| 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 |
|手机版|蒲公英|ouryao|蒲公英
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发表于 2023-10-30 12:05:14
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