Beyond the regulatory requirements surrounding pharmaceutical equipment validation, ensuring that pharmaceutical measuring equipment consistently performs as expected is critical for the safety and quality of your drug product. Equally important is the creation of documentation that proves the equipment validation was performed and all standards have been met. However, creating the documentation package during validation requires a considerable amount of time and internal resources, both of which are not always available as companies work to get ahead in today’s increasingly competitive industry. In addition, even the smallest error or misuse of laboratory equipment can lead to costly penalties for a pharmaceutical manufacturer, making expert guidance throughout the qualification process integral to the successful operation of your new equipment
While using a consultant to perform these tasks could alleviate your experts from having to do it themselves, you still face the risks and costs associated with paying someone outside your company to carry the weight of this critical task. Some manufacturers may even find themselves weighing the benefits of updating and/or improving existing laboratory instrumentation against the timely and costly requirements associated with equipment qualification and validation. Instrument providers can help their customers alleviate the burden of these activities but not all offer it as part of their installation qualification services.
In this article find out what should you be aware of as you consider your approach to equipment validation as well as what an instrument provider can do to help you avoid the hidden costs of GMP qualification.