Tag: Photostability testing

SOP for Conducting Stability Testing for Biosimilars in Compliance with WHO Guidelines

SOP for Conducting Stability Testing for Biosimilars in Compliance with WHO Guidelines Procedure for Stability Testing of Biosimilars 1) Purpose The purpose of this SOP is to establish a procedure for conducting stability testing for biosimilar products in compliance with the World Health Organization (WHO) guidelines. This ensures that biosimilars maintain their quality, safety, and…

Stability Studies SOP

SOP for Implementing Stability Testing for Pediatric Formulations under US FDA and EMA Guidelines

SOP for Implementing Stability Testing for Pediatric Formulations under US FDA and EMA Guidelines Procedure for Stability Testing of Pediatric Formulations 1) Purpose The purpose of this SOP is to define the procedures for conducting stability testing for pediatric formulations in compliance with US FDA and EMA guidelines. This ensures that pediatric formulations maintain their…

Stability Studies SOP

SOP for Conducting Stability Studies for Drug Products Stored at Subzero Temperatures under Regulatory Guidelines

SOP for Conducting Stability Studies for Drug Products Stored at Subzero Temperatures under Regulatory Guidelines Procedure for Stability Testing of Drug Products Stored at Subzero Temperatures 1) Purpose The purpose of this SOP is to establish a procedure for conducting stability studies for drug products stored at subzero temperatures in compliance with relevant regulatory guidelines….

Stability Studies SOP

SOP for Implementing Stability Testing for Polymorphic Drug Substances under Regulatory Guidelines

SOP for Implementing Stability Testing for Polymorphic Drug Substances under Regulatory Guidelines Procedure for Stability Testing of Polymorphic Drug Substances 1) Purpose The purpose of this SOP is to define a procedure for conducting stability testing for polymorphic drug substances in compliance with relevant regulatory guidelines. This ensures that polymorphic substances maintain their intended form,…

Stability Studies SOP

SOP for Addressing Stability Testing Requirements for Global Harmonization under ICH Guidelines

SOP for Addressing Stability Testing Requirements for Global Harmonization under ICH Guidelines Procedure for Stability Testing for Global Harmonization 1) Purpose The purpose of this SOP is to define a procedure for conducting stability testing to meet global harmonization requirements as outlined by the International Council for Harmonisation (ICH) guidelines. This ensures that drug products…

Stability Studies SOP

SOP for Implementing Stability Testing for Orally Inhaled and Nasal Drug Products (OINDP) under FDA Guidelines

SOP for Implementing Stability Testing for Orally Inhaled and Nasal Drug Products (OINDP) under FDA Guidelines Procedure for Stability Testing of Orally Inhaled and Nasal Drug Products 1) Purpose The purpose of this SOP is to define a procedure for conducting stability testing for orally inhaled and nasal drug products (OINDP) in accordance with US…

Stability Studies SOP

SOP for Conducting Stability Studies for Controlled Drugs under Regulatory Guidelines

SOP for Conducting Stability Studies for Controlled Drugs under Regulatory Guidelines Procedure for Stability Testing of Controlled Drugs 1) Purpose The purpose of this SOP is to establish a procedure for conducting stability studies for controlled drugs in compliance with relevant regulatory guidelines. This ensures that controlled substances maintain their quality, safety, and efficacy throughout…

Stability Studies SOP

Common Calibration Errors with UV Light Sensors in Photostability Testing

Photostability testing, as mandated by ICH Q1B, relies heavily on accurate and traceable UV light exposure. However, even with modern digital sensors and SOPs, UV light meter calibration remains an overlooked vulnerability in many pharmaceutical stability programs. Missteps in this area can lead to GMP non-compliance, rejected batches, or even data integrity violations during regulatory…

Equipment and Calibration

SOP for Addressing Stability Testing for Products under Emergency Use Authorization (EUA)

SOP for Addressing Stability Testing for Products under Emergency Use Authorization (EUA) Procedure for Stability Testing of Products under Emergency Use Authorization 1) Purpose The purpose of this SOP is to establish a procedure for conducting stability testing for products under Emergency Use Authorization (EUA) in compliance with regulatory guidelines. This ensures that products maintain…

Stability Studies SOP

Checklist for Ensuring Accurate UV Intensity Measurement in Stability Chambers

Accurate UV intensity measurement is a critical element in pharmaceutical stability chamber performance, especially when dealing with photostability testing as per ICH Q1B guidelines. Regulatory audits frequently focus on the accuracy and traceability of UV exposure data. Even small calibration drifts in UV sensors can lead to non-compliance and potential product rejection. This article provides…

Equipment and Calibration