Tag: SOP for Validations

SOP for Qualification of Depyrogenation Tunnels

SOP for Qualification of Depyrogenation Tunnels Standard Operating Procedure for Qualification of Depyrogenation Tunnels 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying depyrogenation tunnels used in pharmaceutical manufacturing. This SOP ensures that the depyrogenation tunnels are correctly installed, calibrated, and operate in compliance with the required…

Validations and Qualifications

SOP for Qualification of RABS (Restricted Access Barrier Systems)

SOP for Qualification of RABS (Restricted Access Barrier Systems) Standard Operating Procedure for Qualification of RABS (Restricted Access Barrier Systems) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying Restricted Access Barrier Systems (RABS) used in pharmaceutical manufacturing areas, particularly for aseptic processing. This SOP ensures that…

Validations and Qualifications

SOP for Qualification of HVAC Systems for Sterile Areas

SOP for Qualification of HVAC Systems for Sterile Areas Standard Operating Procedure for Qualification of HVAC Systems for Sterile Areas 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying Heating, Ventilation, and Air Conditioning (HVAC) systems used in sterile areas within pharmaceutical manufacturing environments. This SOP ensures…

Validations and Qualifications

SOP for Qualification of Laminar Air Flow Units

SOP for Qualification of Laminar Air Flow Units Standard Operating Procedure for Qualification of Laminar Air Flow Units 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying laminar air flow (LAF) units used in pharmaceutical manufacturing areas to maintain the required clean air standards. This SOP ensures…

Validations and Qualifications

SOP for IQ/OQ/PQ of Cryogenic Storage Systems

SOP for IQ/OQ/PQ of Cryogenic Storage Systems Standard Operating Procedure for IQ/OQ/PQ of Cryogenic Storage Systems 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of cryogenic storage systems used in pharmaceutical manufacturing. This SOP ensures that…

Validations and Qualifications

SOP for Qualification of Freeze-Drying Chambers

SOP for Qualification of Freeze-Drying Chambers Standard Operating Procedure for Qualification of Freeze-Drying Chambers 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying freeze-drying chambers used in the pharmaceutical manufacturing of injectable products, vaccines, and biologics. This SOP ensures that the freeze-drying chambers are correctly installed, calibrated,…

Validations and Qualifications

SOP for Qualification of Filling Machines for Inhalers

SOP for Qualification of Filling Machines for Inhalers Standard Operating Procedure for Qualification of Filling Machines for Inhalers 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying filling machines used for the filling of inhaler products in pharmaceutical manufacturing. This SOP ensures that the filling machines are…

Validations and Qualifications

SOP for Qualification of Isolators in Aseptic Areas

SOP for Qualification of Isolators in Aseptic Areas Standard Operating Procedure for Qualification of Isolators in Aseptic Areas 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying isolators used in aseptic areas within pharmaceutical manufacturing. This SOP ensures that the isolators are properly installed, calibrated, and operate…

Validations and Qualifications

SOP for Qualification of Lyophilizers for Injectable Products

SOP for Qualification of Lyophilizers for Injectable Products Standard Operating Procedure for Qualification of Lyophilizers for Injectable Products 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying lyophilizers (freeze dryers) used in pharmaceutical manufacturing for the production of injectable products. This SOP ensures that the lyophilizer is…

Validations and Qualifications

SOP for Qualification of Sterilizers (Autoclaves)

SOP for Qualification of Sterilizers (Autoclaves) Standard Operating Procedure for Qualification of Sterilizers (Autoclaves) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying sterilizers (autoclaves) used in pharmaceutical manufacturing for sterilizing equipment, containers, and materials. This SOP ensures that the sterilizers are correctly installed, calibrated, and operate…

Validations and Qualifications