Tag: QUALIFICATION-CERTIFICATE

Particle Size Classification System (Sieves/Air classifier) – Qualification Certificate Template

Qualification Certificate Equipment: Particle Size Classification System (Sieves/Air Classifier) Subcategory: NDDS – Microspheres & Microcapsules Area: R&D/Production Equipment Identifier [Equipment Identifier] Protocol References [Protocol References] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification…

Terminal Sterilization Load Carts/Racks – Qualification Certificate Template

Qualification Certificate Equipment: Terminal Sterilization Load Carts/Racks Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification Statement [Overall…

Emulsification System (Inline) – Qualification Certificate Template

Qualification Certificate Equipment: Emulsification System (Inline) Subcategory: NDDS – Microspheres & Microcapsules Area: R&D/Production Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Dates: [Execution Dates] Calibration Status: [Calibration Status] Qualification Flags: Design Qualification (DQ): Yes Installation Qualification (IQ): Yes…

Vision System – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Vision System Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: Packaging/Inspection Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Dates: [Execution…

Terminal Sterilization Autoclave (LVP) – Qualification Certificate Template

Qualification Certificate Equipment: Terminal Sterilization Autoclave (LVP) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) 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 [Overall Qualification…

Leak Test Machine (Implant Packaging) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment Name: Leak Test Machine (Implant Packaging) Equipment Identifier: [Equipment Identifier] Subcategory: Implants (Drug-Eluting / Biodegradable) Area: Production/QC Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Protocol Reference: [Protocol Reference] Execution Dates:…

Explosion-Proof HVAC System – Qualification Certificate Template

Qualification Certificate Equipment: Explosion-Proof HVAC System Subcategory: Transdermal Patches (TDS) Area: System Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement The Explosion-Proof HVAC System has…

Checkweigher (Inline) – Qualification Certificate Template

Qualification Certificate Equipment: Checkweigher (Inline) Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Packaging/Primary Equipment Identifier: [Equipment Identifier] Protocol References: [Protocol References] Execution Dates: [Execution Dates] Qualification Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance…

Microencapsulation Reactor / Vessel – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment Name: Microencapsulation Reactor / Vessel Subcategory: NDDS – Microspheres & Microcapsules Area: R&D/Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifiers: [Insert Equipment ID] Protocol References: [Insert Protocol Ref]…

Coding Machine (Inkjet/Laser) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Coding Machine (Inkjet/Laser) Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: Packaging Qualification Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification (PQ): Yes Qualification Details Equipment Identifier:…