The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Microbial Testing in Powders Standard Operating Procedure for Microbial Testing in Powders 1) Purpose The purpose of this SOP is to outline the procedure for conducting microbial testing on powder formulations in the pharmaceutical industry to ensure compliance with microbiological quality standards. 2) Scope This SOP applies to all personnel involved in the…
SOP for Personnel Training and Qualification Standard Operating Procedure for Employee Training and Qualification 1) Purpose The purpose of this SOP is to establish a procedure for training and qualifying personnel to ensure they are competent to perform their assigned duties in compliance with regulatory requirements and company standards. 2) Scope This SOP applies to…
SOP for Control of Non-Conforming Materials Standard Operating Procedure for Control of Non-Conforming Materials 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for identifying, segregating, evaluating, and dispositioning non-conforming materials within the pharmaceutical manufacturing facility to prevent unintended use or distribution. 2) Scope This SOP applies to all non-conforming…
SOP for Suppository Cooling Rack Operation and Maintenance of Suppository Cooling Rack 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository cooling rack to ensure effective cooling and solidification of suppositories during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the…
SOP for Sterile Eye Drop Production Line Standard Operating Procedure for Sterile Eye Drop Manufacturing Line 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Sterile Eye Drop Production Line used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to…
SOP for Pharmacovigilance System Maintenance Guidelines for Pharmacovigilance System Maintenance 1) Purpose The purpose of this SOP is to outline procedures for the ongoing maintenance and support of pharmacovigilance systems to ensure continuous functionality, data integrity, and compliance with regulatory requirements. 2) Scope This SOP applies to personnel responsible for pharmacovigilance system maintenance, including IT…
SOP for Homogeneity Testing in Granules Standard Operating Procedure for Homogeneity Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for conducting homogeneity testing on granule formulations in the pharmaceutical industry to ensure uniform distribution of the active pharmaceutical ingredient (API) and excipients. 2) Scope This SOP applies to…
SOP for Use of Solvents in MDI Production Solvent Handling Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for the safe handling and use of solvents in metered-dose inhaler (MDI) production to ensure operator safety, product quality, and compliance with regulatory requirements. 2) Scope This SOP applies to…
SOP for Ring Quality Inspection Unit Operation and Maintenance of Ring Quality Inspection Unit 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring quality inspection unit to ensure thorough inspection of rings during the manufacturing process. 2) Scope This SOP applies to all personnel involved in…
SOP for Gel Mixing Equipment Standard Operating Procedure for Gel Mixing System 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Gel Mixing Equipment used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to the Gel Mixing Equipment used in…