Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates® Inc., discusses tactics to ensure quality in a contract test laboratory.
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Q: I am a quality control (QC) manager of a contract test laboratory. I am going to be upgrading the laboratory and would like to know if you have any advice on how I should approach this activity?
A: Upgrading a laboratory is an exciting activity but it needs to be approached with a thoughtful, well-constructed plan that does not interrupt the business needs of your clients. You mentioned that you are a contract test laboratory, which would imply the products you test could include clinical trial material, final product dosage forms, and potentially, APIs. In addition, you might be performing final product release as well as stability testing. Regardless of the testing you are performing, the first step of this process should be to notify your clients of your intention to upgrade. This is important because some clients may not wish you to perform their analyses on new equipment. You will need to work with these clients closely to make sure you understand their concerns and that you address them before decommissioning any equipment used to analyze their materials.
The next step in the process is to take inventory of the equipment you have and start making some risk-based decisions on a project plan that will define what should be replaced, in what order, and what the requirements are for each. Regardless of which piece of equipment you decide to tackle first, there are several issues you must address with every replacement. If you are simply upgrading to a new piece of equipment to replace an aging piece of equipment (i.e., like for like), your requirements will be straightforward. If you are replacing an existing technology with a significant upgrade or different technology, a more comprehensive approach will be necessary. In all cases, you will need to make sure the current equipment is performing adequately and is still capable of generating reliable results.
Like-for-like equipment or new technology?
For a simple like-for-like replacement, you should perform installation qualifications (IQ) and operational qualifications (OQ) on the new equipment. The next step in the process would be to execute a performance qualification (PQ) and a comparison protocol to show the results obtained with the new equipment are the same as the results obtained with the old equipment. In many cases, the PQ and comparison may be combined into one document. If the results from the protocol match up, you can decommission the old equipment and start using the new equipment.
When changing from one type of technology to a different, more sensitive technology, there are more decisions that need to be considered. You need to work closely with your client on the specifics of their product so you can perform the transition with minimal disruption to their and your product flow. These more complex upgrades require a lot of upfront planning. As with the like-for-like replacement, you need to make sure the current equipment is operating appropriately. As before, you need to perform the IQ and PQ on the new equipment. It is in the PQ and comparison protocol where attention to detail will be crucial to execution. For instance, when changing from high-performance liquid chromatography (HPLC) to the more sensitive ultra-high pressure liquid chromatography (UHPLC), you need to be prepared to address the possibility that you could see some unknown peaks during the analysis. These peaks need to be identified and characterized before you can continue with the transfer. While this investigation is underway, you need to determine the suitability of the product for release and the potential impact these unknown peaks might have on the stability of the item being analyzed. If the method being converted is a US Pharmacopeial Convention (USP) method, you need to be sure that the new methodology generates results that are equivalent or better than the results obtained using the compendial method. The comparability protocol details will help you address the unforeseen circumstances should they occur during the execution of the protocol. The issues arising from the conversion of one method to a more sensitive method need to be fully addressed and explained before decommissioning the obsolete equipment.
There may be situations where you will need to maintain both the new and the old equipment operational at the same time. For instance, you may want to continue to monitor the stability of a product on the equipment the analysis was started on and not change to the new equipment until the last stability time point has been analyzed. In this case, you will want to maintain the old equipment while utilizing the new equipment for release and future stability monitoring. These situations need to be discussed with your client and included in the laboratory timeline for transitioning the laboratory.
The importance of training
Another important element of transitioning a contract test laboratory is making sure your analysts are properly trained on the new equipment while maintaining expertise on the old equipment until the transition is complete. Many companies selling analytical equipment have experts to perform the necessary training and to help address issues that may come up as the analysts become more familiar with the equipment. It is important for the laboratory and your clients that analysts are properly trained so they can deal more effectively with problems that occur during the transition period. The more training and familiarity the analysts have in running the new equipment, the less disruption there will be to operations.
When introducing new equipment and new methodologies to a laboratory, it is important to have a comprehensive implementation plan that discusses what equipment you will introduce, the timeline for the introduction of the equipment, how you will investigate unexpected analytical results during the transition, and how you will make sure your analysts are appropriately trained while causing minimal interruptions to operations and your clients.
Putting your plan down in writing and discussing it with your clients up front will save you a lot of time and minimize delays as you implement your plan.
Vol. 41, No. 6