Pharma Stability: Insights, Guidelines, and Expertise
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…
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,…
SOP for Conducting Stability Studies for Drugs with Narrow Therapeutic Index under US FDA Guidelines Procedure for Stability Testing of Drugs with Narrow Therapeutic Index 1) Purpose The purpose of this SOP is to define the procedure for conducting stability studies for drugs with a narrow therapeutic index in compliance with US FDA guidelines. This…
Understanding the Tip: Why raw data archiving is critical in stability programs: Stability testing results are only as credible as the raw data supporting them. Chromatograms, instrument readouts, and raw calculation sheets form the foundational evidence for any reported result. Without properly archived original data, final results lose credibility—especially during audits or regulatory reviews. Archiving…
Read More “Archive Raw Data Printouts and Chromatograms in Stability Files” »
SOP for Implementing Stability Testing for Non-Oral Dosage Forms in Compliance with Regulatory Guidelines Procedure for Stability Testing of Non-Oral Dosage Forms 1) Purpose The purpose of this SOP is to establish a procedure for conducting stability testing of non-oral dosage forms (e.g., injectables, topical, inhalation) in compliance with relevant regulatory guidelines. This ensures that…
SOP for Conducting Stability Testing for Biologics Under Biosimilar Regulatory Guidelines Procedure for Stability Testing of Biologics in Compliance with Biosimilar Regulations 1) Purpose The purpose of this SOP is to define the procedures for conducting stability testing of biologics under biosimilar regulatory guidelines. This ensures that biosimilar products meet the required standards of quality,…
SOP for Addressing Stability Testing for Breakthrough Therapy Drugs under FDA Guidelines Procedure for Stability Testing of Breakthrough Therapy Drugs 1) Purpose The purpose of this SOP is to establish a procedure for conducting stability testing of breakthrough therapy drugs in compliance with US FDA guidelines. This ensures that these drugs maintain their intended quality,…
SOP for Implementing ICH Q1A(R2) for Stability Testing of APIs and Drug Products Procedure for Stability Testing According to ICH Q1A(R2) Guidelines 1) Purpose The purpose of this SOP is to define the procedures for implementing the ICH Q1A(R2) guidelines for the stability testing of active pharmaceutical ingredients (APIs) and drug products. This ensures that…
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Understanding the Tip: Why power backup periods pose risk to testing validity: Backup power systems like diesel generators or UPS units are essential for continuity during outages, but they often introduce fluctuations in voltage, current, and equipment cooling. During these periods, stability chambers, refrigerators, analytical instruments, and HVAC systems may operate under compromised control—affecting sample…
Read More “Avoid Stability Testing During Power Backup Periods Due to Unstable Conditions” »
One of the most overlooked but critical challenges in pharmaceutical stability testing is the handling of anonymous changes in databases. Such modifications, if left untracked, pose a serious threat to data integrity and can result in regulatory non-compliance. In this tutorial, we explore how pharmaceutical professionals can identify, prevent, and document unauthorized or anonymous changes…
Read More “Handling Anonymous Changes in Stability Databases” »
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