Pharma Stability: Insights, Guidelines, and Expertise
SOP for Designing Stability Studies for Drug Products with Extended Shelf Life under Regulatory Guidelines Guidelines for Stability Testing of Drug Products with Extended Shelf Life as per Regulatory Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for designing stability studies for drug products with extended shelf life…
SOP for Conducting Stability Testing for Advanced Therapy Medicinal Products (ATMPs) per EMA Guidelines Guidelines for Stability Testing of ATMPs as per EMA Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for Advanced Therapy Medicinal Products (ATMPs) in accordance with European Medicines Agency (EMA)…
Understanding the Tip: Why CAPA is essential for excursion management: Temperature or humidity excursions during storage, transport, or chamber operation can compromise the validity of a stability study. If not properly addressed, these deviations may impact product quality and create regulatory risk. A CAPA (Corrective and Preventive Action) system ensures that such events are systematically…
Read More “Manage Stability Excursions Effectively Using CAPA Systems” »
SOP for Implementing Stability Testing for Drugs with Novel Delivery Systems under US FDA Guidelines Guidelines for Stability Testing of Drugs with Novel Delivery Systems as per US FDA Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for drugs with novel delivery systems in…
Understanding the Tip: Why simulate transport conditions during stability studies: Pharmaceuticals often travel through complex distribution channels—facing vibration, shocks, temperature spikes, and humidity fluctuations. While chamber stability simulates storage, it doesn’t capture the physical stress of transport. Including stability samples in mock shipments replicates these distribution hazards and verifies product resilience before market launch. This…
Read More “Include Stability Samples in Mock Transport to Simulate Distribution Stress” »
SOP for Conducting Stability Studies for Drug Products in Compliance with Indian Regulatory Requirements (CDSCO) Guidelines for Stability Testing of Drug Products as per Indian Regulatory Requirements (CDSCO) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability studies for drug products in accordance with the Central Drugs…
Understanding the Tip: Why moisture permeability matters in pharmaceutical packaging: Moisture ingress through packaging is a leading cause of chemical and physical instability—especially for hygroscopic APIs, effervescent tablets, and biologics. Even seemingly sealed containers may allow water vapor transmission over time. In stability studies, ignoring packaging permeability can result in underestimated degradation risks and falsely…
Read More “Evaluate Moisture Permeability of Packaging in Stability Testing” »
SOP for Applying ICH Guidelines to Stability Testing for Radiopharmaceuticals Guidelines for Stability Testing of Radiopharmaceuticals as per ICH Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing of radiopharmaceuticals in accordance with the ICH guidelines. This SOP ensures that stability data supports the quality,…
Read More “SOP for Applying ICH Guidelines to Stability Testing for Radiopharmaceuticals” »
SOP for Implementing Stability Testing for Cell Therapy Products under ICH Q5A Guidelines for Stability Testing of Cell Therapy Products as per ICH Q5A 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for cell therapy products in accordance with the ICH Q5A guidelines. This SOP…
Read More “SOP for Implementing Stability Testing for Cell Therapy Products under ICH Q5A” »
SOP for Conducting Stability Testing for Gene Therapy Products as per FDA Guidelines Guidelines for Stability Testing of Gene Therapy Products as per FDA Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for conducting stability testing for gene therapy products in accordance with US FDA requirements. This SOP…
Read More “SOP for Conducting Stability Testing for Gene Therapy Products as per FDA Guidelines” »
Don’t leave empty-handed. Watch practical GMP scenarios, inspection lessons, deviations, CAPA thinking, and real compliance insights on our YouTube channel. One click now can save you hours later.