PharmTech
Nov 1, 2024 · Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development, and manufacturing.
Best Practices for Designing and Building a Pharmaceutical ...
Feb 2, 2021 · Additionally, oversight by drug sponsor leaders who possess the appropriate expertise and dedicated bandwidth to focus on the project is extraordinarily valuable.
The Basics of Aseptic Processing - PharmTech
Oct 2, 2021 · Additionally, the article explores the rational for not employing PUPSIT because of the concern “that the contamination/product deterioration risk associated with performing PUPSIT may greatly outweigh the risk of product contamination as a result of the masking effect.
Pharmaceutical Technology - PharmTech
The Real Message Behind Commercial mRNA Products, April 2023 eBook
Understanding USP Water for Pharmaceutical Use - PharmTech
May 1, 2017 · Manufacturing of pharmaceutical products, medical devices, biologics, cell- and tissue-based products, and many other medical products requires significant volumes of water.
Classifying Potent and Highly Potent Molecules - PharmTech
Aug 1, 2018 · Highly potent drugs represent a growing proportion of medicines, including therapies in development and those commercially available. As older products reach patent expiry, generic-drug companies are also moving into this space, creating an increasing demand for capability and capacity to manufacture highly potent APIs (HPAPIs), particularly for contract manufacturing organizations (CMOs).
Verifying Compendial Methods - PharmTech
Apr 2, 2022 · Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.
Deviation Investigation Format and Content: A Guide for
Jul 2, 2017 · History review. The history review section is intended to provide the reader with an overarching historical context of the deviation event. This section typically includes a query of the quality management system with specific words and phrases pertaining to the current deviation event with the goal of identifying similar and/or related events.
The Fundamentals of Dissolution Testing - PharmTech
Oct 2, 2019 · Defined dissolution apparatus and development of new tools. Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.Of the seven apparatus, basket type (apparatus I) and paddle type (apparatus II) are most ...
The ICH Q9 Revision and a Renewed Focus on Quality Risk
Dec 2, 2023 · The new revision of ICH Q9 was timely, as the pharmaceutical industry had spent many years since the original version was published in 2005 trying to establish the look and feel of effective QRM while also struggling with QRM processes that became increasingly resource hungry and complex.