The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Change Control in Aerosol Production Standard Operating Procedure for Change Control in Aerosol Production 1) Purpose The purpose of this SOP is to establish a controlled and documented process for managing changes in aerosol production. This ensures that all changes are evaluated, approved, and implemented in a way that maintains product quality and…
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 Analytical Method Development Titration Method Development Developing Titration Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing titration methods during the analytical method development process, ensuring accurate determination of analyte concentration using titrimetric techniques. 2) Scope This SOP applies to all personnel involved…
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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…
SOP for Cleaning Validation in Aerosol Production Standard Operating Procedure for Cleaning Validation in Aerosol Production 1) Purpose The purpose of this SOP is to outline the procedures for performing cleaning validation in aerosol production. Cleaning validation ensures that the cleaning processes consistently remove residues to predetermined levels of acceptability to prevent contamination and cross-contamination….
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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 Pharmacovigilance Case Narrative Writing Guidelines for Writing Pharmacovigilance Case Narratives 1) Purpose The purpose of this SOP is to establish standardized procedures for writing case narratives in pharmacovigilance to ensure clear, concise, and accurate documentation of adverse event reports. 2) Scope This SOP applies to all pharmacovigilance personnel involved in writing case narratives,…
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SOP for Analytical Method Development Spectroscopic Method Development Developing Spectroscopic Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing spectroscopic methods during the analytical method development process, ensuring accurate measurement of analytes using spectroscopic techniques. 2) Scope This SOP applies to all personnel involved in…
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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 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…
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