In this way, the stability studies can be performed for different climatic zones from zone ii to zone ivb, as well as the possibility of carrying out stability studies of cold storage products, as we also offer the possibility of storage under controlled conditions of 5 3. The climate is different in all the countries in the world. Samples of a development batch representative for commercial production were tested after corresponding prestorage for 12, 22, and 35 months over an inuse period of 10 weeks, at climatic zone ii and ivb conditions. Brazil revises stability study standards to bring companies. Q 1 a r2 stability testing of new drug substances and products. Stability studies should be performed on individual strengths of the product andor type of container closure system in which the finished product is packed unless bracketingmatrixing is applied as in appendix 1. Stability studies the purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and. Test methods for stability studies if an assay is to be used for stability testing, its validation needs to evaluate its stability indicating nature, particularly with regards to specificity. This sop is applicable for carrying out stability studies of drug products of pharmaceutical formulation plant. Q 1 a r2 stability testing of new drug substances and.
Patiala, panjab, india recei pharmaceutical product. 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, andor efficacy. Aseanassociation of southeast asian nations guideline for stability of drug products. Conducting stability studies recent changes to climatic. Subsequently, ich withdrew q1f, which covers studies supporting.
Q1ar2 stability testing of new drug substances and products. Long term stability studies should cover all climatic zones if possible, i. Accelerated predictive stability aps is a stability tool that allows users to quickly and perhaps more accurately predict the expiry for both drug substance and drug product waterman et al. Regulatory strategy for longterm stability conditions to. International conference on harmonization ich of technical requirements or registration of pharmaceutical for humane use. In which case, stability studies should follow ich stability guidances closely. Who guideline for stability of pharmaceutical products. To lay down a procedure for carrying out stability studies of drug products. 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. According to the ich guidelines for stability studies, the climate of the world is divided into five different zones. If zone ivb stability data are not available by the time of submission, applicants should initiate as soon as possible longterm stability testing at zone ivb storage conditions in the same packaging as approved by the reference sra for marketing of the product. Regulatory expectations and industry practice on stability. Dec 12, 2018 the expiration dating must be confirmed with actual 24 months long term studies.
The stability conditions have also been harmonized and. Three stability studies simulating patient use were performed on aclidinium bromide 400. Subtropical with possible high humidity averaging 20. In 2006, fda has withdrawn their stability guidance and reference ich q1ar2 for stability testing. If the product is intended to be marketed in several climatic zones, it is up to the applicant. Ich stability studies zones ii to ivb netpharmalab en. The asean common technical dossier actd for the registration of pharmaceuticals for human use organization of the dossier preamble this asean common technical dossier actd is a guideline of the agreed upon common format for the preparation of a wellstructured common technical dossier ctd applications that will be submitted to asean. Brazils medicines regulator anvisa intends to update its criteria for stability studies for medicines so as to bring them into line with ich guidelines and give drug developers more certainty. Outsourcing stability studies to contract laboratories. Longterm stability studies conducted at zone iva and. Request to submit stability data with the submission of.
Although brazil is now an ich official member, anvisa requires who zone ivb for stability storage conditions, including active pharmaceutical ingredient api that has different storage requirements based on the country of manufacture and exported to brazil. Based on years of experience our expert, kerry bradford, shares her thoughts on what steps you can take to ensure that your outsourced stability studies run like clockwork. Climatic zone definition storage condition i ii iii iv temperate climate subtropical and mediterranean climates hot, dry climate hot, humid climate 21c45% r. Data from the accelerated stability studies can be used to evaluate the effect of short term excursions outside the label storage conditions such as during shipping. Samples of a development batch representative for commercial production were tested after corresponding prestorage for 12, 22, and 35 months over an inuse period of 10 weeks, at climatic zone ii and ivb. The temperature and long term testing conditions for the four zones are mentioned below. Annex 2 stability testing of active pharmaceutical. Stability studies regulatory affairs in latin america. Sop on stability studies for drug products pharma pathway.
Ich stability zones published by pharmastate blog this is a platform for people working in the pharmaceuticals industry for discussions, jobs, news updates, professional profile display space and company business pages. Global stability program a long journey to harmonization. Storage conditions and time points for stability studies during clinical development. The accelerated stability testing data at 40c 75% for minimum six months and long term stability testing data at 30c 65% for minimum 12 months should be available at the time of submission for new drug application and can be continued further. For the purpose of stability testing ich recommended the world climate into four zones, namely, i,ii,iii ad iv.
We continue to believe that the actual conditions in the majority of countries in zone iv are adequately addressed by stability studies conducted at 30c 65% rh as a. Stability studies in a global environment geneva, 14. Powered by create your own unique website with customizable templates. Mar 10, 2015 testing conditions long termrealtime stability testing climatic zone temperature humidity minimum duration zone i 21. Brazil, the largest country in south america, has become the second largest pharmaceutical market in the emerging world. Requirements for stability studies of finished pharmaceutical. Mar 01, 2011 zone i was defined to temperate, zone ii subtropical or mediterranean, zone iii hot and dry, and zone iv hot and humid. Guidelines on stability testing of cosmetics colipactfa.
Formal studies primary stability studies are intended to show that the drug substance will remain within specification during the retest period if stored under recommended storage conditions. The stability studies is one of the very important parameters of pharmaceutical products. While aps may be most valuable for product development, packaging selection, evaluation of process deviations and other nonregulatory applications, aps data can be incorporated. These studies are required to be conducted in a plan swami vivekanand college of 3354. Stability data must demonstrate stability of the medicinal product throughout its intended shelf. Specification testing parameters a stability study should cover the testing of the physical, chemical, and microbiological. Stability data evidence is required to demonstrate that product is stable, meets the finished product specifications throughout its proposed shelflife, that toxic decomposition products are not produced in significant amount during this period, and that potency, efficacy of preservative etc. The basic concepts of stability data evaluation are the same for single versus multifactor studies and for full versus reduceddesign studies.
Stability assessment and shelflife prediction is usually a major focus of a pharmaceutical scientists. Accelerate, intermediate and long term stability studies evaluation of the stability data summarizing the stability data trends, significant changes, out of specification results oos. Vich gl58 stability testing in zones iii and iv step 4. Global climatic zone divisions for stability studies on. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes. Presentation onstabilitystudy of pharmaceutical product. Q1c stability testing for new dosage forms q1d bracketing and matrixing designs for stability testing of new drug substances and products q1e evaluation of stability data q1f stability data package for registration applications in climatic zones iii and iv withdrawn q5c stability testing of biotechnological.
In table 2 of the who guideline the longterm stability conditions for who member states by region are listed, with south africa indicated as zone iva. Classification of countries according to climatic zones. This work provided a basis for the ich to propose a unified approach among the united states, the european union, and japan, all in climatic zone ii, for stability studies to be performed at 25. Icdra session on stability, singapore zone ivb climatic conditions common deficiency. Stability testing of new veterinary drug substances and. No intermediate storage condition for stability studies is recommended for climatic zones.
Selection of batches stability information from accelerated and long term testing is. Objectives of the guideline the following guideline is a revised version of the ich q1a guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a. The data from accelerated study and ongoing real time stability study can be used to justify an interim extrapolated shelflife. Introduction general the purpose of stability testing cosmetic products is to ensure that a new or modified. Objectives this guideline is intended to provide recommendations on the core stability study package required for drug products, but leaves sufficient flexibility to encompass the variety of different. The zone iv was subsequently split into zone iva and ivb. The product stable for 6 months at 40c 75% accelerated stability testing conditions.
Conducting stability studies recent changes to climatic zone iv. The guideline on stability testing for climatic zone iii and iv takes up a proposal made by who and now defines not only storage conditions for stability testing relevant for the ich tripartite regions europe, usa, japan, but also completes the recommendations for the standardization of the storage conditions for the climatic zones iii dry. Stability testing of pharmaceutical products article pdf available in journal of applied pharmaceutical science 23. Stability program overview for pharmaceutical products. Data from formal stability studies and, as appropriate, supporting data should be evaluated to determine the critical quality attributes likely to influence the quality and performance of the drug. Failure to conduct studies at zone ivb hot and very humid climatic conditions of 30 2oc and 75 5%rh. Selection of batches stability information from accelerated and long term testing is to be provided on at least three batches. Ivb hot and very humid climate 22 c 27 hpa 30 c 75 % rh south africa is classified in cz ii. This guidance is the second revision of q1a stability testing of new drug substances and products, which was first published in september 1994 and. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. Ich stability requirements overcoming the challenges. The four zones into which the world is classified based on the prevailing annual climatic conditions, i.