The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Packaging of Granules Standard Operating Procedure for Granule Packaging 1) Purpose The purpose of this SOP is to provide a standardized procedure for the packaging of granules in the pharmaceutical manufacturing process to ensure product integrity, quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the…
SOP for Suppository Trimming Machine Operation and Maintenance of Suppository Trimming Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository trimming machine to ensure accurate and efficient trimming of suppositories. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance…
SOP for Pharmacovigilance Investigator Initiated Studies (IIS) Guidelines for Pharmacovigilance Investigator Initiated Studies (IIS) 1) Purpose The purpose of this SOP is to establish procedures for the management and pharmacovigilance oversight of Investigator Initiated Studies (IIS) conducted by external investigators. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for reviewing, monitoring, and reporting…
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SOP for Stability Testing of MDIs MDI Stability Testing Procedures 1) Purpose The purpose of this SOP is to outline the procedures for conducting stability testing of metered-dose inhalers (MDIs) to ensure they maintain their quality, safety, and efficacy throughout their shelf life. 2) Scope This SOP applies to all personnel involved in the stability…
SOP for Application Site Testing for Transdermal Patches Standard Operating Procedure for Application Site Testing for Transdermal Patches 1) Purpose To establish procedures for conducting application site testing of transdermal patches to evaluate skin reactions and ensure product safety. 2) Scope This SOP applies to the clinical research or quality control departments responsible for conducting…
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SOP for Ring Sterilization Unit Operation and Maintenance of Ring Sterilization Unit 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring sterilization unit to ensure effective sterilization of rings. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the…
SOP for Packaging of Powders Standard Operating Procedure for Powder Packaging 1) Purpose The purpose of this SOP is to provide a standardized procedure for the packaging of powders in the pharmaceutical manufacturing process to ensure product integrity, quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the…
SOP for Moisture Content Testing in Transdermal Patches Standard Operating Procedure for Moisture Content Testing in Transdermal Patches 1) Purpose To establish procedures for determining the moisture content in transdermal patches to ensure product stability and quality. 2) Scope This SOP applies to the quality control department responsible for performing moisture content testing on transdermal…
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SOP for Label Control and Accountability Standard Operating Procedure for Label Control and Accountability 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for controlling and maintaining accountability of labels used in pharmaceutical manufacturing to ensure accurate labeling of products. 2) Scope This SOP applies to all personnel involved…
SOP for Residual Solvent Testing in Transdermal Patches Standard Operating Procedure for Residual Solvent Testing in Transdermal Patches 1) Purpose To establish procedures for testing residual solvents in transdermal patches to ensure compliance with safety and regulatory requirements. 2) Scope This SOP applies to the quality control department responsible for performing residual solvent testing on…
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