The Basics of Aseptic Processing - PharmTech
Oct 2, 2021 · Aseptic processing is a manufacturing method that produces sterile products without terminal sterilization. Learn the difference between aseptic and terminal sterilization, the environmental controls and testing required, and the challenges of aseptic drug manufacturing.
PharmTech
Nov 1, 2024 · PharmTech covers the latest trends and innovations in bio/pharmaceutical formulation, development, and manufacturing. Find articles, podcasts, webinars, and events on topics such as fill/finish, formulation, excipients, gene therapy, and more.
Understanding USP Water for Pharmaceutical Use - PharmTech
May 1, 2017 · Learn about the nine types of water defined by USP for different applications in pharmaceutical production, such as injection, infusion, irrigation, and inhalation. Find out the chemical and microbiological requirements, specifications, and …
Pharmaceutical Technology - PharmTech
Browse the online archive of Pharmaceutical Technology, a monthly journal covering the latest trends and innovations in the pharmaceutical industry. Find issues on topics such as formulation, manufacturing, quality, regulation, outsourcing, and more.
Best Practices for Designing and Building a Pharmaceutical ...
Feb 2, 2021 · Learn best practices for drug sponsors who want to build their own factories to bring products to market faster. Find out how to synchronize process and facility design, create a project team, and make facility decisions.
Classifying Potent and Highly Potent Molecules - PharmTech
Aug 1, 2018 · Learn how to determine the occupational exposure limit (OEL) and occupational exposure band (OEB) of potent and highly potent drugs, and how to apply them in manufacturing. The article explains the factors that affect the OEL, the uncertainty factors, and the dose-response curve of toxicity.
Verifying Compendial Methods - PharmTech
Apr 2, 2022 · Learn how to verify the suitability of compendial methods for your product and laboratory conditions. The article explains the difference between validation and verification, and provides guidance on verification criteria and requirements for different types of methods.
Product Annual/Quality Review: US–EU Comparative Analysis and ...
Mar 2, 2008 · Learn the differences and similarities between the US and EU requirements for the annual review of pharmaceutical products and active ingredients. Compare the objectives, frequency, procedure, and scope of the product annual review (PAR) and the product quality review (PQR) according to FDA, EU GMP, and ICH Q7A guidance.
The Fundamentals of Dissolution Testing - PharmTech
Oct 2, 2019 · Learn how dissolution testing is used to characterize, control, and optimize oral solid dosage forms throughout drug development. Explore the types of dissolution apparatus, media, and methods, and the factors that affect dissolution performance and bioavailability.
Deviation Investigation Format and Content: A Guide for
Jul 2, 2017 · The web page does not contain any information related to sispq. It is a guide for writing deviation investigation reports in pharmaceutical manufacturing, with sections on executive summary, background, event description, history review, root cause, product impact, and corrective actions.