Tag: SOP pharmaceutical industry

SOP for Formulation Development Regulatory Strategy Development

SOP for Formulation Development Regulatory Strategy Development Regulatory Strategy Development in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedures for developing regulatory strategies in formulation development, ensuring compliance with regulatory requirements, facilitating product registration, and supporting successful regulatory submissions. 2) Scope This SOP applies to the planning, implementation, and…

Formulation Development

SOP for Formulation Development Design of Experiments (DoE)

SOP for Formulation Development Design of Experiments (DoE) Design of Experiments (DoE) in Formulation Development 1) Purpose The purpose of this SOP is to establish procedures for applying Design of Experiments (DoE) principles in formulation development, aiming to systematically optimize formulation processes, identify critical factors, and enhance product quality and efficiency. 2) Scope This SOP…

Formulation Development

SOP for Maintenance of Cartoning Machines

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

Maintenance Dept.

SOP for Formulation Development Comparative Evaluation Studies

SOP for Formulation Development Comparative Evaluation Studies Comparative Evaluation Studies in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting comparative evaluation studies in formulation development, aiming to assess and compare the performance, quality attributes, and characteristics of different formulations or processes to support decision-making and optimization. 2)…

Formulation Development

SOP for Formulation Development Technology Platform Assessment

SOP for Formulation Development Technology Platform Assessment Assessment of Technology Platforms in Formulation Development 1) Purpose The purpose of this SOP is to establish a procedure for the assessment and evaluation of technology platforms in formulation development, ensuring the selection of suitable platforms that align with project requirements, enhance efficiency, and support innovation. 2) Scope…

Formulation Development

SOP for Maintenance of Labeling Machines

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

Maintenance Dept.

SOP for Formulation Development Project Closure

SOP for Formulation Development Project Closure Project Closure in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for the systematic and efficient closure of formulation development projects, ensuring that all activities are completed, outcomes are evaluated, and documentation is finalized in accordance with organizational standards. 2) Scope This SOP…

Formulation Development

SOP for Formulation Development Intellectual Property Management

SOP for Formulation Development Intellectual Property Management Management of Intellectual Property in Formulation Development 1) Purpose The purpose of this SOP is to establish guidelines for the management and protection of intellectual property (IP) assets generated during formulation development activities, ensuring their proper identification, evaluation, protection, and utilization. 2) Scope This SOP applies to all…

Formulation Development

SOP for Maintenance of Filling and Sealing Machines

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

Maintenance Dept.

SOP for Formulation Development Continuous Improvement Initiatives

SOP for Formulation Development Continuous Improvement Initiatives Continuous Improvement Initiatives in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for implementing continuous improvement initiatives in formulation development, aiming to enhance efficiency, quality, and compliance of formulation processes and practices. 2) Scope This SOP applies to all formulation development activities…

Formulation Development