This article series intendeds to remove some of the mystery surrounding the topic and to provide readers a broad background on data management and data integrity — as well as suggestions for how they might begin to address this issue within their company.
AstraZeneca is a global, science-led biopharmaceutical business. They are one of a handful of companies to span the entire life cycle of a medicine – from research and development to manufacturing and supply – as well as the global commercialization of primary care and specialty care medicines. Operating in more than 100 countries, AstraZeneca employs around 57,500 people worldwide. The company has manufacturing operations in 17 countries, and their innovative medicines are used by millions of patients worldwide.
It doesn't happen often. In over a decade Vaisala Canada's Quality Manager has seen it only once, but calibration certificates are sometimes counterfeited.
Recently a QA manager in a pharmaceutical company asked our Regulatory Compliance Experts about how to create a Validation Master Plan. In this article we outline the guidance in US and EU, and offer links to references that can help you build and improve your VMP.
In our application notes and articles about environmental management in pharmaceutical, biotechnology, and medical device applications we usually stay at the level of principles because every scenario is different. Guidance documents are written broadly for just this reason: the needs of each product and the parameters of each environment will, more than all other factors, determine how you will apply regulations and guidance.
Along with providing monitoring and validation systems, we often delve into issues that arise for our customers when they are interpreting regulations and guidance. We receive many questions on 21 CFR Part 11 and Annex 11. In this article we we offer some background and a brief overview of three focal points of both of the "Elevens" including: System Controls, Validation and Archiving.
Three years into a U.S. initiative for drug “serialization,” companies are: (a) working with the FDA; (b) taking their own steps to traceability; and/or (c) hoping the day of reckoning fades further into the future. But the future is here with serialization reaching into the consumer’s home.
A report on biologics API outsourcing provides insights on how marketing and reputation influences BioPharma's selection of CMOs. Both sides need to line up actual CMO performance and capabilities with market perceptions. But sponsors beware: Under a marketing spell, it appears the best strategy to select CMOs is to find those perceived as most expensive.
UPS' Pain in the Chain survey is one of the best ways to understand where life science companies stand on the issues making logistics a headache and keeping executives up at night. Since 2008, the survey of healthcare and life science supply chain professionals has attempted to determine the needs of these companies.
Last we left off, M. (Ken) Kengatharan, PhD, MBA, serial start-up entrepreneur and scientist – or biotech mixologist – was mixing examples of outsourcing that included falsely inflated balloons and Super Hero deliveries of API. Here Kengatharan draws some final lessons and insights into successful outsourcing.
M. (Ken) Kengatharan is an accomplished mixologist. What he mixes professionally is biotech business models, drug researchers and developers, private and venture capital, entrepreneurs and investors … with a large shot of strategic outsourcing. Through his experiences at the five biotechs he’s put together, we can learn how to improve sponsor and service-provider dynamics.
Eastern Europe was just, you know, after the Wall came down, it was very chaotic, no infrastructure, lack of English-speaking people, you know, all these things that you need to conduct a good business. But, it has been a very exciting and interesting area for the pharmaceutical industry to carry out clinical trials because of the health system which was pretty professional, a large number of patients.
CCIT system for flexible pouches using mass extraction technology.
James Marcino: “I would say, innovations in the specialty market… geo-tracking, so traditionally we’re monitoring temperature results, but there are new devices available now where we can not only monitor the temperature results but also location, humidity, light sensoring.
Ideal for automated testing of microbial load and growth characteristics, GreenLight® 930 microbial detection system offers on-demand sample loading, internal incubation and included software. Benefits include reduced preparation and testing errors, small surface footprint and a maximum test throughput of over 400 tests.
Using proprietary optical technology, the IMD-A microbial detection system is capable of simultaneously detecting both size and intrinsic fluorescence of airborne particulates – screening for biologic particles as small as 0.5 microns.
Fast Lyophilisation on the Genevac Series 3 HT Evaporator was developed to provide a rapid, high-throughput alternative to freeze drying HPLC purification fractions.
Micromeritics manufactures a broad line of automated analytical laboratory instruments that measure the physical characteristics of powders and solids for fundamental research, product development, quality assurance and control, production, and process control applications.
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and their industry. Founded in 1980, today ISPE serves 23,000 members in 90 countries.
Model N is the pioneer and leading provider of Revenue Management solutions for the Life Sciences and Technology industries. Our solutions enable our customers to maximize revenue and reduce revenue compliance risk by transforming their revenue life cycle from a series of tactical, disjointed operations into a strategic, end-to-end process.
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