Author: digi

How to Address Stability Testing for Products under Emergency Use Authorization (EUA)

How to Address Stability Testing for Products under Emergency Use Authorization (EUA) Stability Testing for Products under EUA: Navigating Regulatory Requirements Introduction Emergency Use Authorization (EUA) allows for the use of medical products during public health emergencies, even when they have not completed the standard approval process. Stability testing for products under EUA is crucial…

'How to' - Stability Studies

Storage Conditions Log Template

Storage Conditions Log Template Log of Storage Conditions for Pharmaceutical Products This template provides a record of the environmental storage conditions under which pharmaceutical products are stored. It helps ensure that conditions such as temperature and humidity are maintained within acceptable ranges to preserve product stability. Date Time Temperature (°C) Humidity (%) Recorded By Remarks…

Stability Documentation

SOP for Performing Real-Time Stability Testing for Drug Substances

SOP for Performing Real-Time Stability Testing for Drug Substances Standard Procedure for Conducting Real-Time Stability Testing on Drug Substances 1) Purpose The purpose of this SOP is to provide a structured procedure for conducting real-time stability testing of drug substances to ensure their safety, efficacy, and quality throughout their shelf life under recommended storage conditions….

Stability Studies SOP

How to Implement Stability Testing for High-Risk Drug Products under Regulatory Guidelines

How to Implement Stability Testing for High-Risk Drug Products under Regulatory Guidelines Stability Testing for High-Risk Drug Products: Regulatory Compliance Guide Introduction High-risk drug products, such as controlled substances, cytotoxic agents, and biologics, require stringent stability testing to ensure their safety, efficacy, and quality. Regulatory authorities, including the US FDA, EMA, and WHO, have established…

'How to' - Stability Studies

Labelling Details Log Template

Labelling Details Log Template Log of Labelling Details for Pharmaceutical Products This template tracks and documents all labeling details associated with pharmaceutical products, ensuring proper labeling in compliance with regulatory standards for product identification, batch number, and storage instructions. Date Label Type Product Name Batch Number Storage Instructions Labeling Personnel DD/MM/YYYY [Label Type] [Product Name]…

Stability Documentation

How to Conduct Stability Studies for Drugs with Narrow Therapeutic Index under US FDA Guidelines

How to Conduct Stability Studies for Drugs with Narrow Therapeutic Index under US FDA Guidelines Stability Studies for Drugs with Narrow Therapeutic Index: A Guide to US FDA Compliance Introduction Drugs with a narrow therapeutic index (NTI) have a small margin between therapeutic and toxic doses, making precise and rigorous stability testing essential to ensure…

'How to' - Stability Studies

How to Implement Stability Testing for Non-Oral Dosage Forms in Compliance with Regulatory Guidelines

How to Implement Stability Testing for Non-Oral Dosage Forms in Compliance with Regulatory Guidelines Ensuring Compliance in Stability Testing for Non-Oral Dosage Forms Introduction Non-oral dosage forms, such as injectables, inhalers, transdermal patches, and ophthalmic solutions, present unique challenges in stability testing due to their distinct formulations, delivery mechanisms, and storage conditions. Ensuring compliance with…

'How to' - Stability Studies

Packaging Details Log Template

Packaging Details Log Template Log of Packaging Details for Stability Samples This template records detailed information about the packaging of stability samples in pharmaceutical processes. It ensures traceability and proper documentation of materials, methods, and conditions used during packaging. Parameter Details Packaging Date DD/MM/YYYY Batch Number [Batch Number] Packaging Materials [List of packaging materials used]…

Stability Documentation

SOP for Designing a Stability Study Protocol for Drug Products

SOP for Designing a Stability Study Protocol for Drug Products Procedure for Creating a Stability Study Protocol for Drug Products 1) Purpose The purpose of this SOP is to outline the standardized procedure for designing a stability study protocol for drug products. The aim is to ensure that all stability studies are conducted consistently and…

Stability Studies SOP

How to Conduct Stability Testing for Biologics Under Biosimilar Regulatory Guidelines

How to Conduct Stability Testing for Biologics Under Biosimilar Regulatory Guidelines Stability Testing for Biologics: Adhering to Biosimilar Guidelines Introduction Biologics, including biosimilars, are complex molecules that require stringent stability testing to ensure their safety, efficacy, and quality. Stability studies for biosimilars must demonstrate that the product remains comparable to its reference biologic under specified…

'How to' - Stability Studies