Author: Auditor

Injectables: SOP for Cleaning Validation in Manufacturing Area

SOP for Cleaning Validation in Manufacturing Area Standard Operating Procedure for Cleaning Validation in Manufacturing Area 1) Purpose The purpose of this SOP is to outline the procedures for validating cleaning processes in the pharmaceutical manufacturing area to ensure removal of residues and contaminants from equipment and facilities. 2) Scope This SOP applies to all…

Injectables

SOP for Maintenance of Autoclaves

SOP for Maintenance of Autoclaves Standard Operating Procedure for Maintenance of Autoclaves 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of autoclaves to ensure proper sterilization and operational reliability in the pharmaceutical manufacturing process. 2) Scope This SOP applies to all autoclaves used in pharmaceutical manufacturing and…

Maintenance Dept.

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…

Gels

SOP for Warehouse Management for Gels Production

SOP for Warehouse Management for Gels Production Standard Operating Procedure for Warehouse Management for Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the efficient and controlled management of materials and finished products within the warehouse dedicated to gels production, ensuring compliance with regulatory requirements and maintaining inventory integrity. 2)…

Gels

SOP for Retained Sample Management

SOP for Retained Sample Management Standard Operating Procedure for Retained Sample Management 1) Purpose This SOP outlines the procedures for the handling, storage, retention, and disposal of retained samples to ensure traceability, integrity, and compliance with regulatory requirements in pharmaceutical manufacturing. 2) Scope This SOP applies to all personnel involved in the collection, labeling, storage,…

Quality Assurance

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