Group items tagged

In the pharmaceutical industry, maintaining strict hygiene standards is paramount to ensure the safety and efficacy of products. One of the critical components in achieving this goal is the utilization of sanitary clamps. These clamps play a vital role in securing various connections within pharmaceutical equipment, preventing contamination, and upholding sterile conditions. In this article, we delve into the reasons why sanitary clamps are indispensable for maintaining hygiene in pharmaceutical settings. Contamination Prevention Sanitary clamps serve as a crucial barrier against contamination in pharmaceutical environments. With stringent regulations governing pharmaceutical manufacturing, any compromise in hygiene can result in significant consequences, including product recalls and compromised patient safety. Sanitary clamps are designed to create secure and airtight connections between pipes, hoses, and other components, effectively sealing off potential entry points for contaminants such as bacteria, viruses, and particulate matter. By minimizing the risk of contamination, these clamps help pharmaceutical companies uphold the integrity of their products and adhere to regulatory standards. Moreover, the design of sanitary clamps ensures ease of cleaning and sterilization, further reducing the risk of cross-contamination between batches. Unlike traditional fastening methods that may harbor bacteria or residue, sanitary clamps feature smooth surfaces and minimal crevices, making them easier to sanitize. This not only enhances hygiene but also promotes efficiency in the cleaning process, allowing pharmaceutical manufacturers to maintain high levels of cleanliness without compromising production timelines. Overall, by preventing contamination and facilitating thorough cleaning, sanitary clamps play a crucial role in safeguarding the quality and safety of pharmaceutical products.

Your gut, often referred to as your "second brain," plays a crucial role in your overall health and well-being. From digestion to immunity, mood regulation to nutrient absorption, the gut impacts various aspects of our daily lives. With increasing awareness of the gut-brain connection, prioritizing gut health has become a cornerstone of holistic wellness. In this article, we explore effective strategies to support and nurture your gut, empowering you to enhance your quality of life through simple yet impactful practices. Nourish with Probiotic-Rich Foods The gut microbiome, comprised of trillions of bacteria, fungi, and other microorganisms, is a dynamic ecosystem essential for digestive health and immune function. To maintain a healthy balance of gut flora, incorporating probiotic-rich foods into your diet is paramount. Yogurt, kefir, kimchi, sauerkraut, and kombucha are excellent sources of beneficial bacteria that promote gut diversity and resilience. These fermented foods not only replenish your gut with probiotics but also provide essential nutrients and enzymes vital for optimal digestion. By regularly including probiotic foods in your meals, you can foster a thriving gut microbiome, fortifying your body's natural defenses against pathogens and inflammation.

Two Indian pharmaceutical companies, Cipla and Glenmark, are pulling back certain products from the American market due to manufacturing concerns, according to the US Food and Drug Administration (USFDA). A New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution due to "short fill", news agency PTI reported, quoting the latest Enforcement Report issued by the US health regulator. Produced at the company's Indore SEZ plant, this medication is used to manage symptoms associated with lung diseases, such as asthma, chronic bronchitis and emphysema. Cipla USA decided to recall the affected lot following complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, the USFDA said, adding that the drug maker initiated the Class II recall in the US market on March 26 this year.

American pharmaceutical giant Pfizer has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its medication Etrasimod, marketed as Velsipity, used to treat people with moderately to severely active ulcerative colitis. Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers (sores) in the lining of the large intestine (colon) and rectum. The approved recommended dose for Velsipity is one 2 mg tablet to be taken once daily. For the first three days, it is advised to take the medication with food, and subsequently, it can be taken daily either with or without food. According to the regulator, the approval of the medication is based on evidence from two clinical studies, which showed that 26 per cent of patients taking etrasimod achieved clinical remission after 12 weeks of treatment compared with 11 per cent of those receiving placebo. The studies included more than 740 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the public to exercise caution when buying anti-choking devices online, ensuring these products are purchased from reputable sellers. As estimated by the regulator, more than 10,000 counterfeit or unbranded anti-choking devices have been purchased by the public within the last two years through listings on online marketplaces such as Amazon and eBay, as well as drop-shipping websites. People are cautioned that the use of such products poses a substantial risk of failure in clearing blockages and could exacerbate the situation by pushing obstructions further down into the airway passage. Dr Alison Cave, MHRA Chief Safety Officer, said: "Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK's regulatory requirements. "These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents."

The UK government has decided to ban disposable vapes to tackle the rise in youth vaping and protect children's health, Prime Minister Rishi Sunak announced on Sunday (28 January 2024) during a visit to a school. Official figures revealed that the number of children using vapes has tripled in the past three years, with nine per cent of 11 - to 15-year-olds now affected by this rising trend. Disposable vapes are believed to be mainly driving the worrisome rise in youth vaping, with the number of 11- to 17-year-old vapers using disposables estimated to have increased by almost ninefold in the last two years. Sunak said: "As any parent or teacher knows, one of the most worrying trends at the moment is the rise in vaping among children, and so we must act before it becomes endemic. "The long-term impacts of vaping are unknown and the nicotine within them can be highly addictive, so while vaping can be a useful tool to help smokers quit, marketing vapes to children is not acceptable."

Global healthcare company Mundipharma and Vectura, an inhalation contract development and manufacturing organization, have entered into a collaboration agreement aimed at reformulating an asthma inhaler as part of their commitment to reducing the product's carbon footprint. The companies will be working together on incorporating an environmentally friendly propellant into the formulation of flutiform, a pressurised metered-dose inhaler (pMDI) used for asthma treatment, to achieve a near-zero-emissions product. Currently, the product uses the approved apaflurane hydrofluoroalkane 227 (HFA-227), a type of fluorinated greenhouse gas, as its propellant. The European Union's regulation on these types of greenhouse gases targets a two-thirds reduction in their usage and subsequent emissions by 2030. In a joint statement, companies revealed that work is already in progress to find an alternative to the HFA-227 gas. Yuri Martina, Chief Development and Medical Officer at Mundipharma, said: "This is the first step in our long-term plan to develop a near-zero-emissions asthma inhaler.

Eli Lilly's weight-loss medicine Mounjaro, also known as tirzepatide, will be available in the UK within weeks as a four-dose pre-filled injection pen. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug to treat adults with type 2 diabetes and for weight management in obese patients. Branded as Mounjaro KwikPen, the injection is to be used together with a reduced-calorie diet and increased physical activity, the regulator said. "The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on people's health, is clear. "This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month's treatment, of one dose per week," said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.

The World Health Organization (WHO) issued a warning on Thursday regarding falsified semaglutide medications used for treating type 2 diabetes and obesity in select countries. This WHO Medical Product Alert addresses three falsified batches of the specific brand Ozempic that were detected in Brazil (October 2023), the United Kingdom and Northern Ireland (October 2023), and the United States (December 2023). These falsified semaglutide products were distributed through the regulated supply chain. Novo Nordisk, the genuine manufacturer of Ozempic, confirmed that the three products mentioned in the alert are falsified and were not produced by the company. Healthcare professionals, regulatory authorities and the public are advised to remain vigilant regarding these falsified batches of medicines. Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, urged stakeholders to stop any usage of suspicious medicines and report them to relevant authorities.

The World Health Organization (WHO) reiterated its concerns about tobacco companies' continued targeting of young people through various channels such as social media, sports, and music festivals, as well as the introduction of flavored products. In a joint report with industry watchdog STOP released on Thursday, the WHO accused these companies of attempting to ensnare a new generation in nicotine addiction. While facing stricter regulations on traditional cigarettes, major tobacco firms and newcomers have turned to alternatives like vapes, arguing they are intended for adult smokers. However, the WHO and STOP highlighted in their report that these products often appeal to youth, with their attractive designs and fruity flavors making them more appealing to children than to adults in many countries.

In the pharmaceutical industry, maintaining high standards for water quality is crucial for ensuring product safety, efficacy, and compliance with regulatory standards. Water is a fundamental ingredient in drug manufacturing, and its quality directly impacts the production process and the end products. This makes adherence to water service compliance a legal obligation and a critical aspect of operational integrity. THE LEGAL COMPLICATIONS OF POOR WATER QUALITY Compliance with water quality standards in the pharmaceutical industry is mandated by regulatory agencies such as the MHRA, several regulations that set strict criteria for the types of water used, including purified water, water for injection, and sterile water. Failure to meet these standards can result in severe penalties, including product recalls, fines, and loss of manufacturing licenses. Regulatory compliance ensures the pharmaceutical companies adhere to legislations and avoid legal repercussions that can damage their reputation and financial standing

The era of modernization has dawned in and we are surrounded by work pressure, deadlines and other kind of life problems. Vitamins are necessary to boost your immune system and regulate your metabolism rate. You can get rid of various ailments and prevent yourself from disorders with the regular of vitamins.

The Pharmacist's Defence Association (PDA) has raised concerns over the adoption of Digital Clinical Excellence (DiCE) guidelines for online prescribing of GLP-1 receptor agonists for weight management in adults. This follows a clash with expert recommendations commissioned by the General Pharmaceutical Council (GPhC) as the PDA "believes the final guidance conflicts with the expert opinion underpins the GPhC's prosecution strategy towards pharmacist prescribers under investigation." In a recent statement, the PDA highlighted the discrepancy between DiCE's guidance and the expert report employed by the GPhC to prosecute pharmacist prescribers using a questionnaire-based consultation model. This conflict has prompted the PDA to withhold its endorsement of the DiCE guidance as it differs from an expert report commissioned by the GPhC. The PDA's reservations stem from the inherent risks associated with questionnaire-based prescribing.