Has the stress of your job in pharmaceutical quality control/assurance gotten worse due to ever-increasingly stringent regulations? For those of you who work with any analytical/lab or process instruments, you know that staying in compliance with global regulations has become burdensome in the past decade. Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the workflow as soon as possible; but to do so you need to know everything there is to know about equipment and instrument qualification.
In the overall pharmaceutical manufacturing process, you may be just one cog on the gear of productivity, but without some help, you could go from cog to clog very quickly.
Overlooking the Obvious
Instrument qualification regulations and guidelines from GMP, 21 CFR Part 11, GAMP 5, and USP<1058> are lengthy and detailed. They require you to collect all data about the instrument’s intended use and maintenance, which is an ongoing, time-consuming, and laborious process. But the rationale for having these regulations and guidelines is simple: analytical test results from unqualified instruments can be wrong or invalid, thereby compromising drug safety and efficacy. The consequences for not being in compliance are the nightmares that keep you up at night — inspections and fines.
So what are your options? You could beef up your internal regulatory and compliance staff, but the pharma mantra these days is to be as lean as possible. After all, that’s what has fueled the outsourcing trend.
One solution that is often overlooked is seeking assistance from the company that manufactured your instruments. Doing so is more like partnering than true outsourcing, and frankly, it makes sense. Why not go to the source: the company that had to adhere to all those guidelines and regulations when it was creating the instrument?
The Key Components of an Instrument Qualification & Validation Solution
Tackling the 4Qs (Table 1) on your own can be daunting both from labor and time standpoints. Even understanding the difference between the terms qualification and validation can be challenging. Qualification is often referred to as a condition or state of control that must be met in order to assure the validity and reliability of test results.
Validation is establishing documented evidence that provides a high degree of assurance that a particular process will consistently produce a product that meets its predetermined specifications and quality attributes.
Instrument qualification is a prerequisite for process validation. That’s why many pharmaceutical companies seek assistance from Anton Paar. Anton Paar understands your need for completely traceable results, and supports you with a qualification and validation package.
Anton Paar’s Pharma Qualification Package (PQP) aids you in achieving and maintaining the qualified status of your instrument. Not only does this service comply with all the necessary regulations, it follows the 4Q model, taking much of the burden of qualification and validation off of you.
This ultimately can help you decrease your R&D cycle time and speed up your time-to-market. For example, the PQP includes:
Training is approved, complete, and documented. The final summary report denotes all activities and test points have been completed successfully, and any exceptions have been appropriately resolved. Imagine a year or two or three later, when original validation team members have moved on to other positions. Leaders who approved the many protocols, reports, and change controls have transitioned to other duties. Links and references to documents that once seemed obvious and logical are now gray and difficult to follow. When probing questions arise, and they will, what do you do? The documentation must stand on its own. How is this accomplished? Wouldn’t it be great if one document did this? There actually is the traceability matrix.
The Importance of Traceability, Personnel Training, and Maintenance
The traceability matrix provides a way of linking relevant specifications to test points. It indicates relationships between requirements, tests, and procedures. Not only does this concept easily demonstrate relationships between specifications, risk analysis, IQ/OQ/PQ tests, and the procedures established to maintain the validated state of your instrument, but it can be easily followed by even the most novice individual in the pharma qualification world.
If there’s one key message to remember about instrument qualification and validation, it’s that this is an ongoing process.
During inspections, regulators regularly check whether employees are sufficiently trained on the instruments they operate. Unfortunately, employees come and go and so do instruments, which means you’re always going to be managing complicated and costly training programs. User training is an integral part of Anton Paar’s PQP process.
Taking advantage of this component of the PQP can help you save time, reduce overall training costs, and improve compliance over the life of an instrument. An instrument’s life cycle is more than commissioning and decommissioning. It is important to recognize that each one of these devices is subject to continuous change control throughout its working life.
For example, it may be necessary to add new modules to an instrument to expand its capabilities, or perhaps you have to update its software to work with a new process.
Care and maintenance of an instrument throughout its life cycle via scheduled service checks, calibrations, and safety checks is essential for optimal performance. By partnering with an instrument manufacturer during instrument qualification, you can ensure an instrument will function properly and operate in a regulatory-compliant manner during the course of its life.
For example, Anton Paar offers ongoing preventative maintenance, regular maintenance, recalibration, and retrospective qualification of older instruments. The company’s qualified service engineers can provide regular checks, calibrations, and adjustments using only certified test equipment. They also can provide emergency repair services.
It’s not going to get any easier to comply with the bevy of pharma regulations that currently exist or that are on the horizon. But qualifying and validating analytical/lab and process instruments does not have to be as big of a challenge when you partner with your instrument vendor for various services and programs.
For more on Anton Paar’s Pharmaceutical Instrument Qualification program, visit www.anton-paar.com.