The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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…
Read More “SOP for Technology Transfer in Gels Production” »
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…
Read More “SOP for Product Development for New Gel Formulations” »
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…
Read More “SOP for Continuous Improvement in Gels Production” »
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…
SOP for Risk Management in Gels Production Standard Operating Procedure for Risk Management in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for identifying, assessing, controlling, and mitigating risks associated with gels production processes, aiming to ensure product quality, patient safety, and compliance with regulatory requirements. 2) Scope This SOP…
SOP for Corrective and Preventive Actions (CAPA) in Gels Production Standard Operating Procedure for Corrective and Preventive Actions (CAPA) in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, investigating, implementing, and verifying corrective and preventive actions (CAPA) in response to deviations, non-conformances, complaints, or other quality issues…
Read More “SOP for Corrective and Preventive Actions (CAPA) in Gels Production” »
SOP for Root Cause Analysis in Gels Production Standard Operating Procedure for Root Cause Analysis in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for conducting effective root cause analysis (RCA) of deviations, non-conformances, or quality issues encountered during gels production, aiming to identify underlying causes and implement corrective actions…
Read More “SOP for Root Cause Analysis in Gels Production” »
SOP for Out of Specification (OOS) Handling in Gels Production Standard Operating Procedure for Out of Specification (OOS) Handling in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the identification, investigation, and handling of Out of Specification (OOS) results encountered during gels production, ensuring accurate data interpretation, product quality…
Read More “SOP for Out of Specification (OOS) Handling in Gels Production” »
SOP for Deviation Handling in Gels Production Standard Operating Procedure for Deviation Handling in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations that occur during gels production, ensuring product quality, process integrity, and compliance with regulatory requirements. 2) Scope This SOP…
SOP for Process Validation Protocols for Gels Standard Operating Procedure for Process Validation Protocols for Gels 1) Purpose The purpose of this SOP is to define the procedures for conducting process validation protocols for gels production to ensure consistent product quality, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all stages…