Tag: QUALIFICATION-CERTIFICATE

Serialization System – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment: Serialization System Subcategory: Suppositories & Implants Area: Packaging Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Protocol References Protocol Reference: [Insert Protocol Reference] Execution Dates Execution Date: [Insert Execution Date] Calibration Status…

Lyophilizer Stoppering System – Qualification Certificate Template

Qualification Certificate Equipment: Lyophilizer Stoppering System Subcategory: Sterile Powders & Lyophilized Products 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 The Lyophilizer Stoppering…

VHP Decontamination Unit (if isolator/RABS) – Qualification Certificate Template

Qualification Certificate Equipment: VHP Decontamination Unit Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) 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 The VHP…

VHP Generator / Decontamination Unit – Qualification Certificate Template

Qualification Certificate Equipment: VHP Generator / Decontamination Unit Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall…

Crimping Machine (Pump Fixing) – Qualification Certificate Template

Qualification Certificate Equipment: Crimping Machine (Pump Fixing) Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement…

Sterile Hold Tank (Pressurized) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment Name: Sterile Hold Tank (Pressurized) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Dates:…

Desiccant Inserter (if required) – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment: Desiccant Inserter Subcategory: Transdermal Patches (TDS) Area: Packaging Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Date: [Execution Date] Calibration Status: [Calibration…

Lyophilizer Shelf Temperature Control – Qualification Certificate Template

Qualification Certificate Equipment: Lyophilizer Shelf Temperature Control Subcategory: Sterile Powders & Lyophilized Products Area: Production Equipment Identifier: [Equipment Identifier] DQ/IQ/OQ/PQ: Yes / Yes / Yes / Yes Requalification Frequency: 12 Months Protocol References: [Protocol Reference 1], [Protocol Reference 2] Execution…

Nitrogen Purging System – Qualification Certificate Template

Qualification Certificate Equipment: Nitrogen Purging System Subcategory: Prefilled Syringes & Cartridges Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement [Overall Qualification Statement] Approvals…