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ICH STABILITY TESTING

Gathering stability testing data on drug products or drug substances to determine an overall stability profile is a necessary step in the drug approval process. Guidelines for stability testing data as listed in ICH Q1A(R2) have been adopted by the European Union, U.S. FDA, and the Japanese Ministry of Health, Labor, and Welfare.

Drug substance, drug product, medical devices, and raw materials need to be assessed for stability. Pacific BioLabs provides stability sample storage and analysis with 24 hour monitoring of controlled chambers and SOP and protocol driven processes.

Stability Storage Conditions

ICH guidelines give storage conditions and times for long-term, intermediate, and accelerated stability studies. Below are the general storage conditions.

  • Long-term studies: 25°C and 60% Relative Humidity (RH) for 12 months, or 30°C and 65% RH for 12 months.
  • Intermediate studies: 30°C and 65% RH for 6 months.
  • Accelerated studies: 40°C and 75% RH for 6 months.

In addition to the ICH compliant standard stability conditions, PBL can provide custom storage conditions (-80°C, -20°C). Other conditions may also be appropriate. For instance, drug product intended for refrigerated storage would undergo long-term storage at 5°C for 12 months.

Stability Study Analysis

PBL can assess the stability profile of products using numerous analytical techniques: HPLC, LC/MS, and GC, for example. Samples are taken at specified time-points and analytically tested to ensure continued viability. For a 24 month accelerated study, samples are typically tested at 1 month, 3 months, 6, 9, 12, 18 and 24 months. In addition, the PBL Microbiology Department can measure sterility, package integrity, endotoxin levels, and bioburden on products.

ICH stability data is required as part of an IND or CTA (EU) submission. Since long-term studies take 24 months or longer, it is prudent for companies to begin gathering stability data once a suitable drug candidate has been selected.

More detailed information can be found in the ICH guideline Q1A(R2) (PDF).

Stability Study Services Offered

  • Storage:
    • 25°C / 60% Relative Humidity
    • 30°C / 65% RH
    • 40°C / 75% RH
    • Other non-standard temperatures and relative humidities
  • Stability Testing and Analysis (HPLC, LC/MS, GC)
  • Forced Degradation Studies
    • Photo Stability
    • Oxidation
    • Thermo Stability
  • Sterility / Microbiological Assessment
    • Sterility
    • Package Integrity
    • Endotoxin Levels (LAL)
    • Bioburden
 
 
 
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