Long-term Stability Testing of Generic Drug

Long-term stability testing of generic product plays an important role in the drug re-evaluation procedure, which is carried out under the storage conditions specified by the Reference Listed Drugs (RLDs). Based on the requirement of the FDA, scientists perform the long-term stability research to investigate and demonstrate the efficacy and safety of the drug over a relatively long period of time. The registration and commercialization of generic drugs requires a stability research program. The FDA requires that when applying for the consistency evaluation of generic drug, the application materials must include 6 months of long-term stability data. Alfa Chemistry provides long-term stability testings to ensure your generic product quality and regulatory compliance. We provide the minimum amount of data needed for registration to minimize redundant testing, and help to reduce the time and cost.

Figure 1. Types of Stability Studies. (Aashigari, S.; et al. 2019)

Purpose of the Long-term Testing

• Accurately reflect the stability characteristics of product
• Used to determine the storage conditions of the product
• Predictive tools to establish product expiry

Our Long-term Testing Services

The results of the long-term stability studies are used to determine your products' expiration that are included in the stability section of the consistency evaluation.

• Long-term test conditions: 25°C ± 2°C /60% RH ± 5% RH
• At Alfa Chemistry, the frequency of testing is sufficient to deliver stability data of the drug product by determining whether any change can affect the efficiency of the final product over or involving a relatively long period of time
• Our long-term testing covers a duration of at least 12 months and at least three primary batches at the time of submission, which is sufficient to cover the recommended re-test period
• Upon request, we submit to the FDA additional data accumulated during the long-term stability assessment period of the application for registration
• If significant changes occur at any time during the testing period, we re-evaluate against these significant change criteria by conducting additional testing at the intermediate storage conditions and submit this data in the consistency evaluation

Alfa Chemistry's Scientific Long-term Testing Process

Our experts design a robust and science-based stability program, a strategy of conducting long-term stability studies on initial batches to expedite regulatory filings.

Protocol design

• Communicate with customers to clarify the focus of the stability research
• Flexibility on testing duration and conditions of testing

Stability research

• Determine the storage of samples according to each customer's protocol
• Monitoring of the testing progress and experimental calender upload

Data analysis

Analyze and submit data derived from final dose testing to drug regulatory authority

Our Advantages

• Complete sample management service: samples are well stored in environmentally controlled conditions to obtain accurate data
• In addition to ICH conditions, Alfa Chemistry offers custom conditions with options for storage from -80°C to +50°C with a full range of humidity control
• A team of highly experienced pharmaceutical industry experts who are well trained
• Accurate interpretation and application of relevant regulations
• Industry-leading facility: Tightly controlled temperatures and humidity rates during the testing, helping you store and manage any sample throughout the lifecycle of your stability program