蒲公英 - 制药技术的传播者 GMP理论的实践者

标题: ISPE 标准清单 [打印本页]

作者: ZT涛    时间: 2023-10-30 12:05
标题: ISPE 标准清单
Advanced  Manufacturing (1)YearPage
Good Practice Guide: Continuous  Manufacturing of Oral Solid Dosage Forms
2018
180
Advanced  Therapy Medicinal Products (1)YearPage
Guide: ATMPs - Autologous Cell Therapy
2021
148
Biotechnology  (2)YearPage
Baseline Guide Volume 6:  Biopharmaceutical Manufacturing Facilities
2013
140
Guide: ATMPs - Autologous Cell Therapy
2021
148
Commissioning  & Qualification (4)YearPage
Good Practice Guide: C&Q of Pharma  Water & Steam Systems 2nd Edition
2014
120
Good Practice Guide: Decommissioning  Pharma Equipment & Facilities
2017
132
Good Practice Guide: Controlled  Temperature Chambers 2nd Edition
2021
134
Baseline Guide Vol 5:  Commissioning & Qualification 2nd Edition
2019
212
Compounding  (1)YearPage
Guide: 503B Compounding
2023
122
Containment  (3)YearPage
Good Practice Guide: Assessing  Particulate Containment 2nd Edition
2012
104
Good Practice Guide: Containment for  Potent Compounds
2022
258
Good Practice Guide: Asset Management
2019
116
Critical  Utilities (8)YearPage
Baseline Guide Vol 4: Water & Steam  Systems 3rd Edition
2019
280
Good Practice Guide: C&Q of Pharma  Water & Steam Systems 2nd Edition
2014
120
Good Practice Guide: Ozone Sanitization  of Pharma Water Systems
2012
144
Good Practice Guide: Membrane-Based WFI  Systems
2022
196
Good Practice Guide: Critical Utilities  GMP Compliance
2020
100
D/A/CH Affiliate: WFI Handbook (English  Translation)
2021
88
Good Practice Guide: Process Gases
2011
148
Good Practice Guide: Sampling Pharma  Water, Steam, & Process Gases
2016
122
Data  Integrity (1)YearPage
GAMP Good Practice Guide: Manufacturing  Execution Systems
2010
144
GAMP®  (1)YearPage
GAMP Good Practice Guide: Manufacturing  Execution Systems
2010
144
Good Manufacturing Practice  (1)YearPage
Guide: 503B Compounding
2023
122
Manufacturing  Operations (8)YearPage
Baseline Guide Vol 2: Oral Solid Dosage  Forms 3rd Edition
2016
240
Good Practice Guide: Continuous  Manufacturing of Oral Solid Dosage Forms
2022
142
Baseline Guide Volume 6:  Biopharmaceutical Manufacturing Facilities
2013
140
Guide: ATMPs - Autologous Cell Therapy
2021
148
GAMP Good Practice Guide: Manufacturing  Execution Systems
2010
144
Good Practice Guide: Maintenance 2nd  Edition
2021
132
Good Practice Guide: Equipment  Reliability
2020
140
Baseline Guide Vol 3: Sterile Product  Manufacturing Facilities 3rd Edition
2018
244
Microbiological  & Viral Contamination Control (17)YearPage
Baseline Guide Vol 2: Oral Solid Dosage  Forms 3rd Edition
2016
240
Baseline Guide Vol 4: Water & Steam  Systems 3rd Edition
2019
280
Guide: Cleaning Validation Lifecycle -  Applications, Methods, & Controls
2020
236
Baseline Guide Volume 6:  Biopharmaceutical Manufacturing Facilities
2013
140
Good Practice Guide: Quality Lab  Facilities
2012
176
Good Practice Guide: Ozone Sanitization  of Pharma Water Systems
2012
144
Good Practice Guide: Membrane-Based WFI  Systems
2022
196
Good Practice Guide: Heating,  Ventilation, & Air Conditioning (HVAC)
2009
288
Good Practice Guide: Assessing  Particulate Containment 2nd Edition
2012
104
Good Practice Guide: Containment for  Potent Compounds
2022
258
D/A/CH Affiliate: WFI Handbook (English  Translation)
2021
88
Good Practice Guide: Process Gases
2011
148
Good Practice Guide: HVAC  & Process Equipment Air Filters
2019
124
Good Practice Guide: Asset Management
2019
116
Baseline Guide Vol 3: Sterile Product  Manufacturing Facilities 3rd Edition
2018
244
Japan Affiliate: Pest Control Manual  (English Translation)
2018
180
Good Practice Guide: Sampling Pharma  Water, Steam, & Process Gases
2016
122
Oral  Solid Dosage (2)YearPage
Baseline Guide Vol 2: Oral Solid Dosage  Forms 3rd Edition
2016
240
Good Practice Guide: Continuous  Manufacturing of Oral Solid Dosage Forms
2022
142
Packaging  (1)YearPage
Good Practice Guide: Packaging, Labeling,  & Warehousing Facilities
2012
112
Quality  Assurance (1)YearPage
Guide: 503B Compounding
2023
122
Quality  Control (2)YearPage
Good Practice Guide: Quality  Lab Facilities
2012
176
Good Practice Guide: Sampling Pharma  Water, Steam, & Process Gases
2016
122
Quality  by Design (1)YearPage
Baseline Guide Vol 5: Commissioning &  Qualification 2nd Edition
2019
212
Regulatory  (3)YearPage
Baseline Guide Vol 4: Water & Steam  Systems 3rd Edition
2019
280
Good Practice Guide: Critical Utilities  GMP Compliance
2020
100
Baseline Guide Vol 5: Commissioning &  Qualification 2nd Edition
2019
212
Single  Use Technologies & Disposables (1)YearPage
Good Practice Guide: Single-Use  Technology
2018
180
Sterile  Products (1)
Baseline Guide Vol 3: Sterile Product  Manufacturing Facilities 3rd EditionYearPage
2018
244
Supply  Chain Management (2)YearPage
Good Practice Guide: Cold Chain  Management
2011
140
Good Practice Guide: Single-Use  Technology
2018
180
Sustainability  (1)YearPage
Good Practice Guide: Asset Management
2019
116
Sustainable  Facilities, HVAC, & Controlled Environments (6)YearPage
Good Practice Guide: Cold Chain  Management
2011
140
Good Practice Guide: Heating,  Ventilation, & Air Conditioning (HVAC)
2009
288
Good Practice Guide: Assessing  Particulate Containment 2nd Edition
2012
104
Good Practice Guide: Containment for  Potent Compounds
2022
258
Good Practice Guide: Controlled  Temperature Chambers 2nd Edition
2021
134
Good Practice Guide: HVAC  & Process Equipment Air Filters
2019
124
Validation  (1)YearPage
Guide: Cleaning Validation Lifecycle -  Applications, Methods, & Controls
2020
236


作者: 三岁e06    时间: 2023-10-30 13:41
我全部都有,诶,气死你
作者: 小树冲冲    时间: 2023-10-30 13:53
三岁e06 发表于 2023-10-30 13:41
我全部都有,诶,气死你

阿姨                    
作者: 梦幻咖啡    时间: 2023-10-30 14:00
本帖最后由 梦幻咖啡 于 2023-10-30 14:05 编辑

资料齐全,谢谢!
作者: 胜利者    时间: 2023-10-30 15:00
期待沙发分享
作者: ZT涛    时间: 2023-10-30 15:19
小树冲冲 发表于 2023-10-30 13:53
阿姨

也快收集齐全了
作者: 胖胖猴1    时间: 2023-10-30 15:19
三岁e06 发表于 2023-10-30 13:41
我全部都有,诶,气死你

你全看了吗
作者: 帝天行道    时间: 2023-10-30 15:29
留图不留种,后面的清自行脑补
作者: zackzong    时间: 2023-10-30 22:39
谢谢楼主分享
作者: 成康    时间: 2023-11-1 15:40
三岁e06 发表于 2023-10-30 13:41
我全部都有,诶,气死你

你没有把他气到,倒是气到我了。
作者: 三岁e06    时间: 2023-11-1 15:59
成康 发表于 2023-11-1 15:40
你没有把他气到,倒是气到我了。

哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈
作者: 过路路过    时间: 2023-11-1 16:01
三岁e06 发表于 2023-10-30 13:41
我全部都有,诶,气死你

503B Compounding
这个也有?
作者: 成康    时间: 2023-11-1 16:20
三岁e06 发表于 2023-11-1 15:59
哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈哈

你就不打算把这仇这怨给消除一下嘛,圈子就这么大,抬头不见低头见的,哪天我碰到你了,也不好。
553977405(qq),你看着办吧。
作者: 1761696964    时间: 2024-1-23 14:36
Good Practice Guide: Process Gases这个好像2023年10月出了一版新的
作者: 张忘忘忘    时间: 2025-9-10 15:15
三岁e06 发表于 2023-10-30 13:41
我全部都有,诶,气死你

老师,求一份
作者: 张忘忘忘    时间: 2025-9-10 15:16
ZT涛 发表于 2023-10-30 15:19
也快收集齐全了

老师,求一份
作者: 三岁e06    时间: 5 天前
张忘忘忘 发表于 2025-9-10 15:15
老师,求一份

不行不行不行




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