Blog on Environmental Monitoring - Blog de Monitorización Ambiental.

Our blog on Environmental Monitoring in the pharmaceutical industry during 2021

We can’t think of a better way to mark the end of the year on our blog on Environmental Monitoring in the pharmaceutical industry than to highlight some of the content published in the course of 2021.

SherpaPharma is a reliable and effective global solution for Environmental Monitoring, designed to help pharmaceutical companies improve their processes by reducing risks in decision making. This is why our specialists have taken advantage of our blog to offer relevant information to colleagues in the sector who read us.

Interview with Laia Movilla, Product Specialist at Sherpapharma

In this interview, Laia Movilla, Product Specialist at SherpaPharma, outlined how SherpaPharma can optimise the time spent by professionals working in clean rooms and laboratories.

Laia is responsible for defining the requirements of the system, validating the quality of new developments and providing customer support.

Why is Environmental Monitoring important? - ¿Por qué es importante la Monitorización Ambiental?

Santi Tintoré, CEO of Tiselab, wrote a magnificent article on Why Environmental Monitoring is important. Santi emphasised the importance of maintaining the sterility of a product and reducing the risks associated with contamination. This can be achieved with a good, effective Environmental Monitoring program that provides critical information about the manufacturing environment, thereby avoiding the release of a potentially contaminated product.

Validación sistema cloud - Cloud system validation

Laia Movilla and Mercè Anguera, both of whom are Product Specialists at SherpaPharma, contributed to an excellent article about the process of Validating a cloud system in a regulated environment.

In regulated pharmaceutical environments, computer systems, including cloud systems, must comply with 21 CFR Part 11 and EU cGMP Annex 11.

SherpaPharma is fully validated in accordance with these regulations, as well as with guidelines such as US FDA Guidance for Industry Quality SystemsUS FDA Guidance for Industry Process ValidationUS FDA General Principles of Software ValidationUS FDA Guidance for Industry Part 11 Scope and ApplicationPICS/S Annex 11 and GAMP5.

Vincenzo Giorgini

We also had the honour of interviewing Vincenzo Giorgini, director of the Processes and Laboratories Division at Rigel Lifescience. When we spoke to him, Vincenzo stressed the importance that the quality department of the laboratory or production room attaches to significantly reducing the number of manual processes and errors caused by manual data transfer, as well as to printing immediate reports to be linked to batch records with all the data related to each batch of product.

Vincenzo told us that microbiology laboratory technicians and managers appreciate SherpaPharma on account of the time they can save in the acquisition, registration and evaluation of microbiological data.

Solución en la nube para la industria farmacéutica

Michael Delgado, CTO of SherpaPharma, brought all his expertise to this post about the Advantages of a cloud solution for the pharmaceutical industry. Point by point, he described why these online environments offer the same guarantees demanded by the pharmaceutical sector, and they even have some advantages that an on-premise solution cannot provide.

Webinar AB

 

Finally, this year we are pleased to share a video on our blog on Environmental Monitoring in the pharmaceutical industry. This is the video of the webinar entitled Improving your Environmental Monitoring processes. It was led by Dr. Tim Sandle, Pharmaceutical Microbiologist at BPL Ltd., who talked about the risk for environmental monitoring from the point of view of sample selection and data trend analysis, and by Enric Adserà, SherpaPharma Project Manager, who presented the case study of B. Braun, a leading company that has introduced the SherpaPharma Environmental Monitoring solution into its production centres.

Thank you for following our blog on Environmental Monitoring in the pharmaceutical industry. We are delighted that you are reading our articles. We look forward to seeing you in 2022 with more articles of interest!

Happy New Year!


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Sherpa Team