The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Microbial Testing of MDIs MDI Microbial Testing Procedures 1) Purpose The purpose of this SOP is to establish the procedures for conducting microbial testing of metered-dose inhalers (MDIs) to ensure they meet microbiological quality standards and are safe for use. 2) Scope This SOP applies to all personnel involved in the microbial testing…
SOP for Tablet Deduster Operation and Maintenance of Tablet Deduster 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet deduster to ensure efficient removal of dust and particles from tablets. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…
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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