Stability testing is a crucial step in drug development and production. Guidelines governed by The International Council for Harmonisation (ICH) determine how new pharmaceutical products must be tested for stability and quality prior to approval for worldwide distribution. Pharmaceutical companies and manufacturers closely adhere to these guidelines in order to properly gather qualified data on the development of drug products/drug substances, and to determine the necessary steps to move into the drug approval process.
Stability Testing Guidelines
The ICH of Technical Requirements for Pharmaceuticals for Human Use was established in 1990 to regulate the introduction of new drug substances worldwide. The specific stability testing and packaging protection that every new drug substance and drug product must undergo is outlined in ICH document Q1A (R2). ICH stability guidelines have been adopted on a broad international level by the European Union, U.S. FDA, and the Japanese Ministry of Health, Labor, and Welfare. These guidelines determine how the drug degrades over time in high temperature and high humidity conditions, representing various climates.
In accordance with the FDA, the purpose of stability testing is to determine how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature and humidity. Standard ICH conditions utilized in adherence with these guidelines are:
ICH Stability Zones for Long Term Testing
|
Climatic Zone |
Climate Type |
Conditions |
Min. Duration |
|
Zone I |
Temperate |
21°C/45%RH |
12 months |
|
Zone II |
Mediterranean/Subtropical |
25°C/60%RH |
12 months |
|
Zone III |
Hot, Dry |
30°C/35%RH |
12 months |
|
Zone IVa |
Hot Humid/ Tropical |
30°C/65%RH |
12 months |
|
Zone IVb |
Hot/ Higher Humidity |
30°C/75%RH |
12 months |
Stability testing involves determining how a product responds to conditions over an extended period of time. Conducting these studies is a time-consuming process and utilizes valuable company time, personnel, and space.
In order to free up valuable resources and allocate them towards more relevant purposes such as manufacturing and research, the logical conclusion for many companies is to outsource stability studies and storage. There are a number of benefits to outsourcing your stability study.
1. Have your study managed from ‘A to Z’
The right facility will manage your study and product as if it were their own, giving you the peace of mind only stability experts can provide. Not every GMP Storage/ Stability facility is created equally. In choosing the proper facility to entrust with your study and valuable product, you should ensure the GMP facility is equipped with the following:
- 24/7 Monitoring of your product. Make sure the facility has redundant monitoring of both temperature and humidity in its stability chambers to ensure your product remains at proper condition at all times. In the event of a temperature/condition excursion, it is imperative there is a proper 24/7 response to address any issues and to ensure that your product remains viable. Does the facility employ its own facilities team to respond to alarms? If not, they may be waiting days for repairs to their stability chambers while your product remains out of proper condition.
- 24/7 Security. Proper security is essential. How many employees have access to your product at the facility? How many cameras are on-site and are they monitored? A proper facility will be able to restrict and track access to all products 24/7.
- Backup Power. Storing your study with a facility that does not utilize multiple backup power systems and redundancies may leave you with costly product loss and time delays with your study. Generators should be utilized in the event of a power outage with the ability to run all operations of the entire facility, not just the stability chambers.
- The facility will be able to manage your study and adhere to your pull schedule including the need for weekend and off-hour pulls. Overall they should be flexible if your study protocols change and adapt in adherence with your study.
- Transportation. Solutions must be available that include working with your preferred carrier to ensure the safety of your valuable product at proper conditions with monitoring in transit.
- Also, make sure the facility you choose has extensive experience with stability studies. How long have they been in the industry? What is their reputation?
The facility should be transparent in all procedures and competently answer your questions. A fully GMP compliant facility will be prepared for audits for new/existing customers. The quality agreement should clearly outline expectations and responsibilities of each side. Outsourcing to a GMP facility that checks all the boxes will free up personnel and valuable space.
2. Free up valuable in-house storage space
In house storage space with CMO/ CDMO’s can be valuable and tight especially with time-consuming stability studies. A third party facility to store drug product/ drug samples is incredibly beneficial.This third party should be able to provide an overall wide range of ICH stability conditions for your study. An added benefit is a facility that can also provide custom stability conditions that may not be available at your facility.
Finding the proper facility to conduct your stability study is critical to patient safety and your success. Proper adherence to ICH guidelines at your chosen facility is essential to the overall integrity of your product reputation. Outsourcing with storage experts will alleviate the burdensome stability study process and leave you with confidence and peace of mind knowing your product is in capable hands.
About The Author
Carlin Bray
Product Manager, Masy BioServices
Carlin Bray is a Product Manager for Masy BioServices’s state of the art Biorepository and a SME on all things GMP Storage. She specializes in providing solutions for complex storage/stability projects for customers within the Biopharma/Biotech industry.