Tag: Equipment Qualification SOP

SOP for Formulation Development Post-Approval Changes

SOP for Formulation Development Post-Approval Changes Post-Approval Changes in Formulation Development 1) Purpose The purpose of this SOP is to establish procedures for managing post-approval changes in formulation development, ensuring that changes to approved drug products are evaluated, implemented, and documented in accordance with regulatory requirements and good manufacturing practices (GMP). 2) Scope This SOP…

Formulation Development

SOP for Formulation Development Quality Risk Assessment

SOP for Formulation Development Quality Risk Assessment Quality Risk Assessment in Formulation Development 1) Purpose The purpose of this SOP is to outline procedures for conducting quality risk assessments (QRAs) in formulation development, identifying potential risks associated with product quality, safety, and efficacy, and implementing risk mitigation strategies to ensure compliance with regulatory requirements. 2)…

Formulation Development

SOP for Formulation Development Stability Trend Analysis

SOP for Formulation Development Stability Trend Analysis Stability Trend Analysis in Formulation Development 1) Purpose The purpose of this SOP is to establish procedures for conducting stability trend analysis in formulation development, monitoring the stability of drug products over time, identifying degradation trends, and ensuring product quality and safety. 2) Scope This SOP applies to…

Formulation Development

SOP for Formulation Development Clinical Trial Material Manufacturing

SOP for Formulation Development Clinical Trial Material Manufacturing Clinical Trial Material Manufacturing in Formulation Development 1) Purpose The purpose of this SOP is to establish procedures for the manufacturing of clinical trial materials (CTMs) in formulation development, ensuring adherence to Good Manufacturing Practices (GMP), compliance with regulatory requirements, and facilitation of clinical trials. 2) Scope…

Formulation Development

SOP for Formulation Development Market Analysis

SOP for Formulation Development Market Analysis Market Analysis in Formulation Development 1) Purpose The purpose of this SOP is to outline procedures for conducting comprehensive market analysis in formulation development, facilitating informed decision-making, identifying market opportunities, and supporting strategic planning and product development. 2) Scope This SOP applies to the market analysis activities conducted within…

Formulation Development

SOP for Formulation Development Vendor Management

SOP for Formulation Development Vendor Management Vendor Management in Formulation Development 1) Purpose The purpose of this SOP is to establish procedures for effectively managing vendor relationships and ensuring the delivery of high-quality materials, equipment, and services essential to formulation development activities, thereby supporting operational efficiency and compliance with regulatory requirements. 2) Scope This SOP…

Formulation Development

SOP for Formulation Development Supplier Qualification

SOP for Formulation Development Supplier Qualification Supplier Qualification in Formulation Development 1) Purpose The purpose of this SOP is to establish procedures for the qualification and evaluation of suppliers involved in providing raw materials, excipients, equipment, and services critical to formulation development activities, ensuring consistent quality, reliability, and compliance with regulatory requirements. 2) Scope This…

Formulation Development

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 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