The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Use of Stabilizers in Aerosol Production Standard Operating Procedure for Use of Stabilizers in Aerosol Production 1) Purpose The purpose of this SOP is to establish procedures for the proper use and incorporation of stabilizers in aerosol formulations. Stabilizers ensure product stability, quality, and performance throughout manufacturing and storage. 2) Scope This SOP…
Read More “SOP for Use of Stabilizers in Aerosol Production” »
SOP for Formulation Development Stability Protocol Development Developing Stability Protocols in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for developing stability protocols during the formulation development process, ensuring that stability studies are designed and conducted to support product quality and shelf-life determination. 2) Scope This SOP applies to…
Read More “SOP for Formulation Development Stability Protocol Development” »
SOP for Analytical Method Development Method Transfer Execution Executing Method Transfer for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for executing the method transfer during the analytical method development process, ensuring successful transfer of validated methods between laboratories or sites. 2) Scope This SOP applies to all…
Read More “SOP for Analytical Method Development Method Transfer Execution” »
SOP for Pharmacovigilance Data Coding Guidelines for Coding Pharmacovigilance Data 1) Purpose The purpose of this SOP is to define the procedures for coding pharmacovigilance data to ensure standardized and accurate classification of safety information. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the coding of safety data, including data entry operators,…
SOP for Formulation Development Regulatory Filing Regulatory Filing Process in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for filing regulatory submissions during the formulation development process, ensuring compliance with regulatory requirements and facilitating the approval of products for market entry. 2) Scope This SOP applies to all formulation…
Read More “SOP for Formulation Development Regulatory Filing” »
SOP for Use of Propellants in Aerosol Production Standard Operating Procedure for Use of Propellants in Aerosol Production 1) Purpose The purpose of this SOP is to outline procedures for handling and using propellants in aerosol production processes. Proper handling ensures safety, quality, and regulatory compliance throughout the manufacturing process. 2) Scope This SOP applies…
Read More “SOP for Use of Propellants in Aerosol Production” »
SOP for Maintenance of Vacuum Systems Standard Operating Procedure for Maintenance of Vacuum Systems 1) Purpose The purpose of this SOP is to establish guidelines for the maintenance and operation of vacuum systems in pharmaceutical manufacturing facilities to ensure efficient and reliable operation in critical processes. 2) Scope This SOP applies to all vacuum systems…
SOP for Analytical Method Development Method Transfer Protocol Preparation Preparing Method Transfer Protocol for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for preparing the method transfer protocol during the analytical method development process, ensuring systematic transfer of validated methods between laboratories or sites. 2) Scope This SOP…
Read More “SOP for Analytical Method Development Method Transfer Protocol Preparation” »
SOP for Formulation Development Regulatory Submission Preparation Preparing Regulatory Submissions in Formulation Development 1) Purpose The purpose of this SOP is to outline the procedure for preparing regulatory submissions during the formulation development process, ensuring compliance with regulatory requirements and facilitating timely approvals. 2) Scope This SOP applies to all formulation development projects within the…
Read More “SOP for Formulation Development Regulatory Submission Preparation” »
SOP for Sample Collection during FFS Operations Standard Operating Procedure for Sample Collection during Form-Fill-Seal (FFS) Operations 1) Purpose The purpose of this SOP is to define procedures for collecting representative samples during Form-Fill-Seal (FFS) operations to ensure product quality and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in…
Read More “SOP for Sample Collection during FFS Operations” »