The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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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SOP for Conducting Internal Audits in Aerosol Production Standard Operating Procedure for Conducting Internal Audits in Aerosol Production 1) Purpose The purpose of this SOP is to establish a standardized procedure for conducting internal audits in aerosol production to ensure compliance with regulatory requirements, company policies, and quality standards. Internal audits help identify areas for…
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SOP for Change Control in Manufacturing Processes Standard Operating Procedure for Change Control in Manufacturing Processes 1) Purpose The purpose of this SOP is to establish procedures for initiating, evaluating, implementing, and documenting changes to manufacturing processes to maintain product quality, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel…
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SOP for Analytical Method Development Chromatographic Method Development Developing Chromatographic Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing chromatographic methods during the analytical method development process, ensuring accurate separation and quantification of analytes in pharmaceutical formulations. 2) Scope This SOP applies to all personnel…
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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 Pharmacovigilance Case Assessment Guidelines for Assessing Pharmacovigilance Cases 1) Purpose The purpose of this SOP is to establish procedures for the assessment of pharmacovigilance cases to ensure accurate evaluation of adverse event reports and other safety information. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the assessment of case reports,…
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 Annual Product Review in Aerosol Production Standard Operating Procedure for Annual Product Review in Aerosol Production 1) Purpose The purpose of this SOP is to outline the procedures for conducting an annual product review (APR) for aerosol products. The APR is designed to ensure that the product consistently meets quality specifications and regulatory…
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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…
SOP for Analytical Method Development Particle Size Method Development Developing Particle Size Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing particle size methods during the analytical method development process, ensuring accurate measurement of particle size distribution in pharmaceutical formulations. 2) Scope This SOP applies…
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