Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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Compounding Chemotherapy Pharmaceutical Companies Pharmaceutical Companies 40

DiversifyRx

APRIL 4, 2024

Help your patients access the hottest weight loss medications with these semaglutide and tirzepatide resources for independent pharmacy owners, whether you compound or not. I gathered all the helpful resources so independent pharmacies everywhere can help patients get the medications they need to achieve their weight loss goals.

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Independent Pharmacies Compounding Compounding Pharmacies FDA 52

ISPE

MAY 22, 2023

A preview was given of the new ISPE Drug Shortages Prevention Model in which drug shortage prevention focus areas such as quality and manufacturing, regulatory and technology, and innovation align with ISPE’s Communities of Practice and other resources.

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Communication FDA 98

ISPE

MARCH 6, 2023

Sustainability Definitions for the Pharmaceutical Industry Trudy Patterson Mon, 03/06/2023 - 10:26 Features March / April 2023 Sustainability Definitions for the Pharmaceutical Industry William G. Green Manufacturing for the Pharmaceutical Industry.” while meeting patient needs as a primary goal. 1 European Commission.

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Communication Patient Care 52

The People's Pharmacy

APRIL 17, 2023

When someone orders from a “Canadian” pharmacy, the brand-name pharmaceuticals may come from New Zealand, Australia, the UK, Turkey or Mauritius. This online resource can be found under the Health eGuides tab. The growing number of API manufacturing sites in China and other countries suggests the U.S.’ Was it hard or easy?

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Pharmaceutical Technology

AUGUST 10, 2022

Companies should request evidence that the provider can deliver on time, within budget, and that they have the resources and expertise to successfully meet set project milestones.??. Any product sensitives, API configuration, time out of refrigeration (TOR) limits??? appeared first on Pharmaceutical Technology.

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Packaging Communication 52

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Nursing Homes Department of Veterans Affairs FDA Dosage 82

ISPE

AUGUST 16, 2023

These activities are undertaken in close collaboration with national regulators throughout Europe and regulators in third countries. There have been many successes to date, including harmonization of standards on inspections through MRAs along with reduced duplication of effort and more efficient use of resources,” he said. “In

Communication 52

Communication FDA Vaccines 52

ISPE

MAY 9, 2023

Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence Trudy Patterson Tue, 05/09/2023 - 09:34 Features May / June 2023 Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence Scott Fotheringham, PhD 1 May 2023 North Carolina’s Research Triangle is the largest of its kind in the US.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

ISPE

SEPTEMBER 10, 2023

Connor Dennis, PhD Roger Nosal 1 September 2023 As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. WHO Expert Committee on Specifications for Pharmaceutical Preparations.” Watson, PhD Melinda Imperati S.

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Documentation Process Improvement Packaging Pharmaceutical Companies 98

ISPE

JANUARY 11, 2023

Therefore, understanding and designing an effective cleaning process through laboratory testing, field trials, equipment designed for cleanability review, and risk assessments is critical to reducing resources and costs associated with cleaning validation and monitoring activities at the facility. Journal of GXP Compliance 16, no.

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Method Validation Documentation Packaging Compounding 52

ISPE

MARCH 8, 2023

9 , 15 This has led to compounding pharmacies completing high-volume activities such as mass repackaging, thereby increasing the risk of cross-contamination. Pharmaceutical Compounding: A History, Regulatory Overview, and Systematic Review of Compounding Errors.” million vials, 26 had to be recalled and destroyed. Outbreak of B.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

ISPE

MARCH 6, 2023

Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. Sixth Assessment Report: Climate Change 2021: The Physical Science Basis.” Finalized 9 August 2021. C global warming scenario.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

AUGUST 30, 2022

The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines contain information regarding regulatory requirements for raw materials.

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Documentation FDA Packaging Communication 52

ISPE

NOVEMBER 10, 2022

Pharmaceutical Engineering® recently spoke with Kawamata about his work. The quality and availability of data from paper is not sufficient for use in real-time process control and improvement, so we are missing opportunities to finetune our production for the running batch and to better orchestrate downstream activities.

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Documentation Compounding Hospitals Immunization 98

European Pharmaceutical Review

SEPTEMBER 16, 2022

Since the developed regions of the world started to get COVID-19 under control, focus on this matter has only grown – particularly in the pharmaceutical sector, which played a critical role in curbing the devastation caused by the pandemic. But how will this drive for resilience shape the future of pharmaceutical supply chains?

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Packaging Documentation 92

European Pharmaceutical Review

OCTOBER 31, 2022

Ensuring that small and emerging pharmaceutical companies have access to expertise and resources is especially important. 2 However, smaller companies may have limited in-house resources and lack the capabilities to solve the challenges to meet important milestones during early-stage development.

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Compounding Pharmaceutical Companies Pharmaceutical Companies FDA 110

European Pharmaceutical Review

OCTOBER 2, 2023

Eligible companies classified as start-ups and active in the pharma, biopharma, digital, or medical device sectors can exhibit. API Development & Innovation 3. The second panel will be presented by Camille Dumont, Lonza Capsules and Health Ingredients, Juan Colberg, Pfizer, and Sven Stegemann, Leibniz JointLab.

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Packaging 102

ISPE

OCTOBER 27, 2022

C sponsors currently address numerous emerging pharmaceutical entities, as well as manufacturing platforms, modes, and scale. Although there are many advances in cell isolation, activation, transduction, and expansion technologies, currently popular autologous approaches demand a significant footprint for the manufacturing facility.

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Packaging Communication Immunization Vaccines 52

pharmaphorum

MAY 6, 2022

Sanofi has completed the spin-out of its pharma ingredients business EuroAPI, with shares in the new company rising more than 3% on its starting price of €12 in early trading on the Euronext exchange this morning in a declining market. The post Sanofi ingredients spin-out EuroAPI rises on market debut appeared first on.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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Packaging FDA Pharmaceutical Companies Pharmaceutical Companies 105