Part 7 — How Does the FDA's Process Validation Guidance Simplify a Technology Transfer?

Posted by Norm Fong

Technology Transfer: Want To Get It Right? 

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 7 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

The technology transfer of a process, whether it is from R&D to commercial manufacturing or from one manufacturing site to another, is a critical step in the life cycle of any drug product. To ensure your manufacturing site is doing what it should, it will help you to become familiar with the FDA’s process validation (PV) guidance, issued in January 2011, which defines three major stages that must be satisfied to consider a manufacturing process valid.

Under the FDA’s previous guidance issued in 1987, process validation was established through sampling and testing. Under the new guidance, the validation process is considered as an exercise in design and control. Here are the three distinct stages that make up the new definition of process validation:

1

Process design: The commercial manufacturing process is based on knowledge gained through development and scale-up activities.

2

Process qualification: The process design is evaluated to determine if the process is capable of reproducible commerical manufacturing.

3

Continuing process verification: Ongoing assurance that the process remains in a state of control is gained during routine production.

 

IQ, OQ and PQ Are Important

Assessment Qualification with a CMO PartnerBecause the process validation guidance pertains to equipment, three acronyms are commonly used: IQ, OQ and PQ. IQ stands for installation qualification, OQ is operational qualification and PQ is performance qualification.

If you, your manufacturing site or your contract manufacturing organization is acquiring a new piece of equipment, you’ll need design specifications that comprehensively define that piece of equipment, including everything from the type of power required to the exact materials used in its construction. Once you have your approved design specs, you can begin developing your IQ and OQ.

Installation Qualification (IQ)

For installation qualification, you must look first at the equipment material. For example, if you specified 316 stainless, you should test to verify it is in fact 316 stainless when it is delivered. Sometimes stainless steel is passivated to render the surface less reactive chemically and a test to verify there are no further residues from the passivation process may also be required.

If you specified a 5-force power motor in your equipment, you’ll want to ensure it’s a 5-force power motor. You’ll also want to confirm that the power requirements and power output are consistent with your specifications, and that the room the equipment is installed in can accommodate that power source.

Operational Qualification (OQ)

The next phase is operational qualification. At this stage, if you’ve specified that your equipment is going to run in a range of 50-150 RPM and will draw a specific amount of power, you want to verify that the equipment is achieving those operational requirements. Review those parameters and challenge them to make sure your equipment actually runs the way it’s supposed to run.

Performance Qualification (PQ)

In the final stage — performance qualification — you will challenge the equipment under load. While your equipment may run at 50 RPM or 150 RPM when it’s empty, you need to verify that it can still achieve appropriate speed ranges when there’s 300 kilos of material in it.

Once you’ve completed these three phases, the equipment is available for use in whatever process you intended for it.

Why Validation Matters

Validation is a method of documenting evidence that you have a high degree of assurance that your manufacturing process will consistently yield a product of predetermined quality. If this is unachievable or unsustainable, the results can be disastrous, costing you significant amounts of money, increasing the risk of product recall and potentially contributing to a loss of market share. At WellSpring, we prevent this through an effective change control process and by accounting for change in our day-to-day operations.

Occasionally, clients will ask us to manufacture a product using equipment they provide. In these cases, the IQ, OQ and PQ process becomes vitally important. We help clients specify the equipment they need and then quickly and efficiently bring that equipment in, install it, set it up and get it ready to go. The way we run the IQ, OQ and PQ process expedites the transfer of a product into our facility and ensures its performance within established parameters.

Read the Entire Tech Transfer Series

This blog post concludes our 7-part series on getting contract pharmaceutical manufacturing technology transfer right. We hope that you’ve been able to follow along and learn the fundamental elements that form a technology transfer, the issues that tend to arise and the solutions to ensure your process is effective and beneficial for your development and manufacturing program. Read the entire series:

Part 1 — What is a Technology Transfer and How to Ensure a Successful Transfer

Part 2 — The Ins & Outs of Technology Transfer

Part 3 — The Role of Project Management to Ensure a Smooth Technology Transfer

Part 4 — How Are Analytical Methods Exchanged in a Technology Transfer?

Part 5 — The Cost of Getting a Technology Transfer Right

Part 6 — In-Licensing Pharmaceutical Products: Due Diligence Can Help You Perform a Technology Transfer Successfully

Part 7 — How Does the FDA’s Process Validation Guidance Simplify a Technology Transfer?

Are you Facing Challenges of Scaling Up Production? Get a Free Consultation ►►

Topics: process validation, PV, FDA guidance, qualification, IQ, OQ, PQ

Norm is the technical transfer manager, business development, for WellSpring. He has over 21 years in the pharmaceutical manufacturing industry and has held development, transfer and commercial manufacturing positions over the course of his career with Patheon, Global Pharm (formally Pharmacia Upjohn) and Genpharm (owned by Merck). Norm is responsible for overseeing technology transfer and all validation activities in the organization.

About The Author