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The Pharmaceutical Industry: organisation and competences After our introduction to how the pharmaceutical industry works, today we will be delving a bit further into how it is organized and the competences of the various departments these…
New PLD proposals for medical devices The product liability directive for medical devices was a law that was created in 1985 in the name of Product Liability Directive (PLD) for all types of medical devices /…
How does the pharmaceutical industry work? Pharma has always provided an endless source of health benefits. Two key landmarks shaped the history of humankind: purifying water and developing medication. We owe this second milestone to the…
Process Control Engineer in Automation Area – Batch recipe In the pharmaceutical industry, the use of customized software for process control is the best way to guarantee the quality and integrity of drugs on a large scale. There are…
Product Carryover Limit and Active Substance (API) Worst Case based on HBEL in Cleaning Validation Introduction Pharmaceutical company is in a dramatically revolutionary time in its history. There have been many new, and for this highly conservative industry, radical movements over the past few years…
Pharmacovigilance: an important concept nowadays As the global COVID-19 pandemic unfolded, its rapid spread and often severe manifestations put both the public health profession and the general population at an unprecedented state of alert. While…
Sustainability Within Development and Project Management What is Sustainability? Currently, the global paradigm of business, portraits a scenario where companies tend to focus excessively on the profits and the return of investment generated by the development…
Stability studies to determine/validate the expiration date of drugs Stability studies are one of the main factors when assessing the safety, efficacy and quality of drugs for human use. It is through stability studies that the shelf life of…
Quality Control in the Pharmaceutical Industry Before consuming any type of medicine, they need to be tested and approved for consumption in prepared pharmaceutical laboratories, so that they can be sold and consumed by the population.…
The role of Validation in the Pharmaceutical Industry What is Validation? In a very general definition, validation can be described as the documented evidence that a system or process is compliant and so it can replicate consistent results,…
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