Tag: SOP pharmaceutical industry

SOP for Formulation Development Process Validation

SOP for Formulation Development Process Validation Validation of Manufacturing Processes in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for process validation in formulation development, ensuring that manufacturing processes consistently produce pharmaceutical products of desired quality attributes and meet regulatory requirements. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Maintenance of Coating Machines

SOP for Maintenance of Coating Machines Standard Operating Procedure for Maintenance of Coating Machines 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of coating machines in pharmaceutical manufacturing facilities to ensure efficient coating processes and product quality. 2) Scope This SOP applies to all coating machines used…

Maintenance Dept.

SOP for Formulation Development Raw Material Specification Development

SOP for Formulation Development Raw Material Specification Development Development of Raw Material Specifications in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for developing raw material specifications in formulation development, ensuring that raw materials used in pharmaceutical formulations meet predefined quality standards and regulatory requirements. 2) Scope This SOP…

Formulation Development

SOP for Formulation Development Equipment Qualification

SOP for Formulation Development Equipment Qualification Qualification of Equipment in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for equipment qualification in formulation development, ensuring that equipment used in manufacturing processes is suitable for its intended purpose and meets regulatory requirements. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Maintenance of Capsule Filling Machines

SOP for Maintenance of Capsule Filling Machines Standard Operating Procedure for Maintenance of Capsule Filling Machines 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of capsule filling machines in pharmaceutical manufacturing facilities to ensure efficient capsule filling processes and product quality. 2) Scope This SOP applies to…

Maintenance Dept.

SOP for Formulation Development Cleaning Validation

SOP for Formulation Development Cleaning Validation Validation of Cleaning Procedures in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for validating cleaning procedures in formulation development, ensuring that equipment and facilities are cleaned effectively to prevent cross-contamination and ensure product quality. 2) Scope This SOP applies to all formulation…

Formulation Development

SOP for Formulation Development Quality by Design (QbD) Principles

SOP for Formulation Development Quality by Design (QbD) Principles Implementing Quality by Design (QbD) Principles in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for implementing Quality by Design (QbD) principles during the formulation development process, ensuring that product quality is built into the formulation design based on scientific…

Formulation Development

SOP for Maintenance of Tablet Presses

SOP for Maintenance of Tablet Presses Standard Operating Procedure for Maintenance of Tablet Presses 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of tablet presses in pharmaceutical manufacturing facilities to ensure efficient tablet production and product quality. 2) Scope This SOP applies to all tablet presses used…

Maintenance Dept.

SOP for Formulation Development Risk Management Plan

SOP for Formulation Development Risk Management Plan Formulating a Risk Management Plan in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for developing a risk management plan during the formulation development process, ensuring that potential risks are identified, assessed, and managed to enhance product quality and safety. 2) Scope…

Formulation Development

SOP for Maintenance of Granulators

SOP for Maintenance of Granulators Standard Operating Procedure for Maintenance of Granulators 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of granulators in pharmaceutical manufacturing facilities to ensure efficient granulation processes and product quality. 2) Scope This SOP applies to all granulators used within the facility premises….

Maintenance Dept.