Tag: Regulatory submission SOP

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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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