The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Maintenance of Tablet Presses Standard Operating Procedure for Maintenance of Tablet Presses 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of tablet presses in pharmaceutical manufacturing facilities to ensure efficient tablet production and product quality. 2) Scope This SOP applies to all tablet presses used…
SOP for Analytical Method Development Forced Degradation Studies Conducting Forced Degradation Studies for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for conducting forced degradation studies during the analytical method development process, aimed at evaluating method specificity and stability indicating capability. 2) Scope This SOP applies to all…
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SOP for Energy Control Procedures in Aerosol Production Standard Operating Procedure for Energy Control Procedures in Aerosol Production 1) Purpose The purpose of this SOP is to establish guidelines for controlling energy sources during aerosol production to ensure the safety of personnel and equipment. Proper energy control procedures prevent accidental startup or release of energy…
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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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SOP for Internal Audits of Manufacturing Processes Standard Operating Procedure for Internal Audits of Manufacturing Processes 1) Purpose The purpose of this SOP is to outline procedures for conducting internal audits of manufacturing processes to verify compliance with regulatory requirements, identify areas for improvement, and ensure consistent product quality. 2) Scope This SOP applies to…
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SOP for Maintenance of Granulators Standard Operating Procedure for Maintenance of Granulators 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of granulators in pharmaceutical manufacturing facilities to ensure efficient granulation processes and product quality. 2) Scope This SOP applies to all granulators used within the facility premises….
SOP for Analytical Method Development Stability Indicating Method Development Developing Stability Indicating Methods for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for developing stability indicating methods during the analytical method development process, ensuring methods capable of detecting and quantifying degradation products in stability studies. 2) Scope This…
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SOP for Formulation Development Deviation Handling Handling Deviations in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for handling deviations during the formulation development process, ensuring that deviations are documented, investigated, and resolved promptly to maintain product quality and compliance with regulatory requirements. 2) Scope This SOP applies to…
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SOP for Pharmacovigilance Database Management Guidelines for Managing Pharmacovigilance Databases 1) Purpose The purpose of this SOP is to define the procedures for managing pharmacovigilance databases to ensure data integrity, security, and accessibility for safety monitoring and reporting. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the management of safety databases, including…
SOP for Batch Reconciliation in Aerosol Production Standard Operating Procedure for Batch Reconciliation in Aerosol Production 1) Purpose The purpose of this SOP is to outline the procedures for batch reconciliation in aerosol production. Batch reconciliation ensures that all raw materials, intermediates, and finished products are accurately accounted for, thereby ensuring product quality and regulatory…
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