The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Cleaning and Sanitation Standard Operating Procedure for Cleaning and Sanitation 1) Purpose The purpose of this SOP is to establish procedures for the cleaning and sanitation of the manufacturing facility and equipment to ensure a hygienic environment and prevent contamination of pharmaceutical products. 2) Scope This SOP applies to all areas within the…
SOP for Paste Manufacturing Equipment Standard Operating Procedure for Paste Manufacturing Equipment 1) Purpose The purpose of this SOP is to provide guidelines for the operation and maintenance of equipment used in the manufacturing of dental pastes to ensure consistent product quality and compliance with regulatory standards. 2) Scope This SOP applies to all equipment…
SOP for Change Control Management Standard Operating Procedure for Change Control Management 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for initiating, documenting, reviewing, approving, and implementing changes within the pharmaceutical manufacturing facility to ensure compliance with regulatory requirements, maintain product quality, and manage risks effectively. 2) Scope This…
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SOP for Semi-Solid Dosage Form Production Standard Operating Procedure for Producing Semi-Solid Dosage Forms 1) Purpose The purpose of this SOP is to provide guidelines for the production of semi-solid dosage forms, such as ointments, gels, and creams, to ensure consistent quality and compliance with regulatory standards. 2) Scope This SOP applies to the entire…
SOP for HVAC System Validation Guidelines for HVAC System Validation in Vaginal Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for the validation of HVAC (Heating, Ventilation, and Air Conditioning) systems used in the manufacturing of vaginal dosage forms to ensure controlled environmental conditions. 2) Scope This SOP applies…
SOP for Friability Testing in Granules Standard Operating Procedure for Friability Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for conducting friability testing on granule formulations in the pharmaceutical industry to assess their resistance to abrasion and mechanical stress. 2) Scope This SOP applies to all personnel involved…
SOP for Water System Maintenance in MDI Production Water System Maintenance Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for the maintenance and operation of the water system in metered-dose inhaler (MDI) production to ensure quality, purity, and compliance with regulatory requirements. 2) Scope This SOP applies to…
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SOP for Emulsification Equipment Standard Operating Procedure for Emulsification Equipment 1) Purpose The purpose of this SOP is to ensure the proper operation and maintenance of emulsification equipment used in the manufacturing of dental dosage forms to achieve consistent emulsion stability and product quality. 2) Scope This SOP applies to all emulsification equipment used in…
SOP for Controlled Release Insert Manufacturing Standard Operating Procedure for Manufacturing Controlled Release Inserts 1) Purpose The purpose of this SOP is to provide guidelines for the manufacturing of controlled release inserts used in ocular dosage forms, ensuring consistent quality and efficacy. 2) Scope This SOP applies to the entire process of manufacturing controlled release…
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SOP for Equipment Qualification Guidelines for Equipment Qualification in Vaginal Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for the qualification of equipment used in the manufacturing of vaginal dosage forms to ensure their proper functioning and compliance with regulatory standards. 2) Scope This SOP applies to all equipment…
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