European Pharmaceutical Review

FEBRUARY 9, 2023

Processes in pharmaceutical manufacturing 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.

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European Pharmaceutical Review

DECEMBER 21, 2022

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 pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.

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European Pharmaceutical Review

JULY 5, 2022

Bacterial spores are a significant concern for aseptic pharmaceutical manufacturers due to their ubiquitous nature and intrinsic resistance to environmental stressors such as heat, as well as chemical and radiation inactivating strategies.

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Pharmaceutical Technology

JUNE 19, 2025

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.

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pharmaphorum

DECEMBER 16, 2022

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.

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pharmaphorum

AUGUST 24, 2020

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.

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Quality Matters

AUGUST 3, 2023

While focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients.

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Pharmaceutical Technology

MAY 11, 2008

” Laser marking solution company Datalase has developed a system where an inactive compound can be added to the tablet formulation. ” LEVEL TRACKING Pharmaceutical manufacturing company Seidenader Vision has also developed a system – the SATrack and Trace.

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GMPSOP

OCTOBER 28, 2023

Quality is everyone’s responsibility, and it should pervade every aspect of pharmaceutical manufacture and packaging. Quality should not be tested into products; instead, it must be built in at each step of manufacture. Pharmaceutical manufacturers must integrate the key functions of the quality control process.

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Pharmacy Times

JUNE 4, 2025

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.

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GMPSOP

MAY 31, 2024

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.

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GMPSOP

JUNE 9, 2024

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.

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Express Pharma

NOVEMBER 28, 2024

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.

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Express Pharma

DECEMBER 13, 2024

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.

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Express Pharma

JUNE 20, 2025

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.

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pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems.

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GMPSOP

FEBRUARY 28, 2024

Sometimes, pharmaceutical manufacturers 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.

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pharmaphorum

MARCH 29, 2021

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.

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Express Pharma

JUNE 5, 2024

Although less commonly discussed, pharmaceutical compounds 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.

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Pharmacy Times

JUNE 23, 2025

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 pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said. “If

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GMPSOP

JUNE 15, 2025

Effective Control of Microorganisms in Pharmaceutical Manufacturing Pharmaceuticals 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.

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Pharmacy Times

JUNE 8, 2025

This involves close coordination with specialty pharmacies, infusion services, retail pharmacies, pharmaceutical manufacturers, medication access programs, and industry representatives. In many cases, the pharmacist resolves the issue independently, escalating to the provider only when necessary.

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European Pharmaceutical Review

OCTOBER 27, 2022

Sectors such as research, testing, medical labs and pharmaceutical manufacturing 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.

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European Pharmaceutical Review

OCTOBER 23, 2023

1 In pharmaceutical manufacturing, 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.

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Quality Matters

SEPTEMBER 15, 2023

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.

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GMPSOP

MAY 17, 2024

Sometimes, pharmaceutical manufacturers 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.

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GMPSOP

SEPTEMBER 27, 2023

The practice of calling a piece of equipment clean just because it looks clean is not acceptable in the pharmaceutical manufacturing 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.

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GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. 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.

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GMPSOP

JULY 31, 2023

Pharmaceutical manufacturing 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?

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Quality Matters

OCTOBER 13, 2021

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.

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Putting Patients First Blog

MAY 6, 2025

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 pharmaceutical manufacturing mirror the high standards enforced domestically.

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Pharmacy Times

JUNE 12, 2025

5 The Most Significant Driver of Health Care Spend Isn’t Drugs—It Isn’t Even Close Pharmaceutical manufacturers are a frequent punching bag for politicians, mostly because they are easy targets, and they tend to have more visible out-of-pocket exposure.

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Pharmacy Times

JUNE 16, 2025

3,4 How this pricing model will be implemented and whether pharmaceutical manufacturers 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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