception.

“After working with the QMS, it became apparent that the batch record was a huge part of our paper process that we couldn’t necessarily digitize with the QMS. As soon as we saw that MasterControl had an electronic batch record feature available, we started to look into it right away,” Ando said.

Implementing the MasterControl electronic batch record (EBR) solution meant true organizational connectivity. The Pine Pharmaceuticals team could now integrate their EBR and QMS – no outside integration needed.

“From a regulatory standpoint alone, being able to have a nonconformance or a quality event linked directly to a batch record is extremely helpful. Everything is in one spot when our batch release team is preparing a drug to release,” said Allison Gentile, Pharm.D., director of pharmacy services and regulatory affairs.

Bringing Teams Together with MasterControl

After building their reputation on quality compounded pharmaceutical products for over 10 years, Pine Pharmaceuticals recently had the opportunity for a strategic integration with another local 503B facility. Expanding a compounding manufacturing facility is complex. New products, new employees, new processes, new equipment, and new ways of working all needed to be seamlessly integrated into their existing organization. And it all had to happen without interrupting production or compromising quality. Luckily, both companies had already implemented MasterControl. This meant that document ID numbers, standard operating procedures (SOPs), production records, policies, data, product requirements, and more could all be immediately ingested into MasterControl, making that process seamless and controlled.

“It really worked out well because they were using MasterControl, and we were using MasterControl,” said Muto. “It was like speaking the same language. It was just one barrier we didn’t have to overcome during that process. It made it a lot smoother.”

“Digitization and moving from paper to electronic-based systems for as much as we can is important for our innovation.”

A Continued Focus on Innovation

Pine Pharmaceuticals is committed to an ongoing investment in digitization, automation, and innovation across the product lifecycle to advance patient care. They’re always looking to improve processes with the right tech solutions.

The company’s next big area of focus is digitizing their paper logbooks with MasterControl, since managing 200+ logbooks throughout their facility can be overwhelming. With MasterControl electronic logbook software, Pine Pharmaceuticals removes the hurdles of misplaced logs or illegible entries. They also gain the ability to easily track, review, and find trends in their logbook data.

“[Logbooks are] easy for operators to use. They’ve got the information they need right there on their tablet. They’re putting all the information in that goes to quality personnel instantaneously. They look it over, they can make the approvals that are necessary, and you don’t have people running around chasing logbooks or wondering if they’re filled out correctly,” said Brent Standage, Pine Pharmaceuticals director of production operations.

Pine Pharmaceuticals employees recognize that by continuing to push the envelope with innovations – whether that’s with product development, manufacturing and production, or new technology implementation and digitization – it will help them better serve the patient who receives that life-changing treatment.