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Pharmaceutical Manufacturing and Packing Sourcer
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The term 'cleaning validation' has been known to make grown men cry, or at least shake with fear! It is a much misunderstood process yet can be relatively straightforward if tackled correctly and methodically. Cleaning validation can be defined as 'documented evidence that has a high level of assurance, where a cleaning process will consistently produce equipment and products meeting pre-determined quality specifications.' There are many approaches to establishing a rugged, documented, validated cleaning programme. Here we will discuss just one option of approaching cleaning validation in a systematic way, to achieve the final cleaning goal.
Step 1
In this initial step, there are four tasks to accomplish before being able to move to Step 2.
1. Identify and keep a record of all manufacturing and filling equipment, which is dedicated to one product or used for multiple products. Equipment used for multiple products may be considered (provided it is qualified) for product grouping as an alternative to individually validating all the products processed with the same equipment. Similarly constructed equipment is defined as having a different size, but built with the same material of construction when compared to the equipment train in the specific group.
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News and Press Releases |
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CPI to showcase results from BioStreamline project developing novel biotherapeutics
CPI, a UK-based technology innovation centre and a founding member of
the High Value Manufacturing Catapult, announced today that it will host
an event in Darlington, UK on 26 June 2019 to disseminate the results
of the £11.2M BioStreamline project to optimise the development of novel
therapeutics. During the event, the project partners — Lonza Biologics,
UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon),
Alcyomics Ltd and CPI — will showcase the results and discuss the
potential impact on overcoming some of the most significant shortcomings
of the biologics supply chain.
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White Papers |
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Investigator Portals: Facilitating and Streamlining Communication & Collaboration with Study Sites
ArisGlobal
ArisGlobal LLC
Investigator site personnel are often frustrated with the lack of transparency and communication with their sponsors, leading to significant dissatisfaction and withdrawal from current and future studies. The adoption of investigator portals gives sponsors a platform that fosters collaboration and improves site management. Learn about five key areas of sponsor-investigator site interactions deserving of electronic communication and collaboration. Technology and design aspects are also covered.
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Industry Events |
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CPhI & P-MEC India
26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India
As the pharma industry looks increasingly towards India for high quality,
low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies
wanting to pick up on the latest trends and innovations the market has to
offer. At CPhI & P-MEC India, you will meet the movers and shakers from
India's pharma machinery, technology and ingredients industries, giving you a
competitive advantage that will help grow your business.
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