Tag: QUALIFICATION-CERTIFICATE

Colloid Mill (if used) – Qualification Certificate Template

Qualification Certificate Equipment: Colloid Mill Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) 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…

Bottle Washing / Rinsing Machine – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment Name: Bottle Washing / Rinsing Machine Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Schedule Requalification Frequency: 12 Months Next Due Date: [Next Due…

Suppository Molding Machine – Qualification Certificate Template

Qualification Certificate Equipment: Suppository Molding Machine Subcategory: Suppositories & Implants Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification Statement [Overall Qualification Statement] Approvals…

Distillation Unit / Distillation Column – Qualification Certificate Template

Qualification Certificate Equipment: Distillation Unit / Distillation Column Subcategory: API Manufacturing (Chemical Synthesis & Purification) Area: Production Equipment Identifier: [Equipment Identifier] Protocol References: [Protocol Reference] Execution Dates: [Execution Date] Calibration Status: [Calibration Status] Deviations Summary: [Deviations Summary] Qualification Flags DQ:…

Inline Sterile Filtration Skid – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Inline Sterile Filtration Skid Subcategory: Sterile Powders & Lyophilized Products Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Date: [Execution…

Sterile Filtration Skid – Qualification Certificate Template

Qualification Certificate Equipment: Sterile Filtration Skid Subcategory: Prefilled Syringes & Cartridges 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 Qualification Statement]…

Ophthalmic Sterile Filtration Skid (0.22 µm) – Qualification Certificate Template

Qualification Certificate Equipment: Ophthalmic Sterile Filtration Skid (0.22 µm) Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production Qualification Type Status Design Qualification (DQ) Yes Installation Qualification (IQ) Yes Operational Qualification (OQ) Yes Performance Qualification (PQ) Yes Qualification Details Equipment Identifiers:…

Microfluidic Mixer (LNP/Liposome Formation) – Qualification Certificate Template

Qualification Certificate Equipment: Microfluidic Mixer (LNP/Liposome Formation) Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: R&D/Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol References: [Protocol References] Execution Dates: [Execution…

Bottle Blow Molding Machine – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Bottle Blow Molding Machine Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Qualification Status DQ Status: Yes IQ Status: Yes OQ Status: Yes PQ Status: Yes Qualification Details Equipment Identifier: [Insert Equipment Identifier] Protocol Reference:…

Vacuum Degassing System – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Vacuum Degassing System Subcategory: Suppositories & Implants Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Dates: [Execution Dates] Calibration Status:…