pharmaphorum

JUNE 22, 2022

The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. Security of supply. The growing importance of the question over supply will likely grow, as the pandemic has raised fears over the supply of medicine.

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Manufacturing Production Drugs Medicine 114

pharmaphorum

JANUARY 20, 2022

According to the company, the defendants reportedly sold 85,247 bottles of medicine with counterfeit Gilead labelling to pharmacies over a two-year period, using falsified supply chain documentation to conceal their origin. This works to ensure the safety and efficacy of the drugs received by patients.

Drugs 111

Drugs Medicine Containment Branding 111

Cloudbyz

OCTOBER 19, 2023

Protocol Adherence: Ensures that the trial adheres to the study protocol, reducing deviations and improving trial quality. Risk Management: Identifies and mitigates risks early in the trial, preventing costly delays. Centralized Monitoring: Provides a centralized dashboard for monitoring site performance and data quality.

Clinical Trials 84

Clinical Trials Clinical Trials Trials Compliance 84

XTalks

NOVEMBER 10, 2020

Despite enhanced safety measures brought on by the COVID-19 pandemic, consumers are still skeptical about the safety, source and quality of the foods they buy, according to a new survey. Growing incidences of product adulteration, food fraud and foodborne illness outbreaks have created a need to re-evaluate supply chains.

Production 105

Production Sales Manufacturing Regulation 105

Pharmaceutical Technology

OCTOBER 26, 2022

Managing drug supply in the midst of unexpected and changing circumstances can be overwhelming. When events such as under or over-enrollment occur or a protocol amendment is made, the ripple effects impact drug supply directly. To avoid this, many trial supply managers will overestimate the production of supplies.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Production 130

pharmaphorum

JANUARY 6, 2021

Indeed, while undoubtedly putting new hurdles in our path, the arrival of COVID-19 into our lives has transformed our business and operations by presenting an opportunity to be adaptable, flexible and responsive – and to continually evaluate and mitigate risk. Why chain of custody and identity is critical.

Manufacturing 119

Manufacturing Production Engineer Genetics 119

FDA Law Blog

JANUARY 22, 2024

Led by former federal prosecutor Jill Furman, OC is charged with shielding consumers “from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions.” Drug Supply Chain. This is important information for every drug maker and its quality teams. Clinical Trials.

Compliance 59

Compliance Clinical Trials Clinical Trials Regulation 59

pharmaphorum

DECEMBER 29, 2022

In times of accelerated process design, pharma companies must drop manual workflows that risk clerical errors and data integrity violations. Digital batch execution management, electronic lab notebooks, and factory dashboards can remove risk from these error-prone processes.

Manufacturing 111

Manufacturing Medicine Pharma Companies Engineer 111

Cloudbyz

MARCH 30, 2023

Standardization: As therapies are personalized, it is challenging to standardize manufacturing processes, which can lead to inconsistencies in therapy quality and efficacy. Additionally, establishing clear quality control measures and ensuring consistent process monitoring can help ensure therapy quality and efficacy.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

pharmaphorum

JULY 21, 2022

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. As a result, some businesses have been forced in the last 18 months to make risk-based decisions based on the resources available to them rather than the quality assurance of a product.

Compliance 98

Compliance Regulation Manufacturing Contamination 98

XTalks

APRIL 16, 2024

This year’s summit promises to be an essential event for anyone involved in food safety and quality assurance. The summit showcases advancements in AI and blockchain technology, providing attendees with knowledge on how these tools can enhance traceability and manage risks in the supply chain.

Regulation 105

Regulation Compliance Allergies Manufacturing 105

The Pharma Data

SEPTEMBER 14, 2020

Supply chain uncertainty is a challenge every clinical supply chain manager wrestles with – stemming from increasing product demand and quality, the growing complexity of clinical trial designs and a lack of visibility in the supply chain.

Clinical Supply Chain 52

Clinical Supply Chain Clinical Supply Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 28, 2022

In addition to having attractive products, ensuring the supply chain of those products is secure is an increasing concern for companies. An exemplary record of regulatory inspections can help give confidence to any potential purchaser that the supply chain is secure. Post-acquisition compliance.

Compliance 119

Compliance Regulation Manufacturing Licensing 119

Pharmaceutical Technology

JUNE 19, 2023

“Cell and gene therapies are not your typical clinical supply chain. It’s much more complex and it has to be 100% correct, or else patients are really at risk,” explains Michael MacNeir, vice president of Business Development, Sharp Clinical. The risk of mistakes caused by improper planning are enormous.

Gene Therapy 130

Gene Therapy Gene Packaging Packaging 130

Pharma Business Blog

MAY 8, 2023

Switzerland has reached a Mutual Recognition Agreement (MRA) with the United States for good manufacturing practice (GMP) inspections, which will facilitate and decrease administrative barriers in the exchange of pharmaceutical products between the two countries which will further strengthen the supply chain.

Manufacturing 52

Manufacturing Life Science Production Drugs 52

Drug Discovery World

JULY 11, 2022

However, the speed at which CGT products can impact healthcare depends on how the industry will navigate novel challenges and risks from the nascent field of CGT development. Storing and managing CGT ancillary supplies and clinical materials requires an inventory management system with various safeguards and risk mitigation protocols.

Gene Therapy 52

Gene Therapy Gene Development Production 52

XTalks

AUGUST 4, 2023

The Trader Joe’s recall situation has garnered significant attention in the past week, as the popular retail chain declared three different product recalls during the last week of July. This variety may increase Trader Joe’s recall risk compared to stores sourcing from large-scale manufacturers.

Production 72

Production Contamination Manufacturing Licensing 72

pharmaphorum

NOVEMBER 2, 2022

The Eden Project’s own Sir Tim Smit discusses ‘Thinking Big: Systemic Change’ and the Environment Agency posits ‘Walking the walk: how do we work together to enable our organisations and supply chains to become truly sustainable?’. Today, DFN questions ‘Are we who we say we are?’,

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ACRP blog

SEPTEMBER 27, 2023

“Today, there are [approximately] 200 clinical trials under way in Phase III targeting patients with rare, complex diseases who often face death, disability, or poor quality of life from lack of effective treatments,” Belazi writes. “As

Clinical Trials 64

Clinical Trials Clinical Trials Trials Gene Therapy 64

Advarra

JUNE 26, 2023

This blog provides key insights and guidance for sponsors and sites as they work to mitigate risks and ensure compliance for a successful FDA inspection. Best Practices to Becoming Inspection Ready Maintaining compliance with the regulations means taking a proactive, risk-based approach to safety, quality, and efficacy.

Compliance 52

Compliance Regulation Marketing Production 52

pharmaphorum

JANUARY 24, 2023

In 2023, pharmaceutical companies must unlearn the old lessons of commercial engagement, where frequency and face-to-face were key, and focus on the quality of meaningful interaction, where a healthcare professional’s attention is fully engaged and the experience is meaningful to their work. Medicines manufacturing is energy intensive.

Medicine 98

Medicine Manufacturing Regulation Marketing 98

XTalks

APRIL 11, 2024

Regular testing is critical, given the health risks associated with lead exposure. These measures are essential for maintaining trust in the food supply and preventing lead exposure, especially among vulnerable populations such as children and pregnant women.

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Contamination Branding Production Containment 59

The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. At the BIO International Convention, Carey Connolly, Ph.D.,

Manufacturing 40

Manufacturing Development Protein Gene Therapy 40

Drug Discovery World

JANUARY 31, 2023

Ideally, it encapsulates every stage of drug development including drug candidate identification, clinical trials establishing efficacy, manufacturing processes, and supply chain activities for delivering these therapies to patients. As the amount and complexity of data increases so do timelines and risks to the filing’s accuracy.

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Manufacturing Production Engineer Development 98

Drug Discovery World

FEBRUARY 28, 2023

We have found it is possible to address the challenges in this unique space through strategic approaches that can accelerate development timelines, minimise risks and reduce costs in getting these medicines to patients. dose adjustments based on subject age/weight) is key.

Development 52

Development Drugs Manufacturing Production 52

XTalks

MARCH 25, 2022

Pfizer has issued voluntary recalls for several lots of its blood pressure medication Accuretic, and two generic versions of it, over concerns of higher than acceptable levels of a nitrosamine called N-nitroso-quinapril, which is associated with an increased risk of cancer.

Contamination 95

Contamination Drugs Production Manufacturing 95

XTalks

AUGUST 21, 2020

Michel Nielen, professor of food safety at Wageningen University & Research, in the Netherlands wanted to create a fundamental change in the world of food monitoring, so he and his team coordinated the FoodSmartphone project which is developing ways to detect food quality and safety using smartphones. But it’s not enough. Traceability.

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Regulation Big Data Contamination Production 110

The Pharma Data

DECEMBER 31, 2020

But I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “This is a very positive step towards ensuring global access to COVID-19 vaccines.

Vaccination 52

Vaccination Vaccine Production Medicine 52

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. They also aim to ensure medical devices created through the use of AI/ML are secure, efficient, and maintain a high level of quality.

Clinical Research 52

Clinical Research Compliance Research Regulation 52

Pharma Packaging Solutions

OCTOBER 6, 2021

Outsourcing pharmaceutical packaging to contract packaging organizations (CPOs) is a cost-effective way for pharmaceutical companies to bring drugs to market without sacrificing packaging quality. Dedicated packaging companies are better equipped to take design risks than in-house pharmaceutical packaging operations.

Packaging 52

Packaging Packaging Pharma Companies Contract Packaging 52

XTalks

DECEMBER 20, 2021

It is stable at 2 to 8 °C refrigerated temperatures, making it easier to store and ship using conventional cold chain supply chains. WHO EULs are based on assessment of the quality, safety and efficacy of vaccines. percent and reduced the risk of progression to moderate-to-severe COVID by 100 precent.

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Vaccination Vaccine Manufacturing Protein 96

Pharmaceutical Technology

NOVEMBER 4, 2022

We want to empower people to think about the things that you can do to reduce their risk of developing any kind of brain changes,” adds McNeil. It means you can quickly get quality information for companies that want to pick out some insights from looking at that data,” explains McNeil. We've looked at multiple sclerosis.

Medicine 130

Medicine Development Research Gene 130

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For instance, CAPA in good manufacturing practices (GMP) addresses manufacturing deviations and quality deficiencies. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable.

Compliance 52

Compliance Clinical Development Development Clinical Trials 52

Roots Analysis

AUGUST 29, 2023

It is important to mention that manufacturing and control of cell therapy products relies heavily on the quality of raw material used during the development process. Therefore, to maintain a consistent supply of products for patients, well-characterized materials from trusted suppliers, combined with robust processes are essential.

Reagent 52

Reagent Manufacturing Production Containment 52

The Pharma Data

JANUARY 13, 2021

Avoid risking the quality of water in manufacturing practice, subsequent product process delays and compliance issues with this handy guidebook. The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Add bookmark.

Compliance 52

Compliance Manufacturing Regulation Contamination 52

The Pharma Data

OCTOBER 23, 2020

Accurate pregnancy dating and quality care combined with the steroids are key to survival. Dexamethasone and similar drugs have long shown to be effective in saving preterm babies lives in high-income countries, where high-quality newborn care is more accessible.

Packaging 52

Packaging Packaging Clinical Trials Clinical Trials 52

pharmaphorum

JULY 19, 2021

That means learning the lessons of the last 18 months, by enhancing supply chain capacity and investing in pandemic preparedness and planning, said the report. In addition, people on ventilators or with weakened immune systems have been at risk of secondary infections, which has further driven up use of antimicrobials.

Clinical Trials 105

Clinical Trials Clinical Trials Medicine Manufacturing 105