Precision Stability Storage, LLC

RELIABLE ICH Q1A (R2) COMPLIANT STABILITY STORAGE

Precision Stability Storage takes pride in providing consistent, reliable storage conditions for companies seeking compliance with the ICH harmonised tripartite guidelines for stability testing of new drug substances and products Q1A(R2).

In order to research the quality of your new drug formulation, you need to be sure the storage units that you use for your testing are able to reliably approximate the climatic conditions for each of the four climatic zones.

Precision Stability Storage provides you with a capable, knowledgeable partner who can help you reach your goal of producing finished pharmaceutical products as efficiently as possible.

HIGH-QUALITY OFF-SITE STABILITY STORAGE

Precision Stability Storage provides off-site stability storage space for pharmaceutical products that require ICH specified environmental conditions. We offer the highest-quality equipment and facilities available for temperature and humidity control.

 All of our rooms meet or exceed ICH guidelines and have been mapped and validated for FDA mandated long and short-term shelf life studies under various temperature and humidity requirements. This includes intermediate testing and accelerated testing per ICH Q1A (R2).

 Our strategic partnership with Parameter Generation & Control allows us to offer Precision clients the highest-quality equipment and facilities available for environmental and humidity control for companies testing their new drug products.

 Precision takes a proactive approach to excursions, our monitoring system provides multi-level alarming with text and e-mail out notifications allowing us to address most would be excursions before they happen. Team communication determines mitigation solution and path forward.

 In the unlikely event of an excursion, our 21 car part 11 compliant equipment monitoring software provides an insight to the reason of excursion enabling us to minimize out of specification time. All excursions are addressed under Precision cGMP quality system.