Author: digi

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

Include Back-Up Samples for Retesting in Stability Protocols

Understanding the Tip: Why back-up samples are essential in stability studies: Stability testing is a long-term process involving multiple data points over months or years. If a test result is out-of-specification (OOS), out-of-trend (OOT), or suspect due to technical error, having a pre-preserved back-up sample enables immediate retesting without compromising the study timeline. These samples…

Stability Study Tips

Common Errors in Defining Shelf Life and Retest Periods

Defining shelf life and re-test periods is fundamental in pharmaceutical quality systems. Despite clear guidance from ICH, WHO, and national authorities, companies often struggle with proper classification, documentation, and justification. These errors can result in product recalls, audit findings, or even regulatory sanctions. In this tutorial, we walk you through the most common mistakes seen…

Re-Test Period vs. Shelf Life in Pharmaceuticals, Shelf Life and Expiry

Justifying Re-Test Periods with Stability Data

Re-test periods form a critical part of pharmaceutical quality systems, particularly for APIs and intermediates. These durations define the timeframe during which materials remain within specification when stored under defined conditions. However, assigning a re-test period without scientific backing can lead to non-compliance, quality failures, or regulatory citations. In this tutorial, we’ll explore how to…

Re-Test Period vs. Shelf Life in Pharmaceuticals, Shelf Life and Expiry

SOP Template for UV Light Meter Calibration in GMP Facilities

In pharmaceutical GMP environments, maintaining a validated and traceable process for UV light meter calibration is critical for ensuring compliance with photostability testing guidelines such as ICH Q1B. An SOP (Standard Operating Procedure) tailored for UV meter calibration is essential for demonstrating data integrity, equipment traceability, and readiness for inspections by regulatory bodies such as…

Equipment and Calibration

How Re-Test Period Impacts Inventory and Supply Chain Management

The re-test period of a pharmaceutical ingredient isn’t just a regulatory requirement — it plays a vital role in managing inventory, procurement, and the efficiency of the pharmaceutical supply chain. When managed effectively, re-test periods help reduce waste, prevent stockouts, and ensure product quality. When overlooked, they can cause expired stock, delayed shipments, or even…

Re-Test Period vs. Shelf Life in Pharmaceuticals, Shelf Life and Expiry

Involve Regulatory Affairs Early When Designing Stability Studies

Understanding the Tip: Why Regulatory input is essential at the study design stage: Stability studies are critical to product approval, and their outcomes feed directly into global submissions. Involving Regulatory Affairs (RA) early ensures that your study protocol meets the specific expectations of each target market. RA professionals interpret region-specific guidelines and submission formats (e.g.,…

Stability Study Tips

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