Tag: QUALIFICATION-CERTIFICATE

Parts Washer – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Parts Washer Subcategory: Transdermal Patches (TDS) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Information Requalification Frequency: 24 Months Execution Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution…

Coding Machine – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment: Coding Machine Subcategory: Sterile Powders & Lyophilized Products Area: Packaging Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Requalification Frequency: 12 Months Equipment Identifier: [Insert Equipment Identifier] Protocol Reference: [Insert Protocol…

Coding Machine (Laser / Inkjet) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Coding Machine (Laser / Inkjet) Subcategory: Prefilled Syringes & Cartridges Area: Packaging Qualification Details DQ Flag: Yes IQ Flag: Yes OQ Flag: Yes PQ Flag: Yes Execution Dates DQ Execution Date: [Insert DQ Execution Date]…

Automated Visual Inspection (AVI) Machine – Qualification Certificate Template

Qualification Certificate Equipment: Automated Visual Inspection (AVI) Machine Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production Equipment Identifier [Equipment Identifier] Protocol References [Protocol References] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification Statement…

Spray Dryer (Nano/Micro particles) – Qualification Certificate Template

Qualification Certificate Equipment: Spray Dryer (Nano/Micro particles) Subcategory: NDDS – Polymeric Nanoparticles (PLGA etc.) Area: R&D/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…

Port/Outlet Welding Station (Bag Line) – Qualification Certificate Template

Qualification Certificate Equipment: Port/Outlet Welding Station (Bag Line) 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 References: [Protocol Reference] Execution Dates: [Execution Date]…

Implant Sterilization System (EO/Gamma/Autoclave) – Qualification Certificate Template

Qualification Certificate Equipment: Implant Sterilization System (EO/Gamma/Autoclave) Subcategory: Implants (Drug-Eluting / Biodegradable) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifiers: [Insert Equipment Identifiers] Protocol References: [Insert Protocol References] Execution Dates: [Insert Execution…

CIP System – Qualification Certificate Template

Qualification Certificate Equipment: CIP System Subcategory: Transdermal Patches (TDS) 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 The CIP System has been qualified…

CCIT System (Vacuum Decay/Helium/HVLD) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: CCIT System (Vacuum Decay/Helium/HVLD) Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: QC/Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Information Requalification Frequency: 12 Months Equipment Identifiers Serial Number: [Insert Serial Number]…

Ultracentrifuge – Qualification Certificate Template

Qualification Certificate Equipment: Ultracentrifuge Subcategory: NDDS – Polymeric Nanoparticles (PLGA etc.) Area: R&D/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 Ultracentrifuge has…