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jieudhl

发表于 2023-8-10 08:23:54 | 显示全部楼层 |阅读模式

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看大家关注到了BPOG，发一些文件

A CPV strategy at first stages of monoclonal antibody purification by integrated.pdf

724.11 KB, 下载次数: 89

A Gudie to Integrating CPV and APR 2021.07.pdf

259.81 KB, 下载次数: 83

Continued process verification of legacy products in the biopharmaceutical indus.pdf

1.06 MB, 下载次数: 82

CPV - An Industry Position Paper with Example Plan 2014.pdf

1.03 MB, 下载次数: 78

CPV and the Validation of Informatics Systems November-2018.pdf

677.69 KB, 下载次数: 83

CPV of Legacy Products in the Biopharmaceutical Industry 2017.pdf

1.04 MB, 下载次数: 77

A comprehensive review of BioPhorum standardized extractables testing data Septe.pdf

1.15 MB, 下载次数: 86

Best practices guide for evaluating leachables risk from polymeric single-use sy.pdf

1.73 MB, 下载次数: 108

BPOG-Extractables-Assembly-Family-Template.pdf

110.91 KB, 下载次数: 93

BPOG-Extractables-Component-family-template.pdf

101.13 KB, 下载次数: 83

Extractables testing of polymeric single-use components used in biopharmaceutica.pdf

312.85 KB, 下载次数: 84

Guide-to-the-extractables-test-report-April-2020.pdf

223.21 KB, 下载次数: 79

2015_CMCS_GampferJoerg ppt.pdf

935.72 KB, 下载次数: 64

2018-Elastomer-change-out-justification-for-minimizing-the-removal-of-elastomers.pdf

446.2 KB, 下载次数: 61

2018-Guidelines-for-risk-based-change-over-of-biopharma-mult-product-facilities.pdf

3.69 MB, 下载次数: 76

2018-Microbiological-control-for-affinity-capture-chromatography-processing_-an-.pdf

249.71 KB, 下载次数: 66

A Standardized Risk Assessment Tool and Harmonized Approach for Selection and De.pdf

1.01 MB, 下载次数: 67

Additional Challenges to the New Cleanroom Paradigm.pdf

967.09 KB, 下载次数: 68

An Industry Perspective on Forced Degradation Studies of Biopharmaceuticals：Sur.pdf

1.73 MB, 下载次数: 64

An Industry-Wide Standardized Methodology and Risk Classification Tool for Parti.pdf

296.6 KB, 下载次数: 71

Best practice guide for preparation of cell culture media April 2021.pdf

297.5 KB, 下载次数: 68

Best-practice-on-practice-qualification_-good-distribution-practice-July-2019.pdf

1020.45 KB, 下载次数: 70

Biomanufacturing Technology Roadmap D D Real-Time Release Real-Time Release.pdf

5.38 MB, 下载次数: 67

Biomanufacturing Technology Roadmap Overview.pdf

5.59 MB, 下载次数: 70

Biomanufacturing Technology Roadmap Supply Partnership Management.pdf

5.25 MB, 下载次数: 71

Biomanufacturing technology roadmap：1. Executive summary.pdf

5.12 MB, 下载次数: 61

Biomanufacturing technology roadmap：2. Overview.pdf

5.59 MB, 下载次数: 64

Biomanufacturing technology roadmap：3. Process technologies.pdf

5.55 MB, 下载次数: 69

Biomanufacturing technology roadmap：4. Automated facility.pdf

5.27 MB, 下载次数: 60

Biomanufacturing technology roadmap：5. Modular and mobile.pdf

7.08 MB, 下载次数: 62

Biomanufacturing technology roadmap：6. In-line monitoring and real time release.pdf

5.38 MB, 下载次数: 66

Biomanufacturing technology roadmap：7. Knowledge management.pdf

743.6 KB, 下载次数: 63

Biomanufacturing technology roadmap：8. Supply partnership management.pdf

5.25 MB, 下载次数: 61

Biomanufacturing Technology Roadmap-Automated Facility.pdf

5.27 MB, 下载次数: 69

Biopharmaceutical Industry Position on EMA Guidance and Expectations at Product .pdf

259.01 KB, 下载次数: 58

BP_Bioprocesing-Trends-102016.pdf

12.53 MB, 下载次数: 84

BPOG Biomanufacturing Technology Roadmap.pdf

5.44 MB, 下载次数: 72

BPOG-DPMM-Best-Practice-for-Plant-Assessments-May-2018.pdf

1.57 MB, 下载次数: 65

Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk D.pdf

599.5 KB, 下载次数: 67

Change Management During Lifecycle of Facilities, Utilities and Equipment.pdf

199.4 KB, 下载次数: 64

Container closure integrity control versus integrity testing during routine manu.pdf

48.34 KB, 下载次数: 62

Data-Integrity-IT-Positioning-Paper.pdf

194.61 KB, 下载次数: 61

Data-Integrity-System-Assessment-Template.pdf

319.95 KB, 下载次数: 69

Detection of Cutibacterium Acnes, a High-Risk Aerotolerant Anaerobe Recovered in.pdf

253.68 KB, 下载次数: 59

Environmental-Monitoring-EM-A-harmonized-risk-based-approach-to-selecting-monito.zip

6.45 MB, 下载次数: 74

Guidance on how to write a disaster recovery playbook of the manufacturing envir.pdf

576.1 KB, 下载次数: 60

Guidance ON the Use of Agile in a GXP Environment Companion Document March-2019.pdf

296.18 KB, 下载次数: 61

Guidance on the Use of Agile in a GxP Environment.pdf

251.72 KB, 下载次数: 57

Guide to risk based DMS implementation August 2020.pdf

493.21 KB, 下载次数: 60

Human Performance Investigation root cause analysis October 2020.pdf

343.25 KB, 下载次数: 60

HuP-PDA-Journal-article-October-2015.pdf

2.17 MB, 下载次数: 57

Introduction to x-ray and gamma sterilization methods August 2021.pdf

498.31 KB, 下载次数: 51

Investigation and Root Cause Analysis Best Pracices 2020.10.pdf

343.25 KB, 下载次数: 62

Isolator Glove Management：Evaluation of Regulatory Guidance and Framework of Re.pdf

1.23 MB, 下载次数: 54

IT Controls for ‘Infrastructure as a Service’ in the Biopharmaceutical Industry.pdf

163.24 KB, 下载次数: 51

Joint Audit Program Pilot program summary report January 2021.pdf

657.47 KB, 下载次数: 51

Justification of small-scale models - industry perspective May 2021.pdf

2.66 MB, 下载次数: 63

Lonza Error Prevention System (EPS) – Changing Human Performance in Pharmaceuti.pdf

826.62 KB, 下载次数: 56

Maintenance-Frequency-Optimization-Tools-MAY-2017-Proof-4.pdf

1.02 MB, 下载次数: 54

Microbial control：Microbial monitoring for biological drug substance manufactur.pdf

625.73 KB, 下载次数: 66

Mold control and detection in biological drug substance manufacturing facilities.pdf

435.98 KB, 下载次数: 60

Plug-and-Play Computerized Systems Validation Strategy 2021.07.pdf

370.49 KB, 下载次数: 54

Raw-material-A-holistic-approach-to-raw-material-risk-assessments-through-indust.zip

119.96 KB, 下载次数: 63

Risk assessment of cells used in early development September 2021.pdf

258.89 KB, 下载次数: 62

Risk assessment of traditional culture-based microbiological tests requiring con.pdf

249.82 KB, 下载次数: 59

Serialization – Challenges and Good Practices in Packaging Operations Based on .pdf

3.34 MB, 下载次数: 58

Single-use system audit guide September 2021.pdf

217.24 KB, 下载次数: 62

Single-use-change-notification-Guidance-and-implementation-tool-kit.zip

211.36 KB, 下载次数: 57

Strategy Roadmap for the Implementation of A Risk-Based Approach to Pre-use Post.pdf

203.65 KB, 下载次数: 57

Supplier Change Notifications (SCNs) Change Areas and Requirements 2021.12.pdf

249.63 KB, 下载次数: 57

Trace element variation of soy hydrolysates used in biopharmaceutical manufactur.pdf

1.11 MB, 下载次数: 55

Training for Biotech Manufacturing Operator Competence.pdf

217.92 KB, 下载次数: 60

TRM Harvest Clarification version 2.0 January 2021.pdf

260.79 KB, 下载次数: 57

TVR-Determining-testing-validation-and-release-requirements-for-single-use-syste.zip

5.29 MB, 下载次数: 69

Universal Data Integrity System Assessment Template in the Biopharmaceutical Industry.pdf

319.95 KB, 下载次数: 62

URS for Optimized Container Closure Integrity Testing Equipment November 2020.pdf

182.17 KB, 下载次数: 61

URS for Small Flexible Fillers May-2018.pdf

148.97 KB, 下载次数: 58

using-risk-management-to-put-the-design-in-qbd-william-bennett.pdf

513.97 KB, 下载次数: 56

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汉字太少

发表于 2023-8-10 08:31:38 | 显示全部楼层

这么多，一个都看不懂

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勇仔qq

发表于 2023-8-10 09:11:41 | 显示全部楼层

汉字太少发表于 2023-8-10 08:31
这么多，一个都看不懂

瞎说什么大实话

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隐月

发表于 2023-8-10 09:16:06 | 显示全部楼层

感谢分享

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隐月

发表于 2023-8-10 09:19:34 | 显示全部楼层

能否发一下压缩包呀

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jianglimin1980

发表于 2023-8-29 15:09:07 | 显示全部楼层

感谢分享！！！

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allen.xu

发表于 2023-9-8 12:01:46 | 显示全部楼层

赞一个，牛！！

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18702141731

发表于 2023-9-8 12:25:46 | 显示全部楼层

看个目录都挺费劲的

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李聪聪

发表于 2023-9-16 22:21:43 | 显示全部楼层

不错的资源

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baixuedajie

发表于 2024-5-27 13:16:31 | 显示全部楼层

感谢分享

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小飞象ovo

发表于 2024-12-13 15:11:09 | 显示全部楼层

thanks for sharing.

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