Stability zone iva countries Humidity influences physical stability, particularly in hygroscopic products like tablets and capsules. be followed to generate stability data package for a registration application in countries or regions in Climatic Zones I, II and IVA. In the drug file, the requirements fall ICH stability zones Zone Type of climate Mean kinetic temperature (Deg C) Yearly average relative humidity (% Rh) Example countries Zone-I Temperate 21 45 USA, Canada Zone-II Subtropical with high humidity 25 60 Southern Europe, Japan Zone-III Hot and dry 30 35 Iraq, Jordan Zone-IVa Hot and humidity 30 65 Egypt, Uganda Zone-IVb Hot and high Protocol of Stability Study (example) 20 5. Report Format (example) 24 5. Globally many countries fall into IVA. A recent breakthrough has Thank-you for your response. Climate/definition Major countries/region MAT 30°C/75% RH 3, 6, 9, 12, 18, 24, 36 Long term for Zone IVa, or It is one of the key compliance elements for drug file approval in the SFDA and the GCC countries. Following the WHO process for consultation a general text on stability and the WHO Guidelines on stability testing for well established drug substances in conventional dosage forms were adopted in 1994 and 1996, respectively. The climate is different in all the countries in the world. Zone II – subtropical. Tip: Identify the target market’s climatic zone early to align stability testing protocols with local regulatory requirements. The reference SRAs are currently all from zone II areas (Europe, USA, Canada). Key Storage Conditions for Stability Testing. Kshitiz Kumar Gaund As CEO of Prima Saigon, the country's leading international daycare and ambulatory hospital, Bao has turned the institution into a benchmark of excellence, setting climatic zone IV has now been split into IVa and IVb. On the 37 th Report of The WHO Expert Committee on Specifications for Pharmaceutical As different countries have different climatic conditions, each health authority requires stability studies to be conducted in the conditions corresponding to their ‘climatic zone’. According to temperature and humidity impact can be observed Until September 2011 the WHO Prequalification Team: medicines (PQTm) encouraged the submission of long-term stability data at Zone IV conditions (30oC/65% for IVa or 30oC/75% Read more about ICH stability zones i. Stability studies of pharmaceutical products under ICH guidelines. countries not located in the ICH regions and not covered However, based on new calculations and discussions, some countries in Climatic Zone IV have expressed their wish to include a larger safety margin for This condition helps to test the stability of products in moderately warm and humid conditions, typical of many regions. h The Committee further resolved that each individual Member State within the former Zone IV will need to classify itself as Zone IVa or IVb. Information obtained through respective regional harmonization groups (e. 3. Climatic Zone: Temperature: Humidity: Minimum Zone IV: Hot and Humid Climate. This process is still ongoing and leads into a situation where some of the benefits of the former STABILITY DATA (ACCELERATED STABILITY, LONG TERM STABILITY, ZONE 4b) Introduction. The document discusses climatic zones for stability studies established by the International Conference on Harmonisation (ICH). The present zone IV becomes zone IVa and a new climatic zone IVb is added to accommodate hot and very humid areas zone IVb countries - India, china, cuba, brazil and all asian countries Nevertheless, some countries in Climatic Zone IV revised their stability guidelines and communicated the need to include a bigger margin of the percentage in RH, defining their long-term storage conditions as 30 °C/75% RH. de Internet: www. 30°C/65%RH (zone IVa) and 30°C/75%RH (zone IVb). 8. The temperature and long term testing conditions for the four zones are mentioned below. So even though 40°C / 75 % RH is the harshest stability condition for accelerated studies this alone is not sufficient to cover Climatic Zones III and IVa IVb - you would also expect to see long term studies at either 30°C / 35 % RH for Zone III and 30°C / 65 % RH for Zone IVa and 30°C / 75 % RH for Zone IVb? Stability zones are split into four distinct categories: Zone I – temperate. in Climatic Zone III (hot and dry) and IV (hot and humid). , prolonged release forms) or when the drug substances are known to be unstable, stability The storage conditions for long-term stability studies mentioned are 25 °C ± 2 °C/60% RH ± 5% RH and 30 °C ± 2 °C/65% RH ± 5% RH. Stability Requirement In ASEAN region, the stability temperature and relative humidity requirement are 30±2°C/65±5% Zone IV into two sub-zones: Hot & Humid (IVa) and Hot & Very Humid (IVb) to accommodate several regions that experience very high temperature and humidity. I and II. The guidelines are expected to be made available shortly. Long term Stability testing which could be realized in order to cover all climatic zones. This option is not allowed for products of Zone IVA where no extrapolation is allowed if data of accelerated conditions do not meet the room temperature specifications. poli-tape. Pharmacy (T4. It is not economically practical to perform two sets of Zone IV stability studies, one at 30ºC/65%RH and another at 30ºC/75%RH. 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. • Zone IVb: 30°C / 75% r. de 11/2016 Zone 1 (moderate climatic zone) Zone 3 (subtropical climatic zone) All sites over 1000 m above South Africa is classified in CZ II. The mean daily temperatures and dewpoints measured four times per day at selected places in Southeast Asia, South America, China, Southern Africa and the Caribbean are used The parent guideline describes the stability data package for the ICH tripartite regions (EC, Japan, and the United States), which are in Climatic Zones I and II. Stability studies of the drug product and drug substances should be done according to the climatic conditions of the country. Stability conditions for WHO Member States by Region. These conditions are very similar to climatic zone II and IVa of WHO stability testing guidelines . In some of the countries Intermediate stability condition is considered as long term testing condition. Menurut pedoman ICH untuk studi stabilitas, iklim dunia dibagi menjadi lima 15 ICH Q1F ICH Q1F was withdrawn: –WHO survey: consensus – adopted and implemented in 2003 in non ICH countries 30 0 C/65% RH: long term storage conditions for climatic zone III/IV countries –Some countries in climatic zone IV: 30 0 C/75% RH; long term storage conditions for hot and humid conditions –ICH Q1F was withdrawn due to the divergence in global stability conditions for Zone IV as follows: • Zone IVa: 30°C / 65% r. Stability testing is a to classify itself as Zone IVa or Zone IVb. COURSE CATEGORY. It is further divided into: Zone IVa: 30°C and 65% RH. 6. humid conditions in the ASEAN countries. CLIMATIC ZONES: COUNTRIES AND DURABILITY POLI-TAPE GROUP Zeppelinstraße 17 53424 Remagen - GERMANY Phone: +49. ICH stability zones: Example: Antibiotics like penicillin degrade more rapidly at elevated temperatures, reducing potency. ). consultation, conditions for real-time stability studies for climatic zone IV were agreed as 30 ˚C (± 2 ˚C) and 65% (± 5%) RH (2). This guideline has been Revised [16,23] According to ASEAN guidance, climatic zone IV was subdivided into zones IVa and IVb to suit conditions in a nation where there was extreme humidity condition of 75% RH throughout the year The external stability risk factors heat and moisture are evaluated with respect to the development of pharmaceutical products intended to be marketed in tropical and subtropical countries. What is the Importance of Stability Zones in the Regulatory Context? The classification of stability zones is important for several reasons within the regulatory defined storage conditions for stability testing in countries located in Climatic Zones III (hot and dry) and IV (hot and humid), i. To reduce the amount of stability testing, the number of different long term testing conditions may be streamlined as Conditions for stability testing in ASEAN countries Type Conditions and zone IVa being hot and humid areas The official revised guideline could be available by the end of May 2006 • This guideline defined the storage conditions for stability testing in countries located . The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use is a global body that brings together regulatory authorities and the pharmaceutical industry. 30°C / 65% RH storage conditions are suitable for intermediate and long-term trial conditions for climatic zones I, II, III and IVa. Zone IV: Hot and humid climates, subdivided into: Zone IVa: 30°C ± 2°C / 65% RH ± 5% RH. 100 m² EMA and FDA inspected storage capacity. 983 637 E-Mail: info@poli-tape. four climatic zones distinguished for the purpose of easy comprehension for a worldwide audience. Argentina, Bolivia, Chile, Canada, Keywords: Stability, climatic zones, ICH Q1F, withdrawal, ICH Q1A (R2) Current effective version ICH: Q 1 F: Stability data package for registration in climatic zones III and IV. CLIMATIC ZONES Schumacher/Grimm In order to be able to reduce the amount of stability testing, the number of different testing conditions must be reduced to a sufficient extent. 21 o C/ 45% RH. Home; About us. e. For example: Zone I: 21°C/45% RH for temperate regions. Studi stabilitas obat di industri farmasi harus dilakukan sesuai dengan kondisi iklim negara tersebut. Stability studies are a key pillar in the development and approval of pharmaceutical products and must comply with established international guidelines, in conditions for Zone IV as follows: • Zone IVa: 30°C / 65% r. All countries--America. As per ICH Q1A R2 you can substitute 30C/65RH for 25C/60RH which is Zone II for Europe and North America. Skip to content. MEMBER STATE STABILITY CONDITIONS CONFIRMED LONG-TERM TESTING ONDITION Regional Office for Africa (AFRO) Algeria [25 °C/60% RH]3 Angola [30 °C/65% RH]3 Benin [30 °C/65% RH]3 PharmaSciences Climatic Zones for Stability Study - ,Definitions of significant changes of data stored at accelerated conditions, Mean Kinetic Temperature Hot dry zone ˃ 22°C /≤15 hPa: 30 / 35: Zone IVa: Hot humid/tropical zone ˃ 22°C / ˃ 15 to 27 hPa: 30 C / 65% RH: Zone IVb: Zone I and II countries: Zone III and IV countries The ASEAN countries and Brazil, among other regions/countries, are now adopting a position of 30 °C/75% RH as the most appropriate long-term storage condition. As a result of the discussions in the consultation, it was recommended that the existing WHO guideline on stability testing should be reviewed in the light of new information on climatic conditions in Zone IV as raised by Asian countries. No intermediate storage condition for stability studies is recommended for Climatic ZonesIIIandIV. Grimm, W. In 2006, FDA has withdrawn their stability guidance and reference ICH Q1A(R2) for stability testing. As per ICH guidelines for stability studies, the climate of the world is divided into four different zones (Zone I, II, III, IV. The International Conference on Harmonization (ICH) Tripartite Guideline "Stability Testing of New Drug Substances and . ASEAN, ICH and GCC) and from official communications from national medicines regulatory authorities to WHO zone iva: hot/higher humidity zone Zone IVb, or the Hot/Higher Humidity Zone, represents areas with extreme humidity and high temperatures. This has been proposed by Paul Schumacher in 19728 and Wolfgang Grimm in 19869 and in Stability Zone ASEAN countries come under stability zone IVa and IVb while GCC countries come only under zone IVa. All climatic zones. Subsequently, ICH withdrew Q1F, which covers studies supporting Energy-efficient stability chambers minimize environmental impact while maintaining accurate testing conditions. Countries: Climatic Zones: USA: I, II, III, IVa: Russia: I: China: I, II, IVa: India: III The zone IV was subsequently split into zone IVa and IVb. Case Study: Intermediate Stability Testing for a Combination Drug. Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. Choose environmental conditions based on the target zones. In Accelerated Zone III 40°C ±2°C/NMT 25% RH 6 months Accelerated Zones IVA & IVB 40°C ±2°C/75 ±5% RH 6 months * Same conditions as for the alternative long term storage conditions for Zones I and II as describedinthe parent guideline. This helps identify the relevant stability zones for testing. This article will detail the minimum requirements for SFDA drug registration. I. Before designing your stability program, determine the target markets for your pharmaceutical product and their corresponding climatic zones: Zone II: Europe, Japan, the United Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities Safety Guidelines. An appropriate long-term stability testing condition is proposed for each selected country, related to the worst case for each specific region and the safety margins, as well as its classification in either Climatic Zone IVA or IVB. • For critical dosage forms (e. conditions for long-term stability studies are proposed to facilitate the categorisation of different hot and humid countries in Climatic Zone IVA and IVB. This guideline provides additional guidance on the storage conditions for stability testing to be used for products intended to be marketed in countries located in Climatic Zones III (hot Stability zones and ich guideline q5c. The degradation of the product will be faster in higher category zones The external stability risk factors heat and moisture are evaluated with respect to the development of pharmaceutical products intended to be marketed in tropical and subtropical countries. The parent guideline can be followed to generate stability data packages for registration gorisation of different hot and humid countries in Climatic Zone IVA and IVB. 5 The general conditions for long term stability testing in the ASEAN region are the Zone IVb conditions (30oC/75% RH). The document outlines 5 zones for long-term stability testing of pharmaceutical products based on climate conditions, with Zone I representing temperate climates and Zone IVb representing hot humid tropical climates like Southeast Asia. The International Council for Harmonisation (ICH) stability zones provide a standardized framework for stability testing, ensuring that pharmaceutical products remain safe and effective The World Health Organization (WHO) put out the idea of dividing Climatic Zone IV into two distinct zones, IVA and IVB, in the year 2005. CAPP. [2] Zone I In October of 2005, the WHO took the position of creating a Zone IVa and IVb which would have long-term stability data requirements of 30ºC/65% RH and 30ºC/75% RH, respectively, and allowing each country to designate ICH- Different Climatic Zones for Stability Studies. Zone I and II countries. 3 Definitions Climatic Zones. Since ICH stability testing is designed to determine how a drug reacts under different environmental conditions, the climatic zones have been created to allow DRUG STABILITY TESTING Classification of Countries According to Climatic Zonesc Country Climatic Zones Assigned To Syria II II Tadzhikistan I, II II Taiwan IV IV Tanzania II, IV IV Thailand IV IV Togo IV IV Tonga II, IV IV Tunisia II II Turkey I, II II Turkmenia I, II II Uganda IV IV United Arab Emirates IV IV ± 5% RH). In Table 2 of the WHO guideline the long-term stability conditions for WHO Member States by Region are listed, with South Africa indicated as zone IVA. h. SRA storage statements and WHO recommended storage statements . 2. 1. By aligning stability testing protocols with these zones, pharmaceutical stability testing conditions for climatic zone IV, ie hot and humid countries. This condition of 30°C ± Read more about ICH stability zones i. Zone IVb: 30±2°C/75±5% RH. Reduced Design (Bracketing and Matrixing) 30 5. Kymos Climatic Zones IVa and IVb[7]. OBJECTIVES This guideline is intended to provide recommendations on the core stability This conditions are 30⁰C/75%RH, especially for countries defined as IVB zone – the region which is more humid than zone IVA (30⁰C/65%RH). Zone IVa: 30°C ± 2°C and 65% RH ± 5% Zone IVb: 30°C ± 2°C and 75% RH ± 5% (Very humid) ICH stability zones provide a critical framework for designing stability studies that reflect real-world conditions in diverse climates. The guidelines are expected to Since some Zone IV countries require 30ºC/75%RH stability studies while others will accept 30ºC/65%RH data, firms wishing to register their drugs globally are faced with a dilemma. (0)2642. Select Testing Conditions. CRO for GMP-certified ICH stability studies and ongoing stability studies. It’s a subset of the tropical zone, with even more challenging environmental The world is divided into four climatic zones & zone IV is further subdivided into two zones which are IVa & IVb so by adding by division we have 5 ICH climatic zones. Due to this divergence in global stability testing requirements, the ICH Climatic Zone IV A is 30C/65RH, IV B is 30C/75RH. COURSES. Adopted Reference Number: CPMP/ICH/421/02 Legal In addition, they recommended that each zone would have different storage conditions; i. Step 2: Identify Target Markets and Climatic Zones. Guidelines 2. Europe. 1 Update March 2021 . 983 60 Fax: +49. Four climatic zones, I-IV ICH Stability Zones/ Zone IVA, the intermediate storage condition in the General Case for Zones I and II in the parent guidance has been revised to 30°C ± 2°C/65% RH ± 5% RH. A pharmaceutical company developing a combination oral tablet for Zone IVa markets faced challenges in ensuring stability under moderately humid conditions. 1 Active substances 2. Zone IVb: 30°C ± 2°C / 75% RH ± 5% RH (very hot and humid). In 2000, discussions were initiated between the i STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS ICH Harmonised Tripartite Guideline First Recommended for Adoption at Step 4 of the ICH Process on 27 October 1993. Students shared 114 documents in this course ICH Stability Zones Zone Type of Climate Zone I Temperate zone Zone II zone Zone Hot dry zone Zone IVa Hot zone Zone IVb humidity These stability studies zones are created due to the Zone IVa: Hot and humid climates (30°C ± 2°C, 65% RH ± 5%). ASEAN countries like Philippines, Thailand, Vietnam are IVB. The stability of finished pharmaceutical products depends on several factors The document discusses climatic zones for stability studies as defined by the International Conference on Harmonisation (ICH). Testing under more restrictive condition, (30⁰C/75%RH), might have huge impact on product development and production processes: (30 C/75%RH). “Extension of the International Conference on Harmonization Tripartite Guideline for Stability Testing of New Drug Substances and Products to Countries of Climatic Zones III and IV” the storage requirements for stability testing in climatic zone III (hot . Following lengthy discussions, the World Health Organization (WHO) has revised its guidelines on stability testing conditions for climatic zone IV, ie hot and humid countries. Course. The minimum time duration for long-term studies is 12 months. There are also ICH guidelines for stability testing, that are to be Zone IV (Hot and Humid Zone):This zone includes areas with high temperatures and high humidity. It divides the world into 5 climatic zones based on temperature and humidity: Zone I (temperate), Zone Stability testing of active pharmaceutical ingredients and finished pharmaceutical products . The numbering of climatic zones for stability studies is As a consequence, several countries and regions have revised their own stability testing guidelines, defining up to 30 °C/75% RH as the long-term storage conditions for hot and humid ICH stability zones and their types: Zone 4 has devided into 2 zones as per climatic condition. This document discusses recent changes to stability testing guidelines for Climatic Zone IV regions, which include hot, humid countries. g. ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. 1、本站为技术交流论坛，发帖的内容具有互动属性。您在本站发布的内容： ①在无人回复的情况下，可以通过自助删帖功能随时删除（自助删帖功能关闭期间，可以联系管理员微信：8542508 处理。 Thus, the stability studies may be restricted to the dosage forms. Zone IVb: 30°C and 75% RH. 25 o C/ 60% RH. The stability of finished pharmaceutical products is influenced by a variety of environmental elements such as temperature, humidity and light and product-related factors like chemical and physical properties of the active ingredient and pharmaceutical excipients, the The adjustments that are necessary to extend the stability testing requirements for a registration application within the three areas of the European Union, Japan, and the United States to countries of climatic zones III and IV are described. Zone IVb – high humidity and hot. supplied to zone III, IVa and IVb countries with the WHO recommended storage statement. “Drug Stability Testing – Classification of countries according to climatic zone” Drugs made in Germany, 36: 99-103, 1993 4. The all Countries Stability Zone information and Country time zone. Hence 30C/65RH can satisfy the majority of regions. 1) 114 Documents. Stability climatic zones of the world are decided based on their temperatures. Depending upon the climatic zones, different long term testing conditions are defined by the WHO and ICH as shown in Table 2 below. High humidity levels in Zones IV and IVA can lead to caking, dissolution, or microbial contamination. A Iklim di semua negara di dunia berbeda. Each climatic zone has recommended storage History of discussions Conclusion At the 40th WHO Expert Committee Meeting, October 2005, the Committee determined that the WHO stability guidelines should be amended to reflect conditions for Zone III and IV as follows: Zone Stability testing of active pharmaceutical ingredients and finished pharmaceutical products . Marketing; Zone IVa: Hot humid/tropical zone: Zone IVb: ASEAN testing conditions hot/higher humidity: LONG TERM TESTING CONDITIONS. Why outsourcing might be the best choice for solutions) and when the drug substances are known to be stable, stability data on at least two pilot scale batches are acceptable. Zone III – hot and dry. 4. The present Zone IV (30 C/65%RH) would become Zone IVa. Revised under Step 2 of the ICH Process on 7 October 1999 and Recommended for Adoption at Step 4 of the ICH Process on 8 November 2000. Hence, the stability study of the pharmaceutical product needs to be studied keeping in mind the climatic conditions of the country. Where special Table 1 – Proposed conditions for stability testing in ASEAN countries TYPE CONDITIONS Products in primary containers 30 oC ± 2 C/75% ± 5% RH any part of the region were calculated, and accordingly climatic zones were assigned for each country of the Region (see Annex 1). World stability climatic zones. Humidity. The ICH has established five different climatic zones for stability studies. 1 General Information on the stability of the active substance is an integral part of the systematic approach to stability evaluation. 1. 5–7 These are now classified as Zone IVB countries. 018 humidity and duration for climatic zone IVa for the submission of stability study dossier for the from reference and non -reference countries submitted to General Administration of Stability. Zone IVa – tropical. Long-term stability studies conducted at zone IVA and IVB conditions, instead of or in addition to zone II will also be acceptable. This article summarises the key events that have marked the WHO’s work on developing international stability testing guidelines. 2. Specifically: 1) Stability testing guidelines were amended to reflect storage conditions of Hence, it is proposed that Zone IVA should cover hot and low humid climates with storage condition of 30°C/65% RH, a new zone IVB condition should be added to cover hot and moderately humid climates of 30°C/70% RH, while the originally proposed Zone IVB storage condition should be restricted to hot and very humid climates and converted as The work on stability was initiated by the World Health Organization (WHO) in 1988. Subsequently, ICH withdrew Q1F, which covers studies supporting As per ICH guideline world is devided into four climatic zones. This process is still ongoing and leads into a situation where some of the benefits of the former To avoid having to carry out special storage tests for each country, four climatic zones CZ Definition Criteria Mean annual temperature measure in the open air/Mean annual water vapour pressure • The assignment of CZ II, instead of CZ IVA, stability testing conditions for pharmaceuticals to be stored at or below 25 °C in South Africa The primary aim of carrying out stability studies of drug products is to determine the expiration date and to promise the product standardized for efficacy, safety, and elegance throughout its Guidelines On Stability Testing Of Finished Pharmaceutical products and Active Drug Substance Code: EDREX: GL. It also provides the standard long-term, accelerated, and intermediate testing conditions for temperature and humidity in each zone, with a Download scientific diagram | ICH Climatic zones and long-term stability conditions [6,9,14]. Their label storage conditions and stability data requirements are thus related to zone II climatic conditions. Zone III and IV countries. Long term. Zone IV is further divided into two, zone IV A and zone IV B. The stability conditions for these zones are as follows: Zone IVa: 30±2°C/65±5% RH (Relative Humidity). Zone IV into two sub-zones: Hot & Humid (IVa) and Hot & Very Humid (IVb) to accommodate several regions that experience very high temperature and humidity. MEMBER STATE STABILITY CONDITIONS CONFIRMED LONG-TERM TESTING ONDITION Regional Office for Africa (AFRO) Algeria [25 °C/60% RH]3 Angola [30 °C/65% RH]3 Benin [30 °C/65% RH]3 The climate is different in all countries in the world. from publication: Drug Stability: ICH Stability Zone: ASEAN countries fall under stability zones IVa and IVb. 25 0 C/ 60% RH. Regulatory authorities have agreed to accept studies with more restricted humidity conditions [1,12] (Table 2, Figure 3). [1] It outlines five climatic zones based on differences in temperature and humidity around the world. It aims to streamline and standardize drug development and approval processes.
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