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Originally Published PMPN January 2004

Regulatory Focus

Storage Conditions Revised for Stability Tests

ICH releases updated requirements for such testing in climatic zones I and II.

The International Conference for Harmonization (ICH) has made a second revision to one of its guidances on stability testing. Q1A (R2) Stability Testing of New Drug Substances and Products was first published in September 1994 and revised in August 2001. 
In November 2003, ICH revised it again to harmonize the intermediate storage condition for zones I and II with the long-term condition for zones III and IV recommended in the ICH guidance, Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV. Three revisions have been made to the guidance. 

The first revision involves changing the intermediate storage condition from 30° ±2°C/60% ±5% RH to 30° ±2°C/65% ±5% RH in four sections. These include:

• II.A.7.a (2.1.7.1), Drug Substance—Storage Conditions—General Case
• II.B.7.a (2.2.7.1), Drug Product—Storage Conditions—General Case
• II.B.7.c (2.2.7.3), Drug Products Packaged in Semipermeable Containers
• Glossary (3), Intermediate Testing

The second revision adds 30° ±2°C/65% ±5% RH as a suitable alternative long-term storage condition to 25° ±2°C/60% ±5% RH in the following sections:

• II.A.7.a (2.1.7.1), Drug Substance—Storage Conditions—General Case
• II.B.7.a (2.2.7.1), Drug Product—Storage Conditions—General Case

The final revision adds 30° ±2°C/35% ±5% RH as a suitable alternative long-term storage condition to 25° ±2°C/40% ±5% RH and the corresponding example for the ratio of water-loss rates to the following section:

• II.B.7.c (2.2.7.3), Drug Products Packaged in Semipermeable Containers

The revised guidance states that switching the intermediate storage condition from 30° ±2°C/60% ±5% RH to 30° ±2°C/65% ±5% RH “can be appropriate, provided that the respective storage conditions and the date of the switch are clearly documented and stated in the registration application.”

In addition, ICH recommends that such applications use data from complete studies at the intermediate storage condition of 30° ±2°C/65% ±5% RH by November 2006.

For more information, please visit www.fda.gov/ohrms/dockets/98fr/2002d-0231-gdl0002.pdf.    

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