Tag: QUALIFICATION-CERTIFICATE

SIP System (Tanks/Lines) – Qualification Certificate Template

Qualification Certificate Equipment: SIP System (Tanks/Lines) Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production/Sterilization Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Frequency Frequency: 12 Months Equipment Identifiers Equipment ID: [Equipment ID Placeholder] Serial Number: [Serial Number…

Aseptic Filling (PFS/Vials) for LAI – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Aseptic Filling (PFS/Vials) for LAI Subcategory: NDDS – Long-Acting Injectables (Depot Suspensions) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Insert Identifier] Protocol Reference: [Insert Protocol Reference]…

VHP Generator – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: VHP Generator Subcategory: Prefilled Syringes & Cartridges Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Information Requalification Frequency: 12 Months Qualification Details Equipment Identifier: [Insert Equipment Identifier] Protocol Reference: [Insert…

Inline Particle Size Analyzer (PAT – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Inline Particle Size Analyzer (PAT) Subcategory: NDDS – Long-Acting Injectables (Depot Suspensions) Area: Instrument Qualification Flags DQ: Critical/Yes IQ: Yes OQ: Yes PQ: Yes Requalification Information Requalification Frequency: Yes Protocol References Protocol Reference: [Insert Protocol…

Lyophilizer SCADA / Control System – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Lyophilizer SCADA / Control System Subcategory: Sterile Powders & Lyophilized Products Area: System Qualification Flags DQ: Critical / Yes IQ: Yes OQ: Yes PQ: Yes Requalification Information Requalification Frequency: Yes Protocol References Protocol Reference: [Insert…

Isolator / RABS System – Qualification Certificate Template

Qualification Certificate Equipment: Isolator / RABS System Subcategory: Prefilled Syringes & Cartridges Area: Production Equipment Identifier [Equipment Identifier] Protocol References [Protocol References] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement The Isolator /…

Depot Suspension Preparation Vessel – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Depot Suspension Preparation Vessel Subcategory: NDDS – Long-Acting Injectables (Depot Suspensions) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Insert Equipment Identifier] Protocol Reference: [Insert Protocol Reference]…

CIP Skid – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: CIP Skid Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: Production/Cleaning Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol References: [Protocol References] Execution Dates: [Execution…

Leak Test Machine (Bag – Pressure/Vacuum) – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment: Leak Test Machine (Bag – Pressure/Vacuum) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production/QC Qualification Status DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Frequency: 12 Months Execution Details Equipment Identifier: [Equipment Identifier] Protocol…

SIP System – Qualification Certificate Template

Qualification Certificate Equipment: SIP System Subcategory: Prefilled Syringes & Cartridges Area: Production DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Frequency: 12 Months Next Due Date: [Next Due Date Placeholder] Protocol References: [Protocol References Placeholder] Execution Dates: [Execution Dates…