Pharma Stability: Insights, Guidelines, and Expertise
SOP for Implementing Stability Studies for Drug Products in Compliance with US FDA CFR Title 21 Standard Operating Procedure for Conducting Stability Studies Under US FDA CFR Title 21 1) Purpose The purpose of this SOP is to provide a standardized approach for conducting stability studies for drug products in compliance with US FDA CFR…
SOP for Preparing a Stability Protocol in Accordance with ICH Q1A(R2) Standard Operating Procedure for Preparing Stability Protocols Following ICH Q1A(R2) Guidelines 1) Purpose The purpose of this SOP is to provide a standardized procedure for preparing a stability protocol in compliance with the ICH Q1A(R2) guidelines to ensure the quality, safety, and efficacy of…
Read More “SOP for Preparing a Stability Protocol in Accordance with ICH Q1A(R2)” »
SOP for Conducting Stability Testing for Drug Products Under ASEAN Guidelines Standard Operating Procedure for Stability Testing Following ASEAN Guidelines 1) Purpose The purpose of this SOP is to establish a standardized approach for conducting stability testing for drug products in compliance with the ASEAN (Association of Southeast Asian Nations) guidelines to ensure their quality,…
Read More “SOP for Conducting Stability Testing for Drug Products Under ASEAN Guidelines” »
SOP for Performing Stability Studies Following EMA Guidelines Standard Operating Procedure for Stability Testing in Compliance with EMA Guidelines 1) Purpose The purpose of this SOP is to outline a procedure for conducting stability studies in compliance with the European Medicines Agency (EMA) guidelines to ensure that drug substances and products maintain their safety, quality,…
Read More “SOP for Performing Stability Studies Following EMA Guidelines” »
SOP for Reporting Stability Data in Common Technical Document (CTD) Format Standard Operating Procedure for Stability Data Reporting in CTD Format 1) Purpose The purpose of this SOP is to provide a standardized procedure for reporting stability data in the Common Technical Document (CTD) format for regulatory submissions to health authorities. 2) Scope This SOP…
Read More “SOP for Reporting Stability Data in Common Technical Document (CTD) Format” »
SOP for Conducting Bracketing and Matrixing Studies per ICH Q1D Standard Operating Procedure for Bracketing and Matrixing in Stability Studies Following ICH Q1D 1) Purpose The purpose of this SOP is to outline the procedure for conducting bracketing and matrixing in stability studies in compliance with ICH Q1D guidelines, optimizing the testing of multiple strengths…
Read More “SOP for Conducting Bracketing and Matrixing Studies per ICH Q1D” »
SOP for Ensuring Compliance with US FDA Stability Testing Requirements Standard Operating Procedure for Compliance with US FDA Stability Testing Requirements 1) Purpose The purpose of this SOP is to establish a standardized procedure for conducting stability testing of drug products to ensure compliance with US FDA stability testing requirements, thereby confirming the quality, safety,…
Read More “SOP for Ensuring Compliance with US FDA Stability Testing Requirements” »
SOP for Implementing Stability Testing for Export Products According to ICH Q1F Standard Operating Procedure for Stability Testing of Export Products Following ICH Q1F 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability testing for drug products intended for export to markets covered by ICH Q1F guidelines to…
Read More “SOP for Implementing Stability Testing for Export Products According to ICH Q1F” »
SOP for Interpreting ICH Q1B Photostability Testing Guidelines Standard Operating Procedure for Conducting Photostability Testing Following ICH Q1B 1) Purpose The purpose of this SOP is to provide guidance on conducting and interpreting photostability testing in accordance with ICH Q1B guidelines to ensure that drug substances and products are not adversely affected by exposure to…
Read More “SOP for Interpreting ICH Q1B Photostability Testing Guidelines” »
SOP for Conducting Stability Testing in Accordance with WHO Guidelines Standard Operating Procedure for Stability Testing Following WHO Guidelines 1) Purpose The purpose of this SOP is to establish a procedure for conducting stability testing in compliance with the World Health Organization (WHO) guidelines to ensure the safety, efficacy, and quality of pharmaceutical products. 2)…
Read More “SOP for Conducting Stability Testing in Accordance with WHO Guidelines” »