Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications
December 10th 2024This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.
Determining Low PPB Levels of Nitrite in Polymeric Excipients
September 9th 2024In this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.
The Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical Manufacturing
August 11th 2024The growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.
Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products
This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch Release
February 3rd 2024This article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.
Pooling of Batches for Stability Data Analysis
November 3rd 2023One of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability.
In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance
July 3rd 2023FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.
Total Analytical Error in Validation of Analytical Procedures of Pharmaceuticals
May 2nd 2023This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors.
Supplementary Handwashing Techniques to Improve Hand Hygiene
February 3rd 2023A fluorescence test method was used to visually evaluate handwashing efficacy. Difficult-to-clean areas on skin such as skin folds and webbing between fingers were identified; specific washing techniques to address problem areas are proposed.
The Value of Primary Working Standards in Pharmaceutical Quality Control
September 3rd 2022It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.
A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing Process
Researchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.
Grouping Products and Equipment for a Worst-Case Cleaning Validation Study
August 3rd 2021A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.
Comparing Methods for Determining Out-of-Trend Stability Test Results
April 3rd 2021This article describes in detail how simulation was used to compare the statistical techniques used to determine out-of-trend (OOT), which is crucial to avoiding out-of-specification (OOS) events for drug substances and products.