In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”
The short tips in this white paper are intended as a guide to selecting tools which will help you to save valuable time in the eight-phase model of the value creation process.
The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API manufacture.
Companies that utilize chemicals in their labs and their manufacturing processes must manage those chemicals in a safe environment in accordance with government regulations. At a minimum, to ensure that this is accomplished, a system for managing information about the chemical safety and inventory data should be established and maintained. Best practices, on the other hand, take this minimum and leverage the management of the chemical inventory by taking full advantage of the people, processes, and technology involved. This white paper delves into the best practices involved in managing chemical inventory to achieve the most effective, holistic chemical inventory system.
Today’s biotech and pharmaceutical production facilities must drive faster times to market and greater profitability for new products by boosting production yields and accelerating commercialization and scaling of capacity.
A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.
One tool holds a unique position among R&D informatics systems -- electronic laboratory notebooks (ELNs). ELNs both produce data and consume information and are particularly powerful.
“Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.
Laboratories can now rely on Thermo Fisher Scientific’s expanded line of cold-storage products to help them meet their goals for both productivity and sustainability. The company recently earned the U.S. Environmental Protection Agency’s (EPA’s) ENERGY STAR certification for its Thermo Scientific TSX Series ultra-low temperature freezers, which is designed to reduce energy consumption while ensuring sample protection.