Tag: QUALIFICATION-CERTIFICATE

Water System (PW/WFI) – Point of Use for LVP – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment Name: Water System (PW/WFI) – Point of Use for LVP Equipment Identifier: [Equipment Identifier] Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Utilities Qualification Summary DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes Requalification Frequency: 12 Months Protocol References Protocol Reference:…

Capsule/Blister Filler for DPI – Qualification Certificate Template

Qualification Certificate Equipment: Capsule/Blister Filler for DPI Subcategory: NDDS – Inhaled NDDS Powders (Engineered Particles) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement…

Depyrogenation Tunnel (if glass bottles) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Depyrogenation Tunnel Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Qualification Status DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Dates: [Execution Dates] Calibration…

Spray Dryer (Respirable Particles) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Spray Dryer (Respirable Particles) Subcategory: NDDS – Inhaled NDDS Powders (Engineered Particles) Area: R&D/Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Protocol References: [Protocol Reference 1], [Protocol Reference 2] Execution…

Jet Mill / Spiral Mill – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Jet Mill / Spiral Mill Subcategory: NDDS – Inhaled NDDS Powders (Engineered Particles) Area: R&D/Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference]…

Pouch Packaging & Seal Integrity Tester – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment: Pouch Packaging & Seal Integrity Tester Subcategory: NDDS – Transdermal Microneedles / Advanced Patches Area: Packaging Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol References: [Protocol…

CIP Skid (Sterile/LVP) – Qualification Certificate Template

Qualification Certificate Equipment: CIP Skid (Sterile/LVP) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production/Cleaning Equipment Identifier [Equipment Identifier] Protocol References [Protocol References] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification Statement [Overall Qualification…

Die Cutting / Punching Machine – Qualification Certificate Template

Qualification Certificate Equipment: Die Cutting / Punching Machine Subcategory: NDDS – Transdermal Microneedles / Advanced Patches Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification…

Laminator / Backing Attachment Unit – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment Name: Laminator / Backing Attachment Unit Subcategory: NDDS – Transdermal Microneedles / Advanced Patches Area: Production Qualification Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification (PQ): Yes Qualification…

Case Packer – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Case Packer Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Packaging/Secondary Qualification Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification (PQ): Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol…