Tag: Stability studies

Include Container Torque and Closure Integrity Testing in Stability

Understanding the Tip: Why closure integrity matters during stability studies: Container-closure systems serve as the first line of protection for pharmaceutical products. If the seal loosens or fails during storage, it can lead to evaporation, contamination, degradation, or even microbial ingress. Torque and closure integrity testing ensure that screw caps, crimped seals, flip-off caps, and…

Stability Study Tips

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

Include Extractables and Leachables Testing in Stability Protocols When Needed

Understanding the Tip: Why extractables and leachables (E&L) matter in stability: Extractables are compounds that can be released from packaging materials under aggressive conditions, while leachables are those that migrate into the product under actual storage conditions. When left unchecked, these compounds can compromise drug purity, potency, and safety. E&L testing during stability ensures the…

Stability Study Tips

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

SOP for Implementing Stability Testing for High-Risk Drug Products under Regulatory Guidelines

SOP for Implementing Stability Testing for High-Risk Drug Products under Regulatory Guidelines Procedure for Stability Testing of High-Risk Drug Products 1) Purpose The purpose of this SOP is to establish a procedure for conducting stability testing of high-risk drug products in compliance with relevant regulatory guidelines. This ensures that these products maintain their safety, efficacy,…

Stability Studies SOP