Author: Auditor

In-Process Control: SOP for Homogeneity Testing in Transdermal Patches

SOP for Homogeneity Testing in Transdermal Patches Procedure for Homogeneity Testing in Transdermal Patches 1) Purpose The purpose of this SOP is to outline the procedure for testing the homogeneity of transdermal patches to ensure uniform distribution of active pharmaceutical ingredients (APIs) and excipients. 2) Scope This SOP applies to all transdermal patches requiring homogeneity…

In-Process Control

SOP for Stability Data Management

SOP for Stability Data Management Standard Operating Procedure for Stability Data Management 1) Purpose This SOP outlines the procedures for managing stability data generated from stability studies to ensure accurate documentation, analysis, and reporting of data to support product shelf life and regulatory submissions. 2) Scope This SOP applies to all stability data generated from…

Quality Assurance

SOP for Supplier Corrective Action Requests

SOP for Supplier Corrective Action Requests Supplier Corrective Action Requests – Standard Operating Procedure 1) Purpose To establish guidelines for requesting corrective actions from suppliers to address non-conformances and improve performance within the pharmaceutical purchase department. 2) Scope This SOP applies to requesting and managing corrective actions requested from suppliers following non-conformance incidents. 3) Responsibilities…

Purchase Departments

SOP for Rheological Testing of Gels

SOP for Rheological Testing of Gels Procedure for Rheological Testing of Gels 1) Purpose The purpose of this SOP is to outline the procedure for performing rheological testing on gel pharmaceutical products to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all gel pharmaceutical products requiring rheological testing as part…

In-Process Control

SOP for Analytical Method Validation

SOP for Analytical Method Validation Standard Operating Procedure for Analytical Method Validation 1) Purpose This SOP outlines the procedures for validating analytical methods used in the testing of pharmaceutical products to ensure their accuracy, precision, specificity, robustness, and compliance with regulatory requirements. 2) Scope This SOP applies to all analytical methods used for the testing…

Quality Assurance

SOP for Taste Testing in Oral Liquids

SOP for Taste Testing in Oral Liquids Procedure for Taste Testing in Oral Liquids 1) Purpose The purpose of this SOP is to outline the procedure for testing the taste of oral liquid pharmaceutical products to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all oral liquid pharmaceutical products requiring…

In-Process Control

Injectables: SOP for Sterility Testing

SOP for Sterility Testing Standard Operating Procedure for Sterility Testing 1) Purpose The purpose of this SOP is to establish a standardized procedure for performing sterility testing of pharmaceutical products to ensure they are free from viable microorganisms. 2) Scope This SOP applies to all pharmaceutical products that require sterility testing within the facility, including…

Injectables

SOP for Computer System Validation

SOP for Computer System Validation Standard Operating Procedure for Computer System Validation 1) Purpose This SOP outlines the procedures for validating computer systems used in pharmaceutical manufacturing, testing, control, and documentation processes to ensure data integrity, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all computerized systems that manage or control…

Quality Assurance

SOP for Supplier Non-Conformance Handling

SOP for Supplier Non-Conformance Handling Supplier Non-Conformance Handling – Standard Operating Procedure 1) Purpose To establish guidelines for handling and resolving non-conformances related to materials or services supplied by vendors within the pharmaceutical purchase department. 2) Scope This SOP applies to handling non-conformances identified during supplier-related activities within the pharmaceutical purchase department. 3) Responsibilities Purchasing…

Purchase Departments

SOP for Odor Testing in Oral Liquids

SOP for Odor Testing in Oral Liquids Procedure for Odor Testing in Oral Liquids 1) Purpose The purpose of this SOP is to outline the procedure for testing the odor of oral liquid pharmaceutical products to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all oral liquid pharmaceutical products requiring…

In-Process Control