The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Pyrogen Testing Procedure for Pyrogen Testing 1) Purpose The purpose of this SOP is to outline the procedure for performing pyrogen testing on pharmaceutical products to ensure they are free from pyrogenic contaminants and safe for patient use. 2) Scope This SOP applies to all pharmaceutical products manufactured within the facility that require…
SOP for Document Control: Procedures for Managing the Creation, Approval, Distribution, and Archiving of Documents Document Control Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for managing the creation, approval, distribution, and archiving of documents to ensure accurate and up-to-date documentation within the pharmaceutical manufacturing facility. 2) Scope This SOP…
SOP for Sealing and Capping of Vials Standard Operating Procedure for Sealing and Capping of Vials 1) Purpose The purpose of this SOP is to define the procedures for sealing and capping vials to ensure the integrity and sterility of injection products. 2) Scope This SOP applies to all personnel involved in sealing and capping…
SOP for Sterility Testing Procedure for Sterility Testing 1) Purpose The purpose of this SOP is to outline the procedure for performing sterility testing on pharmaceutical products to ensure they are free from viable microorganisms and safe for patient use. 2) Scope This SOP applies to all pharmaceutical products manufactured within the facility that require…
SOP for Cleaning and Sanitation: Procedures for Cleaning and Sanitizing Equipment and Facilities Cleaning and Sanitation Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for cleaning and sanitizing equipment and facilities to ensure a hygienic manufacturing environment and prevent contamination. 2) Scope This SOP applies to all equipment and facilities…
SOP for Endotoxin Testing in Injectable Products Procedure for Endotoxin Testing in Injectable Products 1) Purpose The purpose of this SOP is to outline the procedure for conducting endotoxin testing on injectable products to ensure compliance with regulatory requirements and patient safety. 2) Scope This SOP applies to all injectable products manufactured within the facility…
Read More “SOP for Endotoxin Testing in Injectable Products” »
SOP for Investigation and CAPA in Ointment Formulation Standard Operating Procedure for Investigation and Corrective Action Preventive Action (CAPA) in Ointment Formulation 1) Purpose The purpose of this SOP is to establish procedures for conducting investigations, implementing corrective actions, and preventive actions (CAPA) related to deviations, incidents, complaints, or non-conformances in ointment formulation processes or…
Read More “SOP for Investigation and CAPA in Ointment Formulation” »
SOP for Change Control: Procedures for Managing Changes to Processes, Equipment, or Procedures Change Control Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for managing changes to processes, equipment, or procedures to ensure that all changes are properly evaluated, documented, and implemented without negatively impacting product quality. 2) Scope This…
SOP for Lyophilization Process Standard Operating Procedure for Lyophilization Process 1) Purpose The purpose of this SOP is to define the procedures for the lyophilization (freeze-drying) process to ensure the stability and sterility of injection products. 2) Scope This SOP applies to all personnel involved in the lyophilization process at [Company Name] for the production…
SOP for Osmolality Testing Procedure for Osmolality Testing 1) Purpose The purpose of this SOP is to outline the procedure for measuring the osmolality of liquid samples used in pharmaceutical manufacturing to ensure proper formulation and patient safety. 2) Scope This SOP applies to all liquid formulations produced within the manufacturing facility that require osmolality…