Author: Auditor

SOP for Visual Inspection of Transdermal Patches

SOP for Visual Inspection of Transdermal Patches Standard Operating Procedure for Visual Inspection of Transdermal Patches 1) Purpose To define procedures for visually inspecting transdermal patches to ensure they meet quality standards and specifications before release for packaging. 2) Scope This SOP applies to the quality control department responsible for conducting visual inspections of transdermal…

Transdermal Patches

SOP for Packaging of MDIs

SOP for Packaging of MDIs MDI Packaging Procedures 1) Purpose The purpose of this SOP is to define the packaging procedures for metered-dose inhalers (MDIs) to ensure product integrity, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the packaging of MDIs at the manufacturing facility, including packaging…

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Metered-Dose Inhaler

SOP for Distribution and Transport Conditions for Transdermal Patches

SOP for Distribution and Transport Conditions for Transdermal Patches Standard Operating Procedure for Distribution and Transport Conditions for Transdermal Patches 1) Purpose To establish procedures for the proper distribution and transport of transdermal patches to ensure product integrity, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to the logistics and distribution department…

Transdermal Patches

SOP for Process Optimization for Lotions

SOP for Process Optimization for Lotions Standard Operating Procedure for Process Optimization for Lotions 1) Purpose The purpose of this SOP is to outline procedures for optimizing the manufacturing processes of lotions to improve efficiency, quality, and consistency. 2) Scope This SOP applies to all personnel involved in the manufacturing and process optimization of lotions…

Lotions

SOP for Suppository Packaging Machine

SOP for Suppository Packaging Machine Operation and Maintenance of Suppository Packaging Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository packaging machine to ensure efficient and accurate packaging of suppositories. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance…

Vaginal Dosage Forms

SOP for Granulation Techniques

SOP for Granulation Techniques Standard Operating Procedure for Granulation Techniques 1) Purpose The purpose of this SOP is to provide a standardized procedure for the different granulation techniques used in pharmaceutical manufacturing to ensure consistency, quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the granulation process within…

Powder & Granules

SOP for Pharmacovigilance Stakeholder Communication

SOP for Pharmacovigilance Stakeholder Communication Guidelines for Pharmacovigilance Stakeholder Communication 1) Purpose The purpose of this SOP is to establish procedures for effective communication with stakeholders involved in pharmacovigilance activities to ensure transparency, compliance, and timely exchange of information. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for communicating with internal and external…

Pharmacovigilance

Injectables: SOP for Validation of Analytical Methods

SOP for Validation of Analytical Methods Standard Operating Procedure for Validation of Analytical Methods 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the validation of analytical methods used in the analysis of pharmaceutical products to ensure accuracy, reliability, and reproducibility of results. 2) Scope This SOP applies…

Injectables

SOP for Label Inspection for Transdermal Patches

SOP for Label Inspection for Transdermal Patches Standard Operating Procedure for Label Inspection for Transdermal Patches 1) Purpose To define procedures for inspecting labels used in the packaging of transdermal patches to ensure accuracy, consistency, and compliance with regulatory requirements. 2) Scope This SOP applies to the quality control department responsible for inspecting labels during…

Transdermal Patches

SOP for Formulation Development for Lotions

SOP for Formulation Development for Lotions Standard Operating Procedure for Formulation Development for Lotions 1) Purpose The purpose of this SOP is to establish procedures for the development and optimization of lotion formulations to achieve desired product characteristics and performance. 2) Scope This SOP applies to all personnel involved in the formulation development of lotions…

Lotions