Author: Auditor

SOP for Calibration of Equipment in Ointment Formulation

SOP for Calibration of Equipment in Ointment Formulation Standard Operating Procedure for Calibration of Equipment in Ointment Formulation 1) Purpose The purpose of this SOP is to establish procedures for the calibration of equipment used in ointment formulation to ensure accuracy, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all equipment…

Ointments

SOP for Uniformity of Dosage Units

SOP for Uniformity of Dosage Units Procedure for Uniformity of Dosage Units Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the uniformity of dosage units (tablets) to ensure consistent distribution of the active pharmaceutical ingredient (API) among individual units. 2) Scope This SOP applies to all batches of…

In-Process Control

SOP for Stability Testing: Conducting Stability Tests to Determine the Shelf Life and Storage Conditions of the Capsules

SOP for Stability Testing: Conducting Stability Tests to Determine the Shelf Life and Storage Conditions of the Capsules Stability Testing Procedures for Capsules 1) Purpose The purpose of this SOP is to outline the procedure for conducting stability tests to determine the shelf life and appropriate storage conditions for capsules. 2) Scope This SOP applies…

Capsule Formulation

SOP for Capsule Dissolution Testing

SOP for Capsule Dissolution Testing Procedure for Capsule Dissolution Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the dissolution of capsules to ensure consistent release of the active pharmaceutical ingredient (API) over a specified time period. 2) Scope This SOP applies to all capsule batches produced within the…

In-Process Control

SOP for Labeling Verification: Ensuring That All Labels Are Accurate, Legible, and Compliant with Regulatory Requirements

SOP for Labeling Verification: Ensuring That All Labels Are Accurate, Legible, and Compliant with Regulatory Requirements Labeling Verification Procedures 1) Purpose The purpose of this SOP is to establish a standardized procedure for verifying that all labels are accurate, legible, and compliant with regulatory requirements. 2) Scope This SOP applies to all labeling activities within…

Capsule Formulation

SOP for Filtration of Solutions

SOP for Filtration of Solutions Standard Operating Procedure for Filtration of Solutions 1) Purpose The purpose of this SOP is to define the procedures for the filtration of solutions to ensure they are free of particulates and contaminants, and suitable for use in the manufacturing of injection products. 2) Scope This SOP applies to all…

Injectables

SOP for Capsule Disintegration Testing

SOP for Capsule Disintegration Testing Procedure for Capsule Disintegration Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the disintegration of capsules to ensure they break down into smaller particles or dissolve completely within the specified time frame for effective drug release. 2) Scope This SOP applies to all…

In-Process Control

SOP for Cleaning and Sanitization Procedures in Ointment Formulation

SOP for Cleaning and Sanitization Procedures in Ointment Formulation Standard Operating Procedure for Cleaning and Sanitization Procedures in Ointment Formulation 1) Purpose The purpose of this SOP is to establish procedures for the cleaning and sanitization of equipment and facilities used in ointment formulation to prevent contamination and ensure product quality and safety. 2) Scope…

Ointments

SOP for Packaging Inspection: Ensuring That Packaging Materials Are Free from Defects and That the Final Packaged Product Meets Quality Standards

SOP for Packaging Inspection: Ensuring That Packaging Materials Are Free from Defects and That the Final Packaged Product Meets Quality Standards Packaging Inspection Procedures 1) Purpose The purpose of this SOP is to define the procedure for inspecting packaging materials and ensuring that the final packaged product meets quality standards. 2) Scope This SOP applies…

Capsule Formulation

SOP for Capsule Content Uniformity

SOP for Capsule Content Uniformity Procedure for Capsule Content Uniformity Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the content uniformity of capsules to ensure consistent distribution of active pharmaceutical ingredient (API) across all dosage units. 2) Scope This SOP applies to all capsule batches produced within the…

In-Process Control