Author: Auditor

Quality Assurance: SOP for Out of Specification (OOS) Handling in Gels Production

SOP for Out of Specification (OOS) Handling in Gels Production Standard Operating Procedure for Out of Specification (OOS) Handling in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the identification, investigation, and handling of Out of Specification (OOS) results encountered during gels production, ensuring accurate data interpretation, product quality…

Quality Assurance

SOP for Calibration of Conductivity Meters

SOP for Calibration of Conductivity Meters Standard Operating Procedure for Calibration of Conductivity Meters 1) Purpose The purpose of this SOP is to establish the procedures for calibrating conductivity meters to ensure accuracy and reliability in conductivity measurements as per regulatory requirements in the pharmaceutical industry. 2) Scope This SOP applies to all conductivity meters…

Maintenance Dept.

SOP for IT Systems Used in Procurement

SOP for IT Systems Used in Procurement IT Systems Used in Procurement – Standard Operating Procedure 1) Purpose To establish a standardized process for the utilization, management, and maintenance of IT systems used in the procurement process to ensure efficiency, data accuracy, and compliance within the pharmaceutical purchase department. 2) Scope This SOP applies to…

Purchase Departments

Quality Assurance: SOP for Deviation Handling in Gels Production

SOP for Deviation Handling in Gels Production Standard Operating Procedure for Deviation Handling in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations that occur during gels production, ensuring product quality, process integrity, and compliance with regulatory requirements. 2) Scope This SOP…

Quality Assurance

SOP for Data Integrity Assurance

SOP for Data Integrity Assurance Standard Operating Procedure for Data Integrity Assurance 1) Purpose This SOP outlines the procedures to ensure data integrity in pharmaceutical manufacturing and documentation practices to comply with regulatory requirements and maintain accuracy, completeness, and reliability of data. 2) Scope This SOP applies to all personnel involved in generating, recording, reviewing,…

Quality Assurance

Quality Assurance: SOP for Process Validation Protocols for Gels

SOP for Process Validation Protocols for Gels Standard Operating Procedure for Process Validation Protocols for Gels 1) Purpose The purpose of this SOP is to define the procedures for conducting process validation protocols for gels production to ensure consistent product quality, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all stages…

Quality Assurance

Gels: SOP for Particle Size Distribution in Gels

SOP for Particle Size Distribution in Gels Standard Operating Procedure for Particle Size Distribution in Gels 1) Purpose The purpose of this SOP is to define procedures for determining the particle size distribution of particulate matter in gel products to ensure consistency and quality. 2) Scope This SOP applies to all personnel involved in particle…

Gels

Quality Assurance: SOP for Handling Hazardous Materials in Gels Production

SOP for Handling Hazardous Materials in Gels Production Standard Operating Procedure for Handling Hazardous Materials in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the safe handling, storage, and disposal of hazardous materials used in the manufacturing of gels, ensuring employee safety, environmental protection, and regulatory compliance. 2) Scope…

Quality Assurance

Quality Assurance: SOP for Inventory Control in Gels Production

SOP for Inventory Control in Gels Production Standard Operating Procedure for Inventory Control in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the systematic management and control of inventory related to raw materials, intermediates, and finished products within the gels production department, ensuring accuracy, traceability, and compliance with regulatory…

Quality Assurance

SOP for Assay of Active Ingredient in Gels

SOP for Assay of Active Ingredient in Gels Standard Operating Procedure for Assay of Active Ingredient in Gels 1) Purpose The purpose of this SOP is to establish procedures for the quantitative determination of the active ingredient content in gel products to ensure potency and consistency. 2) Scope This SOP applies to all personnel involved…

Gels