ICH-Recommended Stability Tests

Proper storage guidelines ensure that pharmaceutical products do not experience degradation events that could influence product safety and efficacy. For quality preservation, pharmaceutical products are required to bear a statement specifically outlining proper storage conditions. Regulatory agencies require product storage recommendations to be based on prior stability evaluations. Stability testing provides a reliable method for evaluating how the quality of a pharmaceutical product may change over time and under the influence of temperature, humidity, and light. In this way, stability testing helps to provide recommended storage conditions for a product as well as a designated retest period for quality control evaluations.

Stability testing should be carried out with validated analytical procedures and cover relevant physical, chemical and biological attributes as applicable to the product(s) under evaluation. ICH Stability Testing Guidelines take the diverse climates of Europe, Japan and the United States and, as such, have been harmonized to provide appropriate testing recommendations for all three markets. Following stability testing recommendations according to ICH recommendations yields stability testing and storage labeling that agree with European, Japanese and United States regulatory requirements.

Our Stability Testing Capabilities

CPT Labs has over 40 years of experience in consumer product testing and regulatory compliance evaluations for multiple industries including, but not limited to: pharmaceuticals, OTC drugs, consumer healthcare products, cosmetic and personal care products, specialty chemical, and medical device industries. Our seasoned analytical specialists are highly knowledgeable in validated, product quality evaluation methods and regulatory stability requirements.

CPT Labs performs stability testing evaluations according to the guidelines outlined by ICH.

Critical Stability Testing Considerations

Pharmaceutical products should be evaluated under storage conditions that test product sensitivity to temperature and moisture (when applicable). Precise conditions of testing storage conditions and testing duration should cover intended storage, shipment, and use conditions for final market products. Analytical assessment of product degradation species during stability testing procedures can be useful for determining degradation pathways and analytical procedure validation. Should degradation products not form during accelerated or long-term storage testing conditions, further analytical assessment for degradation products is not necessary. As a whole, ICH Stability Testing Guidelines outline several key considerations to satisfy stability testing requirements set by regulatory agencies.

Three of the key considerations of stability testing parameters are outlined below:

1. Batch Testing

Stability testing is required to be performed on the first three batches of a product at minimum. These batches should be manufactured on a pilot scale using the same production procedures intended for final product manufacture. Stability testing should also be conducted with products packaged in their intended final market container closure system to best simulate real-world conditions. Following these guidelines ensures that the product quality under assessment matches the quality of the intended final product.

2. Stability Testing Parameters

Stability testing identifies the overall product stability and likely degradation products that arise over time and in various environmental conditions. Testing procedures are adapted to the particular product (i.e., active ingredients and product type) under evaluation. Stability testing assesses the effect of temperatures (typically at their intended storage temperatures for long-term storage and higher temperatures for accelerated storage evaluations), humidity, oxidation, hydrolysis and photolysis on product stability.

3. Test Frequency

Product testing frequency should cover the stability profile of the pharmaceutical product under evaluation. At the time of regulatory submission, long-term storage testing for a product should cover a 12-month testing period at minimum. During regular manufacture, retesting for 12-month long-term testing periods should be every three months during the first manufacture year, every six months during the second year and annually beginning with the third year of manufacture.

Accelerated and intermediate storage testing conditions are performed at higher temperatures than long-term storage conditions and may be used to evaluate the effect of short-term excursions outside label-recommended storage conditions (e.g., shipping, etc.). For accelerated storage testing, a six-month study period is recommended with three minimum sampling points: initial test start, three months and six months. Intermediate storage testing is recommended when accelerated studies are likely to yield results suggesting significant product integrity change. Here, inclusion of a fourth sampling time point is recommended. Using a 12-month study as an example, sampling for intermediate storage testing would be recommended at the initial test start, six months in, nine months in and at the 12-month mark.

Our Facilities

CPT offers several state-of-the-art Analytical, Microbiological, Clinical, Photobiology and In Vitro Toxicology departments for our clients’ product testing needs. Our facilities are maintained at a high level of regulatory compliance to ensure the best quality assessments of product safety, stability and efficacy. We strongly adhere to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) standards to ensure the best quality results for our clients. Custom-tailored testing programs and flexible turn-around times are available. Contact us to learn more.