Due to this divergence in global stability testing requirements, the ich steering committee has decided to withdraw ich. Merely applying the same requirements applicable to other markets could potentially lead to substandard products, e. These conditions have been derived on the basis of the mean annual temperature and relative. Mar 01, 2011 grimm examined world climatic data and demonstrated the importance of taking this into account by proposing different stability conditions for different climatic zones 1,2. The draft regional guidelines on stability testing of active substances and pharmaceutical products are the product of the consultation. Paula correia, carla vozone, nastaran sigari, carole evans, eva castro, lilian gonzalo, lee nagao brazil is in the zone iv climate condition hothumid. According to the ich guidelines for stability studies, the climate of the world is divided into five different zones. The measured, calculated and derived data for climatic zones iii and iv are summarized in the following tables 5 and 6. The trial should take into account the climatic zones that the product will be marketed in. Stability data package for registration in climatic zones iii and iv step 4 in the ich process comments for its application. 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q1e evaluation of stability data q1f stability data package for registration applications in climatic zones iii and iv withdrawn q5c stability testing of biotechnological. Stability testing of new veterinary drug substances and.
This document is an annex to the ich parent stability guideline and addresses the recommendations on what should be submitted regarding stability of new dosage forms by the. By carrying out stability testing we can find out the shelf life and expiry date can be. In early stages, accelerated stability testing at relatively high temperatures andor humidity is used in order to determine the type of degradation products which may be found. Stability testing is the systematic approach towards drug development process. Stability studies regulatory affairs in latin america. Pdf the stability studies is one of the very important parameters of pharmaceutical products. Note for guidance on ich q1f stability data package for. If an assay is to be used for stability testing, its validation needs to evaluate its stability indicating nature, particularly with regards to. Global stability program a long journey to harmonization. Data package for registration applications in climatic zones iii and iv. Cpmpqwp57696 note for guidance on stability testing for a type 2 variation to a marketing authorization cpmpqwp 15996 note for guidance on maximum shelflife for sterile products after first opening or following reconstitution climatic zones for stability testing for the purpose of stability testing, the whole world has been divided into. Vich gl58 stability testing in zones iii and iv step 4 european. Print version of stability testing for prescription medicines pdf, 740 kb contents. Photostability testing of new drug substances and products q1c stability testing for new dosage forms q1d bracketing and matrixing designs for stability testing of new drug substances and products q1e evaluation of.
Countries assigned to the climatic zones iii and iv 4. Climatic zones for stability testing for the purpose of stability testing, the whole world has been divided into four zones i iv depending upon the environmental conditions the pharmaceutical products are likely to be subjected to during their storage. Conducting stability studies recent changes to climatic zone iv. Subtropical with possible high humidity, averaging 20. 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. Failure to conduct studies at zone ivb hot and very humid climatic conditions of 30 2oc and 75 5%rh.
Stability testing of active pharmaceutical ingredients and. Stability study programs and testing troubleshooting, investigation root cause identification of oos, oot and ooe may occur during stability studies all types of stability climatic zones. It does not create or confer any rights for or on any person and does not operate to bind fda or the public. Stability testing under conditions exceeding those used for accelerated testing. Regulatory guidelines on stability testing and trending of. Stability testing ensures that a drug substance will be safe. Basic concepts and objectives essential definitions according to ich. Stability testing of pharmaceutical products is a complex set of procedures involving considerable cost, time consumption and scientific expertise in order to build in quality, efficacy and safety in a drug formulation. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. The who essential medicines and health products information portal was designed and is maintained by human info ngo. Q 1 a r2 stability testing of new drug substances and products.
Annex 5 guidelines for stability testing of pharmaceutical. Testing at a more severe longterm condition can be an alternative to. Stability testing of apis and fpps who stability guide in trs953. Stability testing of new veterinary drug substances and medicinal products in climatic zones iii and iv vich gl58 guidance for industry. Stability data package for registration in climatic zones iii and iv stress testing. Table 3 conditions for the accelerated stability testing climatic zone storage temperature 0c. As a consequence, several countries and regions have revised their own stability testing guidelines, defining up to 30c75 % as the longterm storage conditions for hot and humid regions. Ich q1ar2 guideline stability testing of new drug substances and products comments for its application. This guidance is the second revision of q1a stability testing of new drug substances and products, which was first published in september 1994 and revised in august 2001. Guidelines on stability testing of cosmetics colipactfa. Stability testing of new drug substances and products step 5 note for guidance on stability testing. This is done not only to ensure compliance with any applicable regulatory standards, but also to determine the reliability of a. Stability of drug substances and their products is required to be ensured throughout their retest periodshelflife.
Storage conditions are derived from real climatic conditions. The design of the stability testing programme should take into account the intended market and the climatic conditions in the area in which the drug products will be used. Stability testing for new dosage forms annex to the ich harmonised tripartite guideline on stability testing for new drugs and products ich harmonised tripartite guideline having reached step 4 of the ich process at the ich steering committee meeting on 6 november 1996, this guideline is recommended for adoption. Stability testing of new drug substances and products european. Stability program overview for pharmaceutical products. Mar 17, 2015 climate zones the design of the stability testing programme should take into account the intended market and the climatic conditions in the area in which the medicinal products will be used. In essence, 30 c75% rh is the most severe condition for longterm study. Stability testing of new drug substances and products hereafter referred to as the parent guideline and outlines the stability data package for a new drug substance or drug product that is considered sufficient for a registration application in territories in climatic zones iii and iv1, 2. Long term stability studies should cover all climatic zones if possible, i. A comparison of brazil anvisa and ich stability requirements for inhalation products. Stability data must demonstrate stability of the medicinal product throughout its intended shelf. The second is a revised guidance entitled q1ar2 stability testing of new drug substances and products the q1a guidance. The gcc guidelines for stability testing of active.
Ich step 5 recommended for adoption 6 february 2003 note for guidance on stability testing. A comparison of brazil anvisa and ich stability requirements. The protocol for stability testing is a prerequisite for starting stability testing and is necessarily a written document that describes the key components of a regulated and wellcontrolled stability study. Regulatory strategy for longterm stability conditions to. Stability q1a r2 stability testing in new drugs and products revised guideline q1b photo stability testing q1c stability testing. Stability testing of apis and fpps who stability guide in trs953 2009 annex 2. Draft regional guidelines on stability testing of active.
Climatic zone the zones into which the world is divided based on the prevailing annual climatic conditions. Vich gl58 stability testing in zones iii and iv step 4. Use stability, correlation with climatic zones and. The stability testing recommendations in this guideline are based on the parent guideline and the who guideline. Measured, calculated and derived data climatic zone measured data calculated data derived data temp. Stability testing of new drug substances and products revision of ich q1a. Definition and storage conditions for the four climatic zones. Q 1 a r2 stability testing of new drug substances and. Stability regulations this segment is a growing collection of laws, guidances and requirements pertaining to the stability function from various nations and recognized global and regional organizations.
Guidance for industry q1ar2 stability testing of new drug substances and products. Note for guidance on stability data package for registration in climatic zones iii. Know different climatic zones by ich in the world for stability conditions including temperate, mediterranean subtropical, hot dry, hot humid tropical and hot. Stability testing of new drug substances,stability testing,new drug substances,ich q1ar2. Cllinatic zone definition i temperate climate ii subtropical and mediterranean climate iii hotdry climate iv a hothumid climate. Zone i was defined to temperate, zone ii subtropical or mediterranean, zone iii hot and dry, and zone iv hot and humid. A very important point in conducting stability studies are the storage conditions. Global climatic zone divisions for stability studies on.
Four climatic zones can be distinguished for the purpose of worldwide stability testing, as follows. The who guideline describes stability testing recommendations, including storage conditions for all four climatic zones. Requirements for stability studies of finished pharmaceutical. General consideration definition and storage conditions for the four climatic zones. Q1ar2 stability testing of new drug substances and. Various guidelines explaining the concept, procedures, and protocols have been developed and issued by international, regional, and national regulatory agencies to help the manufacturers in the generation of valid and acceptable stability data. Ich q1a r2 stability testing of new drug substances and products. As stability testing is a long process, you need to produce real timescale data for as long as the intended shelf life of the product you intend to register it is recommended to run tests for all the climatic zones in. Ich guidelines for stability studies 2 authorstream.
The purpose of stability testing cosmetic products is to ensure that a new or modified product meets the intended physical, chemical and microbiological quality standards as well as functionality and aesthetics when stored under appropriate conditions. The first is a guidance entitled q1f stability data package for registration applications in climatic zones iii and iv the q1f guidance. Paula correia, carla vozone, nastaran sigari, carole evans, eva castro, lilian gonzalo, lee nagao. Stability testing of new drug substance and products, 2003. Scientific and commercial success of a pharmaceutical product can only be ensured with the understanding of the drug. Climatic testing is a type of environmental stress testing that recreates in a controlled setting all environmentalweather conditions a product could conceivably encounter.
Annex 2 stability testing of active pharmaceutical. Five climatic zones can be distinguished for the purpose of worldwide stability testing. The ich harmonised tripartite guideline on stability testing of new drug substances and products was issued on october 27, 1993. While some are legal requirements, others are guidances that can be fulfilled with justified alternative measures, but all are expectations of duly authorized regulatory bodies. Climate zones classification drug stability testing classification of countries according to climatic zones c drug stability testing classification of countries according to climatic zones country climatic zones assigned to country climatic zones assigned to afghanistan i, ii ii kampuchea iv iv. 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. Stability testing methods stability testing is a routine procedure performed on drug substances and products and is employed at various stages of the product development. Accelerated stability testing can be used as a worst case evaluation to uncover the kinds of degradation products potentially found after longterm storage. No intermediate storage condition for stability studies is recommended for climatic zones. Q1ar2 stability testing of new drug substances and products.
Climate zones the design of the stabilitytesting programme should take into account the intended market and the climatic conditions in the area in which the medicinal products will be used. If an assay is to be used for stability testing, its. If the product is intended to be marketed in several climatic zones, it is up to the applicant. Ich stability requirements overcoming the challenges. To harmonise with the longterm storage condition for zones iii and iv. Conducting stability studies recent changes to climatic. Long term stability studies should cover all climatic zones if. Stability testing of pharmaceutical products in a global. Oot and ooe may occur during stability studies all types of stability climatic zones. New dosage forms q1d bracketing and matrixing designs for stability testing of drug substances and drug products q1e evaluation of stability data q1f stability data package for registration in climatic zones iii.