Author: Auditor

SOP for Handling of Import and Export Documentation

SOP for Handling of Import and Export Documentation Handling of Import and Export Documentation – Standard Operating Procedure 1) Purpose To establish a standardized process for handling import and export documentation to ensure compliance with regulatory requirements, facilitate smooth customs clearance, and maintain accurate records within the pharmaceutical purchase department. 2) Scope This SOP applies…

Purchase Departments

SOP for Supplier Qualification for Raw Materials in Gels Production

SOP for Supplier Qualification for Raw Materials in Gels Production Standard Operating Procedure for Supplier Qualification for Raw Materials in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the qualification and approval of suppliers providing raw materials used in the manufacturing of gels to ensure consistent quality and compliance…

Gels

SOP for Maintenance of Incubators and Ovens

SOP for Maintenance of Incubators and Ovens Standard Operating Procedure for Maintenance of Incubators and Ovens 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of incubators and ovens to ensure consistent performance and reliability in maintaining temperature and humidity conditions for pharmaceutical processes. 2) Scope This SOP…

Maintenance Dept.

SOP for Equipment Qualification in Gels Production

SOP for Equipment Qualification in Gels Production Standard Operating Procedure for Equipment Qualification in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the qualification of equipment used in the manufacturing of gels to ensure that equipment is suitable for its intended use and capable of producing quality products. 2)…

Gels

SOP for Pest Control in Gels Production Area

SOP for Pest Control in Gels Production Area Standard Operating Procedure for Pest Control in Gels Production Area 1) Purpose The purpose of this SOP is to establish procedures for preventing, monitoring, and controlling pests within the gels production area to ensure compliance with regulatory requirements and maintain a hygienic environment. 2) Scope This SOP…

Gels

SOP for HVAC System Maintenance in Gels Production

SOP for HVAC System Maintenance in Gels Production Standard Operating Procedure for HVAC System Maintenance in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the maintenance and operation of HVAC (Heating, Ventilation, and Air Conditioning) systems within the gels production area to maintain controlled environmental conditions and ensure product…

Gels

SOP for Reference Standard Management

SOP for Reference Standard Management Standard Operating Procedure for Reference Standard Management 1) Purpose This SOP outlines the procedures for the handling, storage, qualification, use, and disposal of reference standards to ensure their integrity, traceability, and compliance with regulatory requirements in pharmaceutical testing and analysis. 2) Scope This SOP applies to all laboratory personnel involved…

Quality Assurance

SOP for Environmental Monitoring in the Manufacturing Area

SOP for Environmental Monitoring in the Manufacturing Area Standard Operating Procedure for Environmental Monitoring in the Manufacturing Area 1) Purpose The purpose of this SOP is to establish procedures for monitoring and controlling the environmental conditions within the pharmaceutical manufacturing area to ensure compliance with regulatory requirements and maintain product quality. 2) Scope This SOP…

Injectables

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 establish procedures for measuring and evaluating the particle size distribution of gels to ensure consistency and quality control during manufacturing. 2) Scope This SOP applies to all personnel involved in…

Gels

SOP for Maintenance of Refrigeration Units

SOP for Maintenance of Refrigeration Units Standard Operating Procedure for Maintenance of Refrigeration Units 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of refrigeration units to ensure optimal performance and reliability in storing pharmaceutical products. 2) Scope This SOP applies to all refrigeration units used in pharmaceutical…

Maintenance Dept.