Zone IV. Packaging more protective than that used for Zone II countries may be needed. Long Term Testing Conditions. 30ºC/75%RH long-term stability data on at least one package configuratio… Such testing is provided for in ICH Q1A [3]. Zone IVb. ICHのガイドラインにはGlossary（用語）が記載されている場合があります。ガイドライン上で用いられる用語について説明、定義している部分になります。Accelerated testingは日本語で加速試験と呼ばれ、品質が悪化しやすい、高温多湿条件での安定性試験のことを指します。 For products marketed in Zone IV countries which require 30ºC/75% RH or 30ºC/65%RH stability data for registration renewal or to support post-approval changes, the development team should assess the available stability data. This paper provides such a list in Tables 1-3, basing it on the 2009 WHO stability guidance. Drug substances manufactured or used by many firms typically are not exposed to Zone IV storage temperatures for any significant period of time. Bob is a member of the steering committee of the Pharmaceutical Cold Chain Interest Group of PDA and served as an editor of Technical Report 39, “Cold Chain Guidance for Medicinal products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment.” While he was with the FDA, Bob was a chemistry reviewer in the Division of Medical Imaging, Surgical, and Dental Reproductive and Urologic Drug Products and chemistry review team leader in the Division of Neuropharmacological Drug Products. In that capacity, he was the editor of the 1998 Draft Stability Guidance. This confusion has resulted from multiple messages from groups such as the International Conference on Harmonization (ICH), the World Health Organization (WHO), regional associations of nations, and several individual countries themselves. Drug substances (active pharmaceutical ingredients) are not explicitly covered in this paper. If a drug product is sufficiently stable, then 30ºC/75%RH represents a single long-term stability condition TESTINGfor all global submissions. There have also been questions of how, exactly, it can be determined whether a country is a Zone IV country or not. 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 which sub-zone it was in [7]. 30ºC long-term stability data on at least one package configuration for parenteral products. 30ºC ± 2ºC. Since the WHO has decided to let each country determine its own status without providing a clear cut set of temperature/humidity criteria to differentiate one climatic zone from another, a list of countries with assignments is needed. A Publication of Table 1 lists those countries for which 25ºC/60%RH is recommended in the WHO guide. Australia, therefore, does not require Zone IV stability data. The entry for Israel in the WHO guidance provides for a long-term stability condition of 30°C/70% or 30°C/75% RH, but it is our understanding that Israeli regulators consider it to be a Zone II country and are working with WHO to change its entry in the guidance. Zone III. 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]. 新投与経路医薬品等の安定性試験成績の取扱いに関するガイドライン: ステップ5: 1997.5.28 （原文）Stability Testing for New Dosage Forms: ステップ5 : Q1D : 原薬及び製剤の安定性試験へのブラケッティング法及びマトリキシング法の適用: ステップ5: 2002.7.31 The entry for Canada in the WHO guidance lists the long-term stability condition as 30ºC/65%RH only [8]. http://www.ich.org/LOB/media/MEDIA3124.pdf, http://pharmalytik.com/images/stories/PDF/asean%20stability%20guidelines%20-%2022%20feb%202005.pdf, http://www.who.int/medicines/areas/quality_safety/quality_assurance/ConsultStabstudies/en/, http://www.who.int/medicines/publications/pharmprep/pdf_trs953.pdf#page=101, http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/qual/q1a(r2)-eng.php, http://www.tga.gov.au/pmeds/argpmap14.pdf, Regulatory Strategy for Long-Term Stability Conditions to Support Submission in Zone IV Countries. Teams will also have to determine when to begin the primary stability studies at Zone IV conditions. See our other sites ». 12 Months. ǥ�z�4�Y[m_�Wt�J��+ݴ�sӨ����/�ŅX���m��ћ�����s�F���|c�YJ4nͬ����%�=����1p���S6pt3_u�*%)�5��&�k Therefore we have placed Canada in Table 1. 45% rH ± 5% rH. Bob received his Ph.D. in Medicinal Chemistry from the University of Michigan in 1981. Plus, get special offers and The exclusion is not based on the product itself but on whether it is packaged in an impermeable container and intended for room temperature storage. Table 3 lists countries for which 30ºC/75%RH is recommended based on climatic information obtained by WHO from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Hot humid/tropical zone. ��t�2ퟵ��#�#}���$�]V�^��jx�)�zX�ֈ���5�!�x������-�2H/��B��Mu��_�k�g��\I�ԕ��M������:k��]���u�_B��R(Y+i�3�1���-��WU�U���쑫���W.�$8�/���x��dm3TM=��J��V�1��ٺ�(���8?G^�\?V|�hT.K��P8 ��;8��QQ�8� ��VYR��J&8'��d.
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