Climatic Zones for Stability Studies (2024)

FAQs

Who climatic zone for stability studies? ›

Know different climatic zones by ICH in the world for stability conditions including Temperate, Mediterranean / subtropical, Hot dry, Hot humid / tropical and hot & higher humidity zones.

The stability information should include, as appropriate, results from the physical, chemical, biological, and microbiological tests, including those related to particular attributes of the dosage form (for example, dissolution rate for solid oral dosage forms).

The WHO Expert Committee on Specifications for Pharmaceutical Preparations decided to split Climatic Zone IV into Zone IVa (hot and humid) with storage conditions of 30°C/65% RH and Zone IVb (hot and very humid) with storage conditions of 30°C/75% RH.

Climate zones are determined by the temperature, precipitation, and long-term weather patterns in an area. These factors are largely controlled by the latitude of the area, wind patterns, and geological features nearby. For example, many hot, dry deserts exist at 30 degrees latitude above or below the equator.

The Köppen climate classification divides climates into five main climate groups, with each group being divided based on patterns of seasonal precipitation and temperature. The five main groups are A (tropical), B (arid), C (temperate), D (continental), and E (polar). Each group and subgroup is represented by a letter.

Summers are hot and dry with a large daily temperature swing. Summers are hot enough that cooling is necessary. Winters are cool but not severe. Heating is necessary on many days in the winter. Days are typically clear with the coastal range blocking much of the fog and high winds.

Long-term stability testing is also referred to as room temperature stability storage condition testing. The most common storage condition is 25°C +/- 2 degrees and RH of 60% +/- 5%. This and other storage conditions are outlined in the ICH Guidelines for Stability Testing.

The type of stability is generally divided into chemical, physical, microbiological, therapeutic, and toxicological.

Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes.

What is the FDA guideline for stability testing? ›

The FDA stability guidance recommends 6 months of accelerated data and 6 months of long-term data for the pilot scale batches to be submitted for a full scientific review of the DMF.

In general, “significant change” for a drug product is defined as: 1. A 5% change in assay from its initial value; or failure to meet the acceptance criteria for potency when using biological or immunological procedures; 2.

This is a zone that offers a good balance of long, warm summers and chilly winters, making it an excellent climate zone for commercial fruit growing. That's why you'll find orchards in this zone in almost every state in the West.

The ICH has established five different climatic zones for stability studies.

Standard conditions (climatic zone II): 25ºC/60%RH; 30ºC/65%RH; 40ºC/75%RH. Tropical conditions (climatic zone IVb): 30ºC / 75%RH.

Highly stable formulations may be tested after the first 12 months and then at the end of the shelf-life. Products containing less stable drug substances and those for which stability data are available should be tested every 3 months in the first year, every 6 months in the second year, and then annually.

TRS 1010 - Annex 11: Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities.

Geneva, World Health Organization, 1992. Storage in dry, well-ventilated premises at temperatures of 15–25 °C or, depending on climatic conditions, up to 30 °C. Extraneous odours, other indications of contamination, and intense light must be excluded.