SOP for Environmental Monitoring Standard Operating Procedure for Environmental Monitoring 1) Purpose The purpose of this SOP is to establish procedures for monitoring the environmental conditions of the manufacturing areas to ensure they meet the required standards for the production of injection products. 2) Scope This SOP applies to all personnel involved in environmental monitoring…
Bioburden testing for injections
SOP for Gowning and Degowning Procedures
SOP for Gowning and Degowning Procedures Standard Operating Procedure for Gowning and Degowning Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for gowning and degowning to ensure that manufacturing personnel maintain a controlled and contaminant-free environment during the production of injection products. 2) Scope This SOP applies to all personnel…
SOP for Personal Hygiene for Manufacturing Staff
SOP for Personal Hygiene for Manufacturing Staff Standard Operating Procedure for Personal Hygiene for Manufacturing Staff 1) Purpose The purpose of this SOP is to define the personal hygiene requirements for manufacturing staff to prevent contamination and ensure a hygienic environment for the production of injection products. 2) Scope This SOP applies to all manufacturing…
SOP for Cleaning and Sanitization of Manufacturing Area
SOP for Cleaning and Sanitization of Manufacturing Area Standard Operating Procedure for Cleaning and Sanitization of Manufacturing Area 1) Purpose The purpose of this SOP is to establish the procedures for cleaning and sanitizing the manufacturing area to prevent contamination and maintain a controlled environment for the production of injection products. 2) Scope This SOP…
SOP for WFI Storage and Distribution
SOP for WFI Storage and Distribution Standard Operating Procedure for WFI Storage and Distribution 1) Purpose The purpose of this SOP is to outline the procedures for the storage and distribution of Water for Injection (WFI) to ensure its quality is maintained until use in the manufacturing of injection products. 2) Scope This SOP applies…
Injectables: SOP for Water for Injection (WFI) Generation
SOP for Water for Injection (WFI) Generation Standard Operating Procedure for Water for Injection (WFI) Generation 1) Purpose The purpose of this SOP is to outline the procedures for the generation of Water for Injection (WFI) to ensure its quality and compliance with regulatory standards for use in the manufacturing of injection products. 2) Scope…
Injectables: SOP for Raw Material Testing and Approval
SOP for Raw Material Testing and Approval Standard Operating Procedure for Raw Material Testing and Approval 1) Purpose The purpose of this SOP is to establish the procedure for the testing and approval of raw materials to ensure they meet the required quality standards before being used in the manufacturing process. 2) Scope This SOP…
Injectables: SOP for Raw Material Storage
SOP for Raw Material Storage Standard Operating Procedure for Raw Material Storage 1) Purpose The purpose of this SOP is to define the procedures for the proper storage of raw materials to ensure their quality and integrity are maintained until they are used in the manufacturing process. 2) Scope This SOP applies to all raw…
Injectables: SOP for Raw Material Procurement
SOP for Raw Material Procurement Standard Operating Procedure for Raw Material Procurement 1) Purpose The purpose of this SOP is to establish a standardized procedure for the procurement of raw materials required for the manufacturing of intramuscular, subcutaneous, and intravenous injection products, ensuring compliance with regulatory standards and maintaining product quality. 2) Scope This SOP…