In a recent article, we reviewed and discussed key components of cGMP and ISO 17025 quality systems and the role they play in the world of contract laboratory testing as it relates to pharmaceutical, biotechnology and medical device companies. As a follow up to that article, my interest was piqued with regard to where the industry stands when it comes to quality system certifications. Specifically, my interest lies in the area of medical device and package testing, because these are two areas that have seen tremendous growth in the amount of testing performed. As little as ten years ago, package testing was only performed as part of a complaint resolution procedure. Today, many of the leading pharma companies have extensive package test programs that are under the watchful eye of the FDA. Concurrently, medical device test programs have dramatically grown due to the technology advances of new and improved, unique product holding and delivery systems. While my research was not scientific, as it was only based upon an online review of various service providers that advertise for package or medical device testing services, it did lead me to develop a list of the three most important considerations one should evaluate when choosing a testing service partner.
- A Comprehensive FDA Regulated and Inspected Quality System.
In my review of numerous laboratories that promote Medical Device and Package testing services, I could only identify one that highlighted on their website that the facility was FDA registered and inspected. For this specific company, the web site dedicated an entire page to quality and listed their complete history of FDA inspections. While many of the other providers listed qualifications such as ISO and ISTA certifications, no other laboratories could be identified as being FDA regulated. Medical Devices and package systems manufactured that carry drug products are subject to FDA approval. While ISO certifications certainly show a commitment to quality, it is imperative that your FDA regulated products be tested under strict cGMP quality system guidelines as these are the standards the FDA will be enforcing.
- Choose a Testing Service Provider that Offers Multiple Levels of Service.
In today’s fast paced manufacturing environment, management of multiple suppliers that support your product can be a daunting task. The ability to apply the “one stop shop” approach to your outsourced testing needs can make management of the test program a much easier task to handle. In addition, with the complicated devices and package systems that are making their way to market, a variety of qualification test modalities may be applicable. For example, a system that required ISO 11607 testing may also require glass qualification testing for specific parts of the system as well as some form of functional testing for the device portion. Even more extreme would be a system that also houses some form of drug product. Working with a testing partner that can provide a complete test program to include ISO 11607, component qualification testing, functional testing, and even actual drug product qualification analysis under one “roof” would prove to be most ideal from a time and cost perspective.
- Work with Testing Service Providers that have Extensive Knowledge and Experience and Adhere to a Consultative Approach to Client Service.
When you submit your sterile barrier package system for ISO 11607 testing, you want to ensure that the laboratory has performed this testing before. The same concept applies to any qualification testing – you do not want to be the “first time” that the laboratory is performing your test. A strong knowledge base and bench top experience carry a lot of weight in laboratory testing. In addition, and perhaps more significant, is how the laboratory shares that knowledge and experience with you. Many of today’s package systems and medical devices are new and unique. Are the laboratory staff members able and willing to work with you in a consultative manner to help you identify potential test plans? Can they draw upon their previous experience to help you identify effective and efficient plans to meet the regulatory requirements? Can they provide ancillary services such as protocol writing, method development, and validation if required? Working with service providers that can meet these requirements can make your job much easier.
Even when time is of the essence due to marketing and manufacturing deadlines, or because of regulatory submission timelines, it is imperative that you take the extra step to evaluate and consider outsourcing partners that can provide more comprehensive services that enable you to concentrate on other sections of the product development process. The extra few days upfront may prove to save you from a high level of stress, aggravation, and wasted time on the back end.