The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Clinical Trial Material Production for Gels Standard Operating Procedure for Clinical Trial Material Production for Gels 1) Purpose The purpose of this SOP is to establish procedures for the production of clinical trial materials (CTMs) for gels used in clinical trials, ensuring that materials are manufactured, labeled, stored, and distributed in compliance with…
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SOP for Purchase Return Process Purchase Return Process – Standard Operating Procedure 1) Purpose To establish a standardized procedure for managing the return of purchased goods that are defective, damaged, or otherwise unacceptable, ensuring compliance with contractual agreements and regulatory requirements within the pharmaceutical purchase department. 2) Scope This SOP applies to all returns of…
SOP for Hazard Analysis and Critical Control Points (HACCP) Standard Operating Procedure for Hazard Analysis and Critical Control Points (HACCP) 1) Purpose This SOP outlines the procedures for implementing and maintaining a Hazard Analysis and Critical Control Points (HACCP) system to identify, evaluate, and control hazards related to food safety within the pharmaceutical manufacturing process….
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SOP for Scale-Up Processes in Gels Production Standard Operating Procedure for Scale-Up Processes in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the systematic scale-up of gels production processes from laboratory-scale to pilot-scale and commercial-scale production, ensuring consistency, quality, and compliance throughout the scale-up process. 2) Scope This SOP…
SOP for Technology Transfer in Gels Production Standard Operating Procedure for Technology Transfer in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the systematic transfer of technology related to gels production from the development or existing site to another manufacturing site, ensuring consistency, quality, and compliance throughout the transfer…
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SOP for Maintenance of Air Handling Units Standard Operating Procedure for Maintenance of Air Handling Units 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of air handling units to ensure the supply of clean and controlled air for pharmaceutical manufacturing environments. 2) Scope This SOP applies to…
SOP for Product Development for New Gel Formulations Standard Operating Procedure for Product Development for New Gel Formulations 1) Purpose The purpose of this SOP is to establish procedures for the systematic development of new gel formulations, from concept through to commercialization, ensuring that product development activities are conducted in a structured, efficient, and compliant…
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SOP for Root Cause Analysis Standard Operating Procedure for Root Cause Analysis 1) Purpose This SOP outlines the procedures for conducting root cause analysis (RCA) to systematically investigate and identify the underlying causes of deviations, incidents, non-conformances, or other quality issues within the pharmaceutical facility. 2) Scope This SOP applies to all departments and personnel…
SOP for Continuous Improvement in Gels Production Standard Operating Procedure for Continuous Improvement in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for fostering a culture of continuous improvement within the gels production department, aiming to systematically identify, prioritize, implement, and evaluate opportunities for enhancing processes, reducing waste, and improving…
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SOP for Change Management in Gels Production Standard Operating Procedure for Change Management in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for initiating, evaluating, approving, implementing, and documenting changes in gels production processes, ensuring controlled and systematic management of changes to maintain product quality, safety, and compliance with regulatory…