Showing posts with label GAMP. Show all posts
Showing posts with label GAMP. Show all posts

Friday, 23 November 2018

Digital manufacturing in the life sciences industry.

Zenith Technologies recently conducted an industry survey that suggests the digitalisation of manufacturing is a top priority.

The company conducted a survey of business and operational leaders across the life science sector on the trends and technologies that may revolutionise the industry over the coming years.

The research suggested an increasing appetite for Industry 4.0 – which focuses on using data and information to revolutionise GMP manufacturing.

Nearly 60% of those surveyed believe that Industry 4.0 will drive the most change in life science over the next 5 years, with 75% of those aiming to invest in people to take advantage of emerging technologies.

It also uncovered the main motivators for technology investment were cost and time saving, with more than 70 % of respondents citing these reasons.

Following on from these findings, Zenith published a whitepaper ‘Industry 4.0: Revolutionising life science manufacturing through connected systems and data’ written by global services director, David Staunton and MES project manager, Ryan McInerney.

The paper examines technological advances that are driving the next phase of pharmaceutical manufacturing, improving quality and reducing waste.

David Staunton said: “The life science industry has used data and information to drive improvements in GMP Manufacturing for decades and there is now an opportunity to take it to the next level.”
“The foundation of life science GMP manufacturing is to know your process and industry 4.0 allows us to stay true to who we are, while at the same time revolutionising GMP manufacturing.”


@ZT_Global  #PAuto @ramarketingpr

Tuesday, 21 February 2017

GAMP5 complience in pharma industry.

The pharmaceutical industry is subject to strict regulatory requirements which demand a lot of time and effort to be spent documenting every step, process, and item. Itris Automation will be hosting a webinar in March 2017 to demonstrate how PLC Checker can help pharmaceutical companies more efficiently verify and document the GAMP 5 compliance of their PLC programs.

Part of the International Society for Pharmaceutical Engineering (ISPE), Good Automated Manufacturing Practice (GAMP) is a set of guidelines regarding automated systems. These guidelines explain how to incorporate quality into each step of the manufacturing process to achieve the required quality of the finished product. Although not an obligation, most pharmaceutical companies choose to be compliant with GAMP, now recognised worldwide as a good practice. However, ensuring compliance and creating all of the required documentation is a laborious process.

In the webinar, you will discover an innovative way to address Appendix D4, “Management, Development, and Review of Software”, of the GAMP guidelines which will save companies time and money. Using PLC Checker, a unique static analysis tool dedicated to PLC programs, and the GAMP coding rules option, users can quickly and efficiently verify their level of compliance and automatically produce the necessary documentation.

Join the webinar to find out how you can save time and money in your GAMP 5 compliance process.

Karoline Beske, Export Director at Itris Automation, will conduct the first webinar in English on 20th March at 4pm (GMT+1) and a second in German on 27th March at 11am (GMT+1). Both webinars are free of charge and open to anyone. Book here.

@ItrisAutomation #PAuto  #GAMP #Pharma