G.L. Fourman, M.V. Mullen, “Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations” Pharmaceutical technology 17(4) 1993
…
アーカイブ: 参考文献
PDA CLEANING AND CLEANING VALIDATION VOL.2 “SAMPLING FOR CLEANING VALIDATION – ANALYTICAL CONSIDERATIONS (2013)
…
ISPE Baseline🄬 Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) (2010)
…
APIC GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHAERMACEUTICAL INGREDIENT PLANTS (2021)
…
PIC/S-GMP, GUIDELINE ON SETTING HEALTH-BASED EXPOSURE LIMITS FOR USE IN RISK IDENTIFICATION IN THE MANUFACTURE OF DIFFERENT MEDICINAL PRODUCTS IN SHARED FACILITIES (2014)
…
PIC/S-GMP, GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEX 15 * Chapter 10 (2015)
…
ICH HARMONISED TRIPARTITE GUIDELINE GOOD MANUFACTURING PRACTICE GUIDELINE IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C R3 APPENDIX3 (1997)
…
毒性学的評価による洗浄バリデーション, 島一己著, 2019
…
橋本 翔, 塩見 真衣 各種除塵対策の除塵効果に関する研究 平成30年度大会（名古屋）学術講演論文集 第７巻 空気質 編
…
WHO Technical Report Series, No.961, Annex 5 (2011)
…
PIC/S GMP, GUIDELINE Part1 (2017)
…
PIC/S GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS
…
Data Integrity and Compliance With CGMP Guidance for Industry
…
Tina Morris, PDA, Maik Jornitz, G-Con, Gabriele Gori, GSK, and Hal Baseman, ValSource, PUPSIT and the Annex 1 Revision, PDA Letter, Aug 29, 2019
…
BEST PRACTICES FOR SUCCESSFUL FILTER INTEGRITY TESTING USING WATER INTRUSION TEST (WIT) METHOD Posted on December 19, 2017, Monica Cardona and Ian Johnson, Pall Life Sciences
…
FilTec 技術情報：精度の高い無菌濾過フィルターの完全性試験手法について：http://www.filtec.co.jp/technical/index-002.html#technical002
…
ECA (European Compliance Academy) Task Force on Contamination Control Strategy, How to Develop and Document a Contamination Control Strategy
…
PDA Technical Report No.90, Contamination Control Strategy Development in Pharmaceutical Manufacturing
…
FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice
…
PIC/S GMP Annex 1, Manufacture of sterile medicinal products
…