As everyone in the pharma world knows, stability testing is one of the most crucial steps in the development of new drug products.
Current Good Manufacturing Practice (GMP) for finished pharmaceuticals dictates very specific requirements around the expiration date of a drug product and requires quantifiable stability testing to assure the appropriateness of that date.
Looking closer, we see that the ICH guideline Q1A (R2) states: The purpose of stability testing is to provide evidence on the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or shelf life for the drug product and recommended storage conditions.
Taking that into account, as compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and are often far from simple. By performing a series of analyses, industry experts like QUINTA-ANALYTICA, who offer a wide range of storage conditions for both active substances and dosage forms, can use testing programs to accurately determine how long a product will maintain the properties and characteristics it possessed at the time of manufacture under said conditions.
With both the European Medicines Agency and FDA listing similar guidance on testing frequency, stress testing, selection of batches, storage conditions, and more, choosing an A-Z pharma testing partner such as Quinta who operate globally gives you a major advantage, especially given that this information is vital for regulatory approval.
Offering the following stability regimes:
- 25°C/60% RH, 2 rooms, area 40m2
- 30°C/65% RH, 1 room, area 16m2
- 30°C/75% RH, 1 room, area 16m2
- 40°C/75% RH, 2 rooms, area 32m2
- Photostability chambers
- Transport studies (freeze-thaw cycles)
- And other non-ICH conditions
Quinta operates over 100 such tests annually, all within the GMP framework, and should undoubtedly be your partner of choice for your next stability testing project.
Get in touch with us to learn more.
June 17, 2021