文献一覧: 13444891 (ISSN) - Ceek.jp Altmetrics

Conformity of drug products to their specifications alone is not sufficient to assure the quality of drugs to be administered to human subjects. In many European and North American countries, the necessity of validation of the drug manufacturing processes has been discussed and these countries have incorporated such validation into their regulation of drug products. Validation is now recognized as a global standard and has become an essential requirement for drug manufacture. For sterile drug products, specific methodology for conducting the validation has been established and accepted internationally. Regarding solid drug products for oral administration, however, there have been only a small number of studies on the validation of manufacturing processes and many drug manufacturers have difficulty in deciding how to carry out validation for oral solid preparations. Based on experience in GMP (Good Manufacturing Practice) inspection, the author investigated suitable methodology for the validation of ethical drugs, OTC (over-the-counter) drugs, and natural drug preparations/extract products in oriental medicine formulation. The results of the study were published as Osaka Prefecture's “Guidelines for Validation by Individual Drug Formulatron Groups,” which have facilitated the spread of validation without imposing a great burden on manufacturers. In this report, the author would like to explain the administrative background and the fundamental concept of the study.

2018-03-17 20:49:09
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1 0 0 0 OA 培地充てん試験法の許容値と充てん本数および製品品質保証レベル

著者: 川村邦夫阿部寛
出版者: 一般社団法人日本PDA製薬学会
雑誌: 日本PDA学術誌 GMPとバリデーション (ISSN:13444891)
巻号頁・発行日: vol.4, no.2, pp.134-140, 2002 (Released:2006-07-18)
参考文献数: 7

It is no doubt that media fill (simulation) test is the best method to evaluate aseptic processing. However, there are some problems concerning the acceptable criteria of “a contamination rate of less than 0.1% with 95% confidence limit”, which is specified in official compendia, such as JP,USP, EU GMP, WHO GMP, and ISO 13408 part 1 (General). In performing the media fill test, critical issues in performing media fills are the number of fills. Statistical validity of the observed contamination rate for the process has not been well explained hitherto. Problems associated with the “number” of criteria may not necessarily be treated with statistics, and personnel training and operation are sometimes major factors to cause contamination. However, dogma of “a contamination rate of less than 0.1% with 95% confidence limit” should be discussed further. Operation characteristic curves, which show the relationship between percent defectives and acceptance probability, clearly indicate that the more the number of fills, the higher the acceptable probability of contaminated units becomes in the range of contamination rate less than 0.1%. This means that the larger number of fills accept the worse average quality at the range of percent defectives less than 0.1%. According to a table of ISO 13408-1 (1998), which shows the relationship between the number of fills and the number of acceptable contaminated units, 10 positive units are accepted by 16970 fills' as the rate of contaminated units are less than 0.1% with a 95% confidence limit. However, the 95% confidential range of 4 positive units in 16970 fills is calculated to be 1/1970-6/16970. This means that zero (0) positive unit in 16970 fills, that is sterile prduct, is out-of control with a 95% confidence level. Even though the product meets the requirement of “less than 0.1% with a 95% confidence limit”, zero contamination unit in 16970 fills or asepsis must be very rare case. It means that sterile products become out-of-control according to the existing criteria. It is recommended that the dogmatic criteria such as less than 0.1% with 95% confidence limit should be revised. An example of a proposed new criteria is expressed as follows: “The result of media fill should show that the aseptic processing is consistently within the control limit (with a confidence limit of 95%) by using 3000 or more fills, and show the asepsis of the process or the validity of sterility of the product” in stead of “less than 0.1% with a 95% confidence limit.”

2018-03-16 19:42:43
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1 0 0 0 OA 無菌製剤の直接容器として用いるプラスチック中の微粒子について

著者: 榎並鈴子齋藤泉
出版者: 一般社団法人日本PDA製薬学会
雑誌: 日本PDA学術誌 GMPとバリデーション (ISSN:13444891)
巻号頁・発行日: vol.4, no.2, pp.127-133, 2002 (Released:2006-07-18)
参考文献数: 9

For decreasing particulate matter in sterile products, it is important to find the cause of the particulate contamination by containers as well as drugs. Particulate matter in laminated aluminum film, which is one of the multiple materials to be useful for the container of drugs, was investigated by various methods. It was found that the number of particles in the water increased with time by the particle counter when water was filled in a bag of laminated aluminum film. The number of the generated particles from the bag left for several hours exceeded that of the bag shaken sixty times. Besides, many white particles were detected under the microscope by filtrating water. The white particles weren't observed from the polyethylene film alone before lamination. And white particles was observed irrespective of treatment of heat-seal. Therefore, it was supposed lamination process was the cause of the particle formation. The number of particles in heat-sealed bag increased about twice as many as the number of particles in non-heat-seal bag (sealed by adhesive tape). Therefore, the treatment of heat-seal was also cause of the particle formation. In either case, film was held under high temperature and high pressure. Moreover, analyses of white particles showed that main ingredient in particles was same with an ingredient in polyethylene film which was soluble in ethanol. Therefore, it was presumed that the condition of high temperature and pressure caused the particle formation from an impurity in polyethylene, and particles appeared in water.

2018-03-16 19:42:26
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1 0 0 0 OA ヘルスケア製品 (医薬品・体外診断薬・医療用具) の無菌操作法におけるろ過滅菌

著者: 曲田純二
出版者: 一般社団法人日本PDA製薬学会
雑誌: 日本PDA学術誌 GMPとバリデーション (ISSN:13444891)
巻号頁・発行日: vol.4, no.2, pp.121-126, 2002 (Released:2006-07-18)
参考文献数: 5

Regulatory agencies in Japan, US and EU have been requiring validation for sterilizing filtration as part of aseptic processing to pharmaceutical industry. ISO 13408 offers guidance to filter users concerning general requirements for set up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. ISO/TC 198/WG9 has been working for definition of requirements for filter selection, fluid specific selection criteria, filtration process, system design, routine process, documentation, maintenance &change control and operator training. At present, it is a step of Draft International Standard.

2018-03-16 19:42:14
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1 0 0 0 OA 医薬品の滅菌保証における BIER(生物指標抵抗性評価装置) の有用性について─注射剤滅菌プロセスのバリデーションへの活用

著者: 蒲川拓治
出版者: 一般社団法人日本PDA製薬学会
雑誌: 日本PDA学術誌 GMPとバリデーション (ISSN:13444891)
巻号頁・発行日: vol.4, no.2, pp.99-106, 2002 (Released:2006-07-18)
参考文献数: 27

In the development or validation of sterilization process for terminally sterilized parenteral drugs, biological indicators (BIs) are used to evaluate the effectiveness of sterilization. Accurately determining the heat resistance of BIs (D value) in parenrteral solution is extremely important because the D value varies due to variations in the chemical composition of parenteral solutions. The steam BIER vessel can rigidly control the process variables such as exposure temperature and time and provide reproducible physical test conditions. It is possible to heat the BI suspension in capillary tube or small container with short time for come-up and cool-down by using the steam BIER vessel. Because of this advantage, the steam BIER vessel is useful for determination of the D value in parenteral solution. The steam BIER vessel can solve the problem concerning accuracy and procedures of determining the D value in parenteral solution and contribute to perform the high level sterilization process validation for parenteral drugs.

2018-03-16 19:42:00
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1 0 0 0 OA 日本 PDA 2001年年次報告

出版者: 一般社団法人日本PDA製薬学会
雑誌: 日本PDA学術誌 GMPとバリデーション (ISSN:13444891)
巻号頁・発行日: vol.4, no.1, pp.73-75, 2002 (Released:2006-07-28)

2018-03-15 20:41:17
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1 0 0 0 OA QC ラボの Part 11 対応の一事例

著者: 兼子明美
出版者: 一般社団法人日本PDA製薬学会
雑誌: 日本PDA学術誌 GMPとバリデーション (ISSN:13444891)
巻号頁・発行日: vol.4, no.1, pp.52-55, 2002 (Released:2006-07-28)

Requirements regarding electronic records and signatures were published in the United States Federal Register 21 CFR Part 11 in August 1997. These requirements regulate the control of records and signatures and associated security issues in order to respond to the movement towards paperless systems. In the QC lab, printouts from analytical equipment are often treated as raw data and especially for analytical equipment which are computer controlled, where the output is received via electronic media, compliance with the requirements of 21 CFR Part 11 is required to assure the output results. Taking QC lab circumstances into account and aiming towards compliance with 21 CFR Part 11, the preparations and planning, items for investigation and audit preparations are considered.

2018-03-15 20:33:44
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1 0 0 0 OA バイオ医薬品開発におけるメンブレンによるウィルス除去工程,DNA 除去工程のスケールアップ時の留意点

著者: 小田昌宏
出版者: 一般社団法人日本PDA製薬学会
雑誌: 日本PDA学術誌 GMPとバリデーション (ISSN:13444891)
巻号頁・発行日: vol.4, no.1, pp.26-34, 2002 (Released:2006-07-28)
参考文献数: 20
被引用文献数: 1

Development of biopharmaceutical products can be accelerated by proper selection and application of membranes used during product and process development. This Report will discuss scalability, active product transmission and, filterability focusing on virus removal and DNA removal. Also, it will describe, how proper selection of test filters can eliminate or reduce further testing at pilot and production scales, thus reducing time to submission and marketing of the drug product.

2018-03-15 20:26:54
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1 0 0 0 OA 高生理活性物質の製造施設における封じ込め

著者: 山上伸一竹俣昌利溝上宏
出版者: 一般社団法人日本PDA製薬学会
雑誌: 日本PDA学術誌 GMPとバリデーション (ISSN:13444891)
巻号頁・発行日: vol.4, no.1, pp.11-17, 2002 (Released:2006-07-28)
参考文献数: 7
被引用文献数: 1

We are engaging the engineering and construction of many pharmaceutical factories, and facing increasing demand for properly treating the substances with the high pharmacological activity or toxicity. After the agreement of ICH Q7A API Guideline, the discussions on several issues including the containment of hazardous substances were raised broadly. Clarifying the requirement for the containment and the provision against the cross contamination was found very difficult. Issues and steps of countermeasures to establish the basis of containment facility obtained through the experience of the engineering and construction of containment facility is described in this report.