Author: Auditor

SOP for Pharmacovigilance Data Retention and Destruction

SOP for Pharmacovigilance Data Retention and Destruction Guidelines for Pharmacovigilance Data Retention and Destruction 1) Purpose The purpose of this SOP is to establish procedures for the retention and secure destruction of pharmacovigilance data in compliance with regulatory requirements and company policies. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the collection,…

Pharmacovigilance

SOP for Product Release Testing for Transdermal Patches

SOP for Product Release Testing for Transdermal Patches Standard Operating Procedure for Product Release Testing for Transdermal Patches 1) Purpose To establish a standardized procedure for conducting product release testing on transdermal patches to ensure they meet predefined quality standards before release to the market. 2) Scope This SOP applies to the quality control (QC)…

Transdermal Patches

SOP for Cleaning Validation for Filling Equipment

SOP for Cleaning Validation for Filling Equipment Standard Operating Procedure for Cleaning Validation for Filling Equipment 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for validating the cleaning process of filling equipment used in pharmaceutical manufacturing to prevent cross-contamination and ensure product quality and safety. 2) Scope This…

Injectables

SOP for Gel Filling Machine

SOP for Gel Filling Machine Operation and Maintenance of Gel Filling Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel filling machine to ensure accurate filling of gel products with consistent quality. 2) Scope This SOP applies to all personnel involved in the operation, cleaning,…

Vaginal Dosage Forms

SOP for Light Exposure Testing for Transdermal Patches

SOP for Light Exposure Testing for Transdermal Patches Standard Operating Procedure for Light Exposure Testing for Transdermal Patches 1) Purpose To establish a standardized procedure for conducting light exposure testing on transdermal patches to evaluate their stability and performance under light exposure conditions. 2) Scope This SOP applies to the quality control (QC) and quality…

Transdermal Patches

SOP for Cleaning of Equipment Used for Lotions

SOP for Cleaning of Equipment Used for Lotions Standard Operating Procedure for Cleaning of Equipment Used for Lotions 1) Purpose The purpose of this SOP is to outline the procedure for cleaning equipment used in the manufacturing of lotions to prevent cross-contamination, ensure product quality, and maintain regulatory compliance. 2) Scope This SOP applies to…

Lotions

SOP for Freeze-Thaw Stability Testing for Transdermal Patches

SOP for Freeze-Thaw Stability Testing for Transdermal Patches Standard Operating Procedure for Freeze-Thaw Stability Testing for Transdermal Patches 1) Purpose To establish a standardized procedure for conducting freeze-thaw stability testing on transdermal patches to evaluate their stability and performance after exposure to freezing and thawing conditions. 2) Scope This SOP applies to the quality control…

Transdermal Patches

SOP for Storage Conditions of Lotions

SOP for Storage Conditions of Lotions Standard Operating Procedure for Storage Conditions of Lotions 1) Purpose The purpose of this SOP is to define the appropriate storage conditions for lotions to maintain their stability, integrity, and efficacy throughout their shelf life. 2) Scope This SOP applies to all personnel involved in the handling, storage, and…

Lotions

SOP for Temperature Cycling Testing for Transdermal Patches

SOP for Temperature Cycling Testing for Transdermal Patches Standard Operating Procedure for Temperature Cycling Testing for Transdermal Patches 1) Purpose To establish a standardized procedure for conducting temperature cycling testing on transdermal patches to assess their stability and performance under varying temperature conditions. 2) Scope This SOP applies to the quality control (QC) and quality…

Transdermal Patches

SOP for Cream Homogenizer

SOP for Cream Homogenizer Operation and Maintenance of Cream Homogenizer 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the cream homogenizer to ensure the production of homogenous cream products with consistent quality. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance…

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Vaginal Dosage Forms