Does not compute: When and how pharmaceutical automation fails

In simple terms, ‘automate’ means to run or operate (something, such as a factory or system) by using machines, computers, etc., instead of people to do the work. Hence, the implementation of automation technologies, techniques and processes improve the efficiency, reliability, and/or speed of many tasks that were previously performed by humans. Expanding upon this concept, ‘what automation is’ in the pharmaceutical process, a simple example is with an automatic control loop. Here a controller compares a measured value of a process with a desired set value and processes the resulting error signal to change some input to the process, in such a way that the process stays at its set point despite disturbances.

 

Hence, workplace automation is a means of combining a series of simple, repetitive tasks to create a straightforward, streamlined flow of operations, without the risk of human error. Utilizing the benefits of automation is one of the essential elements of industry 4.0. Drivers for automation also include economic pressures, such as business disruptions, safety concerns, regulatory requirements, customer service, financial problems, and competition. Each of these triggers at least conditions the pharmaceutical company to consider pursuing workflow automation.

 

 

Reference:

 

Sandle, T. (2021) Does not compute: When and how pharmaceutical automation fails, Pharma Machines and Technology, 15 (6): 18-30

 

Individual article: https://pharmamachines.com/does-not-compute/

 

Full magazine: https://issuu.com/pharma.machines/docs/feb_-_mar_2021?fr=sZmVjNTEyMDg4MjQ

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Clinical Laboratory book

 

The medical laboratory, as a field of activity, involves teamwork. The specialization of Laboratory Medicine is obtained by studying the following medical disciplines: Biochemistry, Microbiology, Hematology, Genetics, Molecular Biology, Biology, Immunology to which is added the study in a series of fields necessary for a complete professional training It includes vast types of combined subdomains.

 

The results of the laboratory work are part of the paraclinical investigations that help establish the diagnosis. This book explores these fields.

 

Chesca, A. and Sandle, T. (2021) Clinical Laboratory, Edizioni Sapienza, Italy ISBN 978-620-3-60359-0

See here (click on image):

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

What To Expect From A Remote Inspection -- & How To Navigate It

 

The 2020–2021 coronavirus pandemic has caused multiple changes across the pharmaceutical and healthcare industries. One such difference has been the move toward remote inspections. To address this new approach, both parties (regulatory inspectors, such as FDA; and inspectees, such as pharmaceutical, biotech, or medical device companies) need to make changes relating to technology and culture. Given that this model will also continue, to an extent, post-coronavirus, it is important that organizations prepare for remote inspections.

 

This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.

 

The general success of the model may lead to remote inspections becoming part of the normal inspection process.

See:

Sandle, T. (2021) What To Expect From A Remote Inspection -- & How To Navigate It, Pharmaceutical Online, 23^rd July 2021, at: https://www.pharmaceuticalonline.com/doc/what-to-expect-from-a-remote-inspection-how-to-navigate-it-0001

 

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)