Content focuses on process equipment, the design of facilities, and utility systems that support the critical physical and chemical requirements of drug products, in addition to other aspects of the product specification. Topics include design and construction/installation, commissioning and qualification, operation and maintenance, controls, and automation.
Related Guidance Documents
Advanced Manufacturing (1)
Advanced Therapy Medicinal Products (1)
Biotechnology (2)
Commissioning & Qualification (4)
Compounding (1)
Containment (3)
Critical Utilities (8)
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition
- Good Practice Guide: Ozone Sanitization of Pharma Water Systems
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Critical Utilities GMP Compliance
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: Process Gases
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Data Integrity (1)
Good Manufacturing Practice (1)
Manufacturing Operations (8)
- Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
- Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
- Baseline Guide Volume 6: Biopharmaceutical Manufacturing Facilities
- Guide: ATMPs - Autologous Cell Therapy
- GAMP Good Practice Guide: Manufacturing Execution Systems
- Good Practice Guide: Maintenance 2nd Edition
- Good Practice Guide: Equipment Reliability
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
Microbiological & Viral Contamination Control (17)
- Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- Baseline Guide Volume 6: Biopharmaceutical Manufacturing Facilities
- Good Practice Guide: Quality Lab Facilities
- Good Practice Guide: Ozone Sanitization of Pharma Water Systems
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (HVAC)
- Good Practice Guide: Assessing Particulate Containment 2nd Edition
- Good Practice Guide: Containment for Potent Compounds
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: Process Gases
- Good Practice Guide: HVAC & Process Equipment Air Filters
- Good Practice Guide: Asset Management
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
- Japan Affiliate: Pest Control Manual (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Oral Solid Dosage (2)
Quality Assurance (1)
Quality Control (2)
Quality by Design (1)
Regulatory (3)
Single Use Technologies & Disposables (1)
Sterile Products (1)
Supply Chain Management (2)
Sustainability (1)
Sustainable Facilities, HVAC, & Controlled Environments (6)
- Good Practice Guide: Cold Chain Management
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (HVAC)
- Good Practice Guide: Assessing Particulate Containment 2nd Edition
- Good Practice Guide: Containment for Potent Compounds
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Good Practice Guide: HVAC & Process Equipment Air Filters
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