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Mark Mulvahill, MBA, MSc, discusses the importance of microbial preservation and reference materials in pharmaceuticalmanufacturing and compounding pharmacies, highlighting their role in contamination control, regulatory compliance, and enhancing microbiological testing reliability.
Robert Barrie June 24, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Compounded GLP-1RA medication has become a key revenue driver for Hims & Hers’ telehealth platform. Hims & Hers’ revenue has been soaring on the back of its compounded glucagon-like peptide-1 receptor agonist (GLP-1RA) sales.
FDA: The FDA provided recommended AIs for over 260 NDSRIs based on predicted carcinogenic potency categorization and four NDSRIs based on compound-specific data or read-across analysis from a surrogate and recommended interim AI limits for two NDSRIs, N-nitroso-duloxetine (600 ng/day) and N-nitroso-ciprofloxacin (12,000 ng/day).
The study used medications labelled as “sterile, oral and topical preparations, components of formulations for micro-pellicle media, re-agents, and chemical compounds for achieving selectivity, factors promoting multiplication, and inhibition factors.” aeruginosa bacteria in pure culture, mixed culture, or other research materials.
Processes in pharmaceuticalmanufacturing such as processing, milling, grinding, and mixing, are associated with the generation of dust. The compounds used in the pharmaceutical production are exposed to a wide variety of stresses. Thus, formulation dust containing HPAPIs is a major problem concerning potential exposure.
2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceuticalmanufacturing. Defossilization of pharmaceuticalmanufacturing.
Bacterial spores are a significant concern for aseptic pharmaceuticalmanufacturers due to their ubiquitous nature and intrinsic resistance to environmental stressors such as heat, as well as chemical and radiation inactivating strategies.
These compounds have the potential for addressing a spectrum of neuropsychiatric disorders that currently lack adequate treatment options. As well as advancing DT-101, the new capital injection will also support the progression of two gamma-aminobutyric acid type A (GABA A ) receptor modulators towards clinical trials in 2026.
Compounding the situation to understand how such an outcome was allowed to occur is the fact that many deals between government and pharmaceutical companies selling the treatments and vaccines were agreed under terms of confidentiality. The discussions over the treaty are set to continue for some time.
The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.
While focuses on evaluating and establishing supplier reliability for pharmaceuticalmanufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients.
” Laser marking solution company Datalase has developed a system where an inactive compound can be added to the tablet formulation. ” LEVEL TRACKING Pharmaceuticalmanufacturing company Seidenader Vision has also developed a system – the SATrack and Trace.
The Advanced Technologies Lab will help industry and regulators accelerate the adoption of new technologies that help to mitigate supply chain risks and, where appropriate, establish guidance that supports regulatory predictability, process efficiencies, and faster time to market, all of which can strengthen domestic manufacturing capabilities.
Quality is everyone’s responsibility, and it should pervade every aspect of pharmaceuticalmanufacture and packaging. Quality should not be tested into products; instead, it must be built in at each step of manufacture. Pharmaceuticalmanufacturers must integrate the key functions of the quality control process.
The validation plan applies to all existing and new drug compounds and registered drug products or active pharmaceutical ingredients (APIs) for clinical use or sale. The validation master plan in the pharmaceutical industry must provide evidence that the following major changes comply with regulatory expectations.
Certain laboratory reagents are categorized as dangerous commodities, including but not limited to explosives and gases, combustible compounds, peroxides and oxidizing agents, infectious substances and poisons, radioactive materials, and corrosives. Reagents should only be used for the purposes for which they were designed.
Excipients are essential to the stability, bioavailability, and efficacy of active pharmaceutical ingredients (APIs) and the global excipients market is expected to grow at a compound annual growth rate (CAGR) of 6 to 7 per cent.
Pathways of pharmaceutical pollution Pharmaceuticals enter the environment through several main routes, each exacerbating the growing issue of contamination in our water, soil, and air.
New England Compounding Centre (USA, 2012) One of the deadliest failures in aseptic manufacturing, this incident involved fungal contamination in injectable steroids, leading to over 100 deaths and more than 750 cases of fungal meningitis across the United States. FDA oversight.
The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceuticalmanufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems.
Sometimes, pharmaceuticalmanufacturers employ surface profilometry to assess the roughness of stainless-steel equipment. Ammonium Compounds: Quaternary ammonium compounds, such as Benzalkonium chloride, act as disinfectants and surfactants. Protease, amylase, or lipase enzymes). if used on pre-cleaned surfaces.
This is not the only attempt to revive research into antibiotics: last year more than 20 big pharma companies joined to create the AMR Action Fund , where they joined forces with philanthropists, development banks and other organisations to find new compounds.
Although less commonly discussed, pharmaceuticalcompounds can also become airborne. This can occur through the evaporation of volatile substances or the incineration of pharmaceutical waste, potentially affecting air quality and contributing to broader environmental pollution.
Effective Control of Microorganisms in PharmaceuticalManufacturingPharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST The control of microorganisms in pharmaceutical production ensures that they stay at acceptable levels. Hence, spores require complex treatment to remove them.
For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies. It is basically an essential copy, and the pharmaceuticalmanufacturer has to show bioequivalence to the reference product,” Soefje said. “If
This involves close coordination with specialty pharmacies, infusion services, retail pharmacies, pharmaceuticalmanufacturers, medication access programs, and industry representatives. In many cases, the pharmacist resolves the issue independently, escalating to the provider only when necessary.
The manufacturer must perform test B “Limit of Diethylene Glycol and Ethylene Glycol” to check whether DEG and EG content is no more than 0.10 % prior to use, and not use it if the level is higher than 0.10 %. Regulatory agencies in different countries can use the U.S.
Sectors such as research, testing, medical labs and pharmaceuticalmanufacturing expanded greatly during the pandemic, due to high demand for COVID-19 therapeutics. To date, 747 novel compounds are in production. Since 2018, employment numbers in the industry have grown by 11 percent, totalling $2.9 trillion dollars in 2021.
1 In pharmaceuticalmanufacturing, the high level of final product quality is the major driver. Tablets should be defect-free and compliant to good manufacturing practice (GMP) aspects and final-user requirements. In tablet compression, there are a range of factors which contribute to a successful production run.
Sometimes, pharmaceuticalmanufacturers employ surface profilometry to assess the roughness of stainless-steel equipment. Ammonium Compounds: Quaternary ammonium compounds, such as Benzalkonium chloride, act as disinfectants and surfactants. Protease, amylase, or lipase enzymes). if used on pre-cleaned surfaces.
The practice of calling a piece of equipment clean just because it looks clean is not acceptable in the pharmaceuticalmanufacturing process. Why is cleaning validation required? Equipment that is used for processing medicines is one of the top sources of contamination if not cleaned effectively using a validated cleaning procedure.
In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceuticalmanufacturing. What you will need are properly validated equipment cleaning procedures and a well-defined cleaning and verification regime in order to make sure your products are free from unnecessary contaminants.
Pharmaceuticalmanufacturing operations typically maintain equipment varying from simple balances and scales to complex automated process control and monitoring systems. – Gas Chromatography (GC) Systems (Critical for analyzing volatile compounds). When is equipment qualification necessary?
In addition to standards for active pharmaceutical ingredients, USP also develops standards for the inactive ingredients (excipients) and other raw materials used in drug manufacturing. In a 2019 report on drug shortages, the FDA found that 62% of drug shortages occur because of quality issues in manufacturing.
4 ,5 Millions of Americans rely on medicines that are manufactured outside the United States, particularly from close and longstanding allies such as Ireland, Switzerland, and the United Kingdomcountries whose regulatory frameworks for pharmaceuticalmanufacturing mirror the high standards enforced domestically.
5 The Most Significant Driver of Health Care Spend Isn’t Drugs—It Isn’t Even Close Pharmaceuticalmanufacturers are a frequent punching bag for politicians, mostly because they are easy targets, and they tend to have more visible out-of-pocket exposure.
3,4 How this pricing model will be implemented and whether pharmaceuticalmanufacturers will be able to meet the expectations of the 2025 executive order, if upheld, is uncertain. The order states that if manufacturers are unable to meet the 30-day deadline, the secretary of the Department of Health and Human Services, Robert F.
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