The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Gel Storage Unit Operation and Maintenance of Gel Storage Unit 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel storage unit to ensure proper storage conditions for gel formulations during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the…
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SOP for Assay of Active Ingredient in Powders Standard Operating Procedure for Assay of Active Ingredient in Powders 1) Purpose The purpose of this SOP is to outline the procedure for conducting assay testing of the active pharmaceutical ingredient (API) in powder formulations to ensure the potency and quality of the product. 2) Scope This…
SOP for Batch Reconciliation in MDI Production Batch Reconciliation Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for batch reconciliation in metered-dose inhaler (MDI) production to ensure accurate accounting of materials, components, and documentation throughout the manufacturing process. 2) Scope This SOP applies to all personnel involved in…
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SOP for Aseptic Processing Area Standard Operating Procedure for Aseptic Processing Area Management 1) Purpose The purpose of this SOP is to provide a detailed procedure for the management and operation of the Aseptic Processing Area used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to the Aseptic Processing Area utilized…
SOP for Health and Hygiene Requirements Standard Operating Procedure for Health and Hygiene Standards 1) Purpose The purpose of this SOP is to define the health and hygiene requirements to ensure a clean and safe working environment in compliance with regulatory standards and to prevent contamination during manufacturing processes. 2) Scope This SOP applies to…
SOP for Cream Cooling Jacket Operation and Maintenance of Cream Cooling Jacket 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the cream cooling jacket to ensure proper cooling of cream formulations during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation,…
SOP for Laminar Air Flow Hood Standard Operating Procedure for Laminar Air Flow Hood Operation 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Laminar Air Flow Hood used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to the Laminar…
SOP for Microbial Testing in Granules Standard Operating Procedure for Microbial Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for conducting microbial testing on granule 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 Pharmacovigilance Case Narratives Review Guidelines for Pharmacovigilance Case Narratives Review 1) Purpose The purpose of this SOP is to define procedures for reviewing and assessing pharmacovigilance case narratives to ensure accuracy, completeness, and compliance with regulatory requirements. 2) Scope This SOP applies to personnel responsible for reviewing pharmacovigilance case narratives, including pharmacovigilance scientists,…
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SOP for Tablet Dehumidifier Operation and Maintenance of Tablet Dehumidifier 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet dehumidifier to ensure optimal moisture levels in tablets during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance…