The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Preparation of Solutions Standard Operating Procedure for Preparation of Solutions 1) Purpose The purpose of this SOP is to outline the procedures for the preparation of solutions to ensure their quality and consistency for use in the manufacturing of injection products. 2) Scope This SOP applies to all personnel involved in the preparation…
SOP for Batch Release Procedures in Ointment Formulation Standard Operating Procedure for Batch Release Procedures in Ointment Formulation 1) Purpose The purpose of this SOP is to define procedures for the release of finished batches of ointment products, ensuring they meet all quality standards before distribution or use. 2) Scope This SOP applies to all…
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SOP for Taste and Odor Evaluation: Sensory Evaluation to Confirm That Capsules Do Not Have Objectionable Taste or Odor Procedures for Taste and Odor Evaluation of Capsules 1) Purpose The purpose of this SOP is to establish a standardized procedure for conducting sensory evaluations to confirm that capsules do not have objectionable taste or odor….
SOP for Tablet Dissolution Testing Procedure for Tablet Dissolution Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the dissolution of tablets to ensure consistent release of the active pharmaceutical ingredient (API) over a specified time period. 2) Scope This SOP applies to all tablet batches produced within the…
SOP for Sealing Integrity Check: Ensuring That the Capsules Are Properly Sealed to Prevent Leakage and Maintain Product Integrity Sealing Integrity Check Procedures for Capsules 1) Purpose The purpose of this SOP is to outline the procedure for ensuring that capsules are properly sealed to prevent leakage and maintain product integrity. 2) Scope This SOP…
SOP for Tablet Disintegration Testing Procedure for Tablet Disintegration Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the disintegration of tablets to ensure they dissolve completely within the specified time frame for effective drug release. 2) Scope This SOP applies to all tablet batches produced within the manufacturing…
SOP for Process Validation in Ointment Formulation Standard Operating Procedure for Process Validation in Ointment Formulation 1) Purpose The purpose of this SOP is to establish procedures for process validation in ointment formulation to ensure consistency, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all stages of the ointment formulation process,…
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SOP for Sterilization of Manufacturing Equipment Standard Operating Procedure for Sterilization of Manufacturing Equipment 1) Purpose The purpose of this SOP is to define the procedures for sterilizing manufacturing equipment to ensure a sterile production environment and prevent contamination of injection products. 2) Scope This SOP applies to all personnel involved in the sterilization of…
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SOP for Moisture Content Control: Monitoring and Controlling Moisture Levels in Capsules to Prevent Issues with Stability or Dissolution Moisture Content Monitoring and Control Procedures 1) Purpose The purpose of this SOP is to establish a standardized procedure for monitoring and controlling moisture levels in capsules to ensure product stability and proper dissolution. 2) Scope…
SOP for Tablet Friability Testing Procedure for Tablet Friability Testing 1) Purpose The purpose of this SOP is to outline the procedure for determining the friability of tablets to ensure they have adequate mechanical strength to withstand handling and transportation. 2) Scope This SOP applies to all tablet batches produced within the manufacturing facility. 3)…