Cleaning validation is a necessary and time-consuming part of the pharmaceutical manufacturing process. Cleaning validation is a requirement in pharmaceutical production that adheres to Good Manufacturing Practice (GMP) and Quality Systems Regulations (QSR). Simply put, validation is a documented guarantee that cleaning can be performed reliably and repeatedly to achieve a specified level of purity. Validation is achieved by demonstrating at least three times that the cleaning process removes...

Is your internal strategy prepared for uncertainties in the development of biological drugs?

Mar 19, 2020 | Registration Process

The pharmaceutical industry's former dependence on blockbuster drugs has evolved to focus on developing drugs that address the unmet needs of smaller patient populations. These niche drugs are most commonly found in the form of biopharmaceuticals, which have accounted for an ever-increasing share of new drug approvals over the last ten years, from a low of 10 percent to a high of 27 percent.1 By 2022, 50 percent of the top 100 products are expected to come from biopharmaceuticals.2...

Washing your hands properly to reduce the risk of infection

Mar 18, 2020 | Health

Here you can read about how and when to wash your hands to reduce the risk of infection. https://www.infektionsschutz.de/haendewaschen/ https://www.mgc-prevention.fr/operation-mains-propres/

Three factors worsen the health prognosis of COVID-19

Mar 17, 2020 | Health

According to a multivariate regression analysis, the researchers identified three markers associated with an increased risk of mortality, namely: Age, SOFA score, D-dimer concentration. The older you are, the higher the mortality rate (odds ratio 1.10 per year of life). Common concomitant disorders in intensive care patients with organ failure were: Hypertension (48% non-survivors vs. 23% survivors), diabetes mellitus (31% vs. 14%), coronary heart disease, CHD (24% vs. 1%), chronic obstructive...

Rimegepant 75mg orodispersible tablet for migraine treatment

Mar 16, 2020 | Medicines

The US FDA has approved the Rimegepant 75mg orodispersible tablet. The freeze-dried tablet should dissolve almost immediately in the mouth without water and provide a convenient, discreet way to take migraine medication....

Why the Corona Rapid Test is so important

Mar 14, 2020 | Health

A newly developed, fully automated test, which can be performed millions of times, delivers results in only three and a half hours instead of days. Why is broad-based testing so important at this difficult time? Apart from good care, tests are the only instrument against Covid-19 that is currently medically available. https://www.handelszeitung.ch/unternehmen/coronavirus-weshalb-der-test-von-roche-so-wichtig-ist

Ensuring pharmaceutical production even during the COVID-19 crisis

Mar 4, 2020 | Others

Every organisation should prepare its response to incidents based on their business impact, to allocate valuable resources to what poses the greatest threat to ongoing operations. A business stability guideline prepares an organisation to continue operations amidst the myriad of potential business disruptions and aims to achieve a high level of resilience across all departments and locations. A pandemic poses a unique challenge, as its global spread threatens the workforce, as well as the...

DPI, the first nasal glucagon preparation for hypoglycaemia

Mar 2, 2020 | Medicines

Baqsimi has been approved for nasal application in Germany since 01/03/2020. It does not need to be stored in the refrigerator like injectable glucagon. After response to the administered dose, carbohydrates should be administered orally to replenish the hepatic glycogen stores to prevent re-hypoglycaemia. https://www.gelbe-liste.de/diabetologie/baqsimi-diabetes-unterzuckerung

Valproate-containing drugs not suitable for girls and women of childbearing age

Feb 27, 2020 | Medicines

Children who have been exposed to Valproate in the womb are at high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in about 10% of cases). Girls and women should only take Valproate-containing medication if other treatments are not effective or are not tolerated and if a contraceptive programme is followed. https://www.gelbe-liste.de/nachrichten/valproat-informationsbrief

Tramadol increases the risk of a hip fracture

Feb 22, 2020 | Medicines

Tramadol not only increases the risk of falling, but also causes more hip fractures than other painkillers. This is the result of a study published in the Journal of Bone and Mineral Research. According to the study, the risk of hip fractures in the tramadol group is 28% higher than with codeine and even 65% higher than with ibuprofen. https://www.lemoniteurdespharmacies.fr/revues/le-moniteur-des-pharmacies/article/n-3309/le-tramadol-augmente-le-risque-de-fracture-de-la-hanche.html

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