I. GMP Guideline for Drug Products: Text - NIHS

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添付資料 4 GMP Guideline for Drug ProductsPreface and AcknowledgmentIn the Welfare and Labor Science Research in 2003 “Study related to the conceptof latest quality system and techniques for drugs” (chief study director: Yukio Hiyama, Ph.D.), our study group reported “A Proposal for Drug GMP Guidance.” For preparation ofthis guidance, “Draft Drug Product GMP Guideline” by Japanese PharmaceuticalManufacturer’s Association” was used as a reference, and a lot of helpful comments weregiven by those concerned in the industry.In 2004 we issued “A Proposal for Drug GMP Guidance” to ask for publiccomments, and prepared this research report “GMP Guideline for Drug Products” basedon a lot of ideas given by the GMP Committee of the Federation of PharmaceuticalManufacturers’ Associations of Japan and Parenteral Drug Association Japan Chapter(PDA Japan), as well as companies and individuals.Although some people may consider the roles of GMP for Drug Products asdifferent from those presented in this guideline, we would appreciate it very much ifreference is made to the rationale for our ideas given in “II. Explanation” of this guideline.We would like to express our deep appreciation to all who gave us helpful information.We look forward to contribution of this guideline to voluntary activities ofcompanies in relation to GMP.March, 2006Study Group for GMP Guideline for Drug Products2
添付資料 4 GMP Guideline for Drug ProductsIntroductionThe regulatory requirements for the manufacturing control and quality control atmanufacturing sites, i.e. the minimum standards to be followed, which may accompanyenforcement measures including improvement orders when unconformity occurs, are thefollowing: “Ministerial Ordinance for Good Manufacturing Practice for Drugs andQuasi-drugs” (MHLW Ministerial Ordinance No. 179, 2004, hereinafter referred to as“GMP Ministerial Ordinance for Drugs and Quasi-drugs”) that was revised and issuedaccording to the revised Pharmaceutical Affairs Law to be effective on April 2005, and theRegulations for Buildings and Facilities for Pharmacies etc. (MHW Ministerial OrdinanceNo. 2, 1961, hereinafter referred to as “Regulations for Buildings and Facilities”). Onthe other hand, beyond such compliance with the regulatory requirements, further effortsfor continuous improvement are required for actual implementation of manufacturingcontrol and quality control of drug products, while incorporating voluntarily andpositively ICH Q7A Guideline (hereinafter referred to as “Q7A”), and requirementsshown in standards and guidance in Europe and USA, as well as control methods that arebeing globally and commonly acknowledged with the progress of knowledge andtechnology.From the view point of supporting such efforts, in regard to general matters onmanufacturing control and quality control of drug products (except for specified drugproducts such as sterile drugs and biological products, etc.), this “GMP Guideline for DrugProducts” was prepared to provide as specifically as possible the control methods that arerelated to the requirements of the GMP Ministerial Ordinance for Drugs and Quasi-drugsand the Regulations for Buildings and Facilities as well as the “Ministerial Ordinance forGood Quality Practice for Drugs, Quasi-drugs, Cosmetics and Medical Devices” (MHLWMinisterial Ordinance No. 136, 2004, hereinafter referred to as “GQP MinisterialOrdinance”) but are not legally required or not clearly specified as requirements, and thatneed to be voluntarily addressed according to current knowledge, etc. The format of aguideline makes it possible to flexibly deal with future necessity of review in this fieldwith significant progress in knowledge and technology.3
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