Author: Auditor

SOP for Maintenance of Material Handling Equipment

SOP for Maintenance of Material Handling Equipment Standard Operating Procedure for Maintenance of Material Handling Equipment 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of material handling equipment to ensure safe and efficient movement of materials within pharmaceutical manufacturing facilities. 2) Scope This SOP applies to all…

Maintenance Dept.

SOP for Process Simulation Testing in Gels Production

SOP for Process Simulation Testing in Gels Production Standard Operating Procedure for Process Simulation Testing in Gels Production 1) Purpose The purpose of this SOP is to define procedures for conducting process simulation testing in gels production to ensure the reproducibility and consistency of manufacturing processes. 2) Scope This SOP applies to the Production and…

Gels

SOP for Validation of Analytical Methods for Gels

SOP for Validation of Analytical Methods for Gels Standard Operating Procedure for Validation of Analytical Methods for Gels 1) Purpose The purpose of this SOP is to establish procedures for the validation of analytical methods used for testing gels to ensure accurate and reliable analytical results. 2) Scope This SOP applies to the Quality Control…

Gels

SOP for Validation of Cleaning Procedures in Gels Production

SOP for Validation of Cleaning Procedures in Gels Production Standard Operating Procedure for Validation of Cleaning Procedures in Gels Production 1) Purpose The purpose of this SOP is to define procedures for validating cleaning processes in gels production to ensure equipment is effectively cleaned and maintained. 2) Scope This SOP applies to the Quality Assurance…

Gels

SOP for Regulatory Submission and Filing

SOP for Regulatory Submission and Filing Standard Operating Procedure for Regulatory Submission and Filing 1) Purpose This SOP outlines the procedures for preparing, submitting, and filing regulatory documents to regulatory authorities for approval of pharmaceutical products. 2) Scope This SOP applies to all personnel involved in regulatory affairs, including regulatory affairs managers, regulatory affairs specialists,…

Quality Assurance

SOP for Endotoxin Testing in Aseptic Gels

SOP for Endotoxin Testing in Aseptic Gels Standard Operating Procedure for Endotoxin Testing in Aseptic Gels 1) Purpose The purpose of this SOP is to establish procedures for detecting and quantifying endotoxin levels in aseptic gels to ensure product safety and compliance. 2) Scope This SOP applies to the Quality Control (QC) department responsible for…

Gels

SOP for Maintenance of Lifts and Elevators

SOP for Maintenance of Lifts and Elevators Standard Operating Procedure for Maintenance of Lifts and Elevators 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of lifts and elevators to ensure safe and reliable vertical transportation within pharmaceutical manufacturing facilities. 2) Scope This SOP applies to all lifts…

Maintenance Dept.

SOP for Sterility Testing in Aseptic Gels

SOP for Sterility Testing in Aseptic Gels Standard Operating Procedure for Sterility Testing in Aseptic Gels 1) Purpose The purpose of this SOP is to define procedures for conducting sterility testing on aseptic gels to ensure they are free from viable microorganisms. 2) Scope This SOP applies to the Quality Control (QC) department responsible for…

Gels

Injectables: SOP for Gowning Procedures in Cleanroom Environment

SOP for Gowning Procedures in Cleanroom Environment Standard Operating Procedure for Gowning Procedures in Cleanroom Environment 1) Purpose The purpose of this SOP is to define the procedures for gowning in a cleanroom environment to prevent contamination of pharmaceutical products and ensure compliance with cleanliness standards. 2) Scope This SOP applies to all personnel entering…

Injectables

SOP for Foreign Particulate Matter Testing in Gels

SOP for Foreign Particulate Matter Testing in Gels Standard Operating Procedure for Foreign Particulate Matter Testing in Gels 1) Purpose The purpose of this SOP is to establish procedures for detecting and quantifying foreign particulate matter in gels to ensure product safety and quality. 2) Scope This SOP applies to the Quality Control (QC) department…

Gels