Whether because of unfamiliarity or lack of resources, master service or supply agreement (MSA) execution can be time consuming and difficult. At any given pharma…
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Today, ASTM standard E2500, Specification, Design, and Verification of Pharmaceutical and Bio-pharmaceutical Manufacturing Systems and Equipment,1 elevates risk-based validation as a critical aspect of GMP manufacturing, based…
One of the most intriguing experiences we have had in our business in the last 20 years is being faced with a seemingly simple water-soluble…
General Principles (2.1) The design and execution of formal stability studies should follow the principles outlined in the parent guidance. The purpose of a stability…
ICH Q7 expects dedicated production areas for highly sensitizing materials such as penicillins and cephalosporins because of the patient risk (e.g., anaphylactic shock to penicillin-allergic…
Instead of comparing barrier systems solely in terms of investment costs, energy consumption offers another insightful approach – especially as it is in line with…
Although pharmaceutical manufacturers take stringent steps to ensure that their production systems are as safe as possible, a fully gowned operator can still create as…
Manufacturing tablets to a uniform hardness, weight, and thickness requires tablet press punches of consistent length. We will describe how to understand punch length, how…
Water and wastewater treatment applications encompass a wide range of processes, technologies, and physical/chemical methods. Among them, filtration and separation technologies are the core of…
Currently, biopharmaceutical companies are striving to produce biologics more efficiently, with a lower cost point and fewer people. Most small-scale media and buffer operations are…