ISPE 标准清单

ZT涛

Advanced  Manufacturing (1)	Year	Page
Good Practice Guide: Continuous  Manufacturing of Oral Solid Dosage Forms	2018	180
Advanced  Therapy Medicinal Products (1)	Year	Page
Guide: ATMPs - Autologous Cell Therapy	2021	148
Biotechnology  (2)	Year	Page
Baseline Guide Volume 6:  Biopharmaceutical Manufacturing Facilities	2013	140
Guide: ATMPs - Autologous Cell Therapy	2021	148
Commissioning  & Qualification (4)	Year	Page
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)	Year	Page
Guide: 503B Compounding	2023	122
Containment  (3)	Year	Page
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)	Year	Page
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)	Year	Page
GAMP Good Practice Guide: Manufacturing  Execution Systems	2010	144
GAMP®  (1)	Year	Page
GAMP Good Practice Guide: Manufacturing  Execution Systems	2010	144
Good Manufacturing Practice  (1)	Year	Page
Guide: 503B Compounding	2023	122
Manufacturing  Operations (8)	Year	Page
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)	Year	Page
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)	Year	Page
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)	Year	Page
Good Practice Guide: Packaging, Labeling,  & Warehousing Facilities	2012	112
Quality  Assurance (1)	Year	Page
Guide: 503B Compounding	2023	122
Quality  Control (2)	Year	Page
Good Practice Guide: Quality  Lab Facilities	2012	176
Good Practice Guide: Sampling Pharma  Water, Steam, & Process Gases	2016	122
Quality  by Design (1)	Year	Page
Baseline Guide Vol 5: Commissioning &  Qualification 2nd Edition	2019	212
Regulatory  (3)	Year	Page
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)	Year	Page
Good Practice Guide: Single-Use  Technology	2018	180
Sterile  Products (1)
Baseline Guide Vol 3: Sterile Product  Manufacturing Facilities 3rd Edition	Year	Page
	2018	244
Supply  Chain Management (2)	Year	Page
Good Practice Guide: Cold Chain  Management	2011	140
Good Practice Guide: Single-Use  Technology	2018	180
Sustainability  (1)	Year	Page
Good Practice Guide: Asset Management	2019	116
Sustainable  Facilities, HVAC, & Controlled Environments (6)	Year	Page
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)	Year	Page
Guide: Cleaning Validation Lifecycle -  Applications, Methods, & Controls	2020	236

三岁e06

我全部都有，诶，气死你

小树冲冲

三岁e06 发表于 2023-10-30 13:41
我全部都有，诶，气死你

阿姨                    

梦幻咖啡

资料齐全，谢谢！

胜利者

期待沙发分享

ZT涛

小树冲冲 发表于 2023-10-30 13:53
阿姨

也快收集齐全了

胖胖猴1

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

帝天行道

留图不留种，后面的清自行脑补

zackzong

谢谢楼主分享

成康

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。

三岁e06

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

过路路过

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？

成康

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。

1761696964

Good Practice Guide: Process Gases这个好像2023年10月出了一版新的