Author: Auditor

Injectables: SOP for Sterilization Procedures for Manufacturing Equipment

SOP for Sterilization Procedures for Manufacturing Equipment Standard Operating Procedure for Sterilization Procedures for Manufacturing Equipment 1) Purpose The purpose of this SOP is to outline the procedures for sterilizing manufacturing equipment used in pharmaceutical production to ensure the elimination of microbial contaminants and maintain product quality and safety. 2) Scope This SOP applies to…

Injectables

SOP for Label Inspection for Gels

SOP for Label Inspection for Gels Standard Operating Procedure for Label Inspection for Gels 1) Purpose The purpose of this SOP is to define procedures for inspecting labels used on gels to ensure accuracy, completeness, and compliance with regulatory requirements. 2) Scope This SOP applies to the Quality Assurance (QA) and Packaging departments responsible for…

Gels

SOP for Packaging Line Qualification for Gels

SOP for Packaging Line Qualification for Gels Standard Operating Procedure for Packaging Line Qualification for Gels 1) Purpose The purpose of this SOP is to establish procedures for the qualification of the packaging line used for gels to ensure that packaging processes meet specified requirements and produce quality products. 2) Scope This SOP applies to…

Gels

SOP for Regulatory Inspection Readiness

SOP for Regulatory Inspection Readiness Standard Operating Procedure for Regulatory Inspection Readiness 1) Purpose This SOP outlines the procedures for ensuring that the organization is prepared for and can effectively manage regulatory inspections by health authorities. 2) Scope This SOP applies to all personnel within the organization who may be involved in or affected by…

Quality Assurance

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