Standard Operating Procedure for Stability Study Sampling Plan Execution Purpose The purpose of this SOP is to establish procedures for the execution of the sampling plan in stability studies conducted in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the collection and management of stability study samples. Responsibilities Quality Assurance: Responsible for…
ICH stability guidelines
SOP for Stability Study Sampling Plan Development
Standard Operating Procedure for Stability Study Sampling Plan Development Purpose The purpose of this SOP is to establish procedures for the development of a sampling plan for stability studies conducted in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the planning and execution of stability studies for pharmaceutical products. Responsibilities Quality Assurance:…
SOP for Stability Study Analytical Method Validation
Standard Operating Procedure for Stability Study Analytical Method Validation Purpose The purpose of this SOP is to establish procedures for the validation of analytical methods used in stability studies for pharmaceutical products. Scope This SOP applies to all personnel involved in the development and execution of stability study analytical methods. Responsibilities Quality Assurance: Responsible for…
SOP for Monitoring Stability Study Storage Condition
Standard Operating Procedure for Stability Study Storage Condition Monitoring Purpose The purpose of this SOP is to establish procedures for the monitoring and control of storage conditions during stability studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the storage and monitoring of pharmaceutical products undergoing stability studies. Responsibilities Quality Assurance:…
SOP for Stability Study Sample Management
Standard Operating Procedure for Stability Study Sample Management Purpose The purpose of this SOP is to establish the procedures for the proper management of stability study samples in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the collection, labeling, storage, and disposal of stability study samples conducted as part of the pharmaceutical…
SOP for Stability Chamber Qualification
Standard Operating Procedure for Stability Chamber Qualification Purpose The purpose of this SOP is to establish the procedures for the qualification of stability chambers used in the pharmaceutical industry. Scope This SOP applies to all stability chambers used for the storage of pharmaceutical products at various conditions to assess their stability over time. Responsibilities Quality Assurance:…