Pharma and Life Sciences Blog

OCTOBER 26, 2023

A Fast-Food Giant Saves €14 million in Fresh Produce Costs With GEP annmarie@AZglo… Thu, 10/26/2023 - 21:00 When a quick-service restaurant (QSR) chain struggled to contain the costs of procuring fresh produce and maintain its quality for its European outlets, it turned to GEP.

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Quality Matters

JUNE 14, 2023

To ensure GDPs and patient safety requires coordination, collaboration, and continuous quality improvement, the panel generally agreed. The panel was titled: “Securing the Downstream Supply Chain: Good Distribution Practices.” FDA and USP in Rockville, Maryland.

Dosage 52

Dosage Packaging Documentation Hospitals 52

European Pharmaceutical Review

NOVEMBER 2, 2023

In 2023, a combination of factors, including increased demand (particularly for critical medicines), economic inflation, as well as international geopolitical unrest, has led to Europe’s supply chain being acutely affected. This included engaging with key players in the supply sector in relation to the key antibiotic amoxicillin.

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Express Pharma

MAY 15, 2024

Artificial Intelligence (AI) is an emerging digital technology-driven tool to support various processes from design and development to distribution and delivery of goods and services with improved quality, safety, security and punctuality, thereby helping to enhance consumer satisfaction and boost the trust-building process.

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Packaging Labelling 83

pharmaphorum

NOVEMBER 27, 2022

Supply chain issues have been rife in pharmaceuticals for a while, but current socio-economic challenges such as the conflict in Ukraine and the COVID-19 pandemic have led to extended wait times and higher prices for thousands of products. This has been the go-to approach for dealing with foreseeable supply chain shocks in the past.

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Communication Pharmaceutical Companies Pharmaceutical Companies Packaging 105

European Pharmaceutical Review

MARCH 27, 2024

Overall, this indicates that the Swedish life sciences industry is strengthening its position as a significant player in the global market, with innovation and high-quality product exports specifically helping to drive global demand, SwedenBIO claimed. We also see that Swedish companies are very connected internationally.

Drug Development 83

Drug Development 83

Quality Matters

JANUARY 4, 2024

Prioritizing Quality Across the Manufacturing Eco-System in India India is often referred to as the ‘pharmacy of the world’ and is an undeniably the leading manufacturing hub for many of the world’s most essential medicines. This visit coincided with the fourth USP South Asia Regional Chapter Meeting held in New Delhi.

Pharmaceutical Manufacturing 69

Pharmaceutical Manufacturing 69

Quality Matters

JANUARY 23, 2023

Omnibus Spending Law: Provisions Will Bolster Medicines Supply Chain Insights and Advanced Manufacturing Technologies Investments to create a more resilient medicines supply chain and prepare for future public health emergencies are among key provisions of the mammoth $1.7

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Generic Medicine Pharmaceutical Manufacturing Biosimilars Communication 52

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

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Documentation Communication 89

pharmaphorum

JULY 28, 2022

Supply chain shortages have dominated headlines for several months, and the pharma industry has been no exception. While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. This exacerbates the supply chain issue.

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Diabetes Dosage Pharmaceutical Manufacturing Documentation 102

Quality Matters

APRIL 20, 2023

Standards support medicines supply chain resilience and the future of quality It is not uncommon for people to sometimes take important things for granted, such as the quality of the medicines they rely on for their health. While not usually top-of-mind, standards and other quality-focused solutions developed by the U.S.

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Biosimilars Labelling Vaccines Generic Medicine 52

Express Pharma

APRIL 2, 2024

To overcome these challenges and achieve sustainable growth, the pharma industry needs to leverage the power of data science and data analytics, which can provide insights, solutions and innovations across the entire value chain. They can help the pharma industry in various ways to improve efficiencies and outcomes.

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Drug Development Clinic Management Communication 59

European Pharmaceutical Review

NOVEMBER 16, 2022

Across all of this is the criticality of compliance with Good Manufacturing and Good Distribution Practice (GMP/GDP) and of a fit-for-purpose quality system. Making quality more integral to production. That is because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.

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Documentation Vaccines Drug Development 111

Quality Matters

MAY 18, 2023

The panel was titled “Manufacturing Solutions to Strengthen Global Supply Chain Resilience.” USP is working to address barriers to AMT adoption through a broad portfolio of quality-focused solutions including standards, analytical laboratory services , and related programs. FDA and USP in Rockville, Maryland.

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Generic Medicine Pharmaceutical Manufacturing 52

Quality Matters

SEPTEMBER 15, 2023

FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Disclaimer: The article below includes a discussion of key points of the guidance document. The systemic root causes of these occurrences stem from limited control of high-risk excipients. Ensuring Product Safety: U.S. polyethylene glycol).

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Documentation Compounding Pharmaceutical Manufacturing 52

Quality Matters

FEBRUARY 22, 2023

Innovative Matrix Framework Assesses Risk for Substandard Antibiotics Substandard medicines are a huge public health threat. Proactively evaluating drug products using a relative risk assessment is important to reduce the prevalence of substandard antibiotics. USP: What are risk assessments?

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Quality Matters

JUNE 21, 2023

The panel was titled “Securing the Downstream Supply Chain: Post-marketing Surveillance.” It helps identify any emerging, potential quality and safety concerns, risks or adverse effects and events, including the potential for SF medical products to enter the supply chain. FDA and USP in Rockville, Maryland.

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Communication Vaccines Documentation 52

Quality Matters

MAY 25, 2023

Impurities in the medicines supply chain: Global cooperation essential to safeguarding patients Continued global cooperation to strengthen supply chain resilience and assure medicines quality was a recurring theme at the Asia-Pacific Economic Cooperation ( APEC ) forum’s Medical Product Supply Chain Dialogue April 25-26, co-hosted by the U.S.

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Communication 52

European Pharmaceutical Review

JANUARY 25, 2023

Regulators, medicine manufacturers and suppliers have been urged by the World Health Organization (WHO) to take action against contaminated medicines in the supply chain. Increase market surveillance including risk-based targeted testing for medical products released in their respective markets including informal markets.

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European Pharmaceutical Review

JUNE 22, 2023

On 6 June 2023, the British Standards Institute (BSI) launched its Minimized Risk of Antimicrobial Resistance (AMR) certification for antibiotic manufacturing. Soulsby and Brooks explain what the new certification means for antibiotic manufacturers and the wider pharma industry, and its anticipated benefit for supply chain sustainability.

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Quality Matters

OCTOBER 10, 2023

Standards on the Frontlines: Responding to public health crises and strengthening supply chains Vulnerabilities or disruptions to the global medicine supply chain (including drug shortages) continue to make headlines. The result—improved quality overall in the world’s global supply of this critical medicine.

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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.

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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 Pharmaceutical Manufacturing Department of Veterans Affairs Dosage 76

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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Generic Medicine Vaccines 100

Quality Matters

APRIL 18, 2024

Pharmacopeia (USP) we recognize that fulfilling our mission to improve public health through quality standards and related programs can also help to address pressing social and environmental challenges. USP standards help ensure that medicines meet quality expectations critical to patient safety and public health.

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Pharmaceutical Manufacturing Packaging Generic Medicine 59

Quality Matters

OCTOBER 24, 2023

Right now, there are at least 15 cancer drugs in shortage, and hundreds of other essential drug products that are in short supply…. Peters also introduced in 2023 the bipartisan “ Mapping America’s Pharmaceutical Supply (MAPS) Act ,” supported by USP, to create a federal database to map the U.S.

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Chemotherapy Hospitals 64

Express Pharma

JANUARY 2, 2024

The letter hopes that this exercise will ‘rule out possible quality issues related to DEG/EG and diversion of industrial grade PG in the pharma industry.’ After a period of denial, the CDSCO started cracking down in December 2022, with a series of risk based inspections.

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Express Pharma

JUNE 2, 2023

This ensures patients receive genuine medications, reducing the risk of ineffective or harmful treatments and protecting their well-being. Quality control and regulatory compliance: Traceability is crucial for maintaining quality control and ensuring compliance with stringent regulations in the medicine space.

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Adverse Reactions Packaging Documentation Dosage 87

FDA Law Blog: Biosimilars

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.

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Compounding Online Pharmacies Communication 59

Quality Matters

AUGUST 10, 2023

Pharmacopeia (USP) embarked on the pilot project in November 2021 with Vietnam’s National Institute of Drug Quality Control (NIDQC) to validate procedures for monitoring nitrosamine impurities in selected sartan drug products. The monitoring program was an opportunity to work with USP’s Preferential Access for Regulators, or PAR, Program.

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Drug Development 52

Quality Matters

DECEMBER 8, 2023

For example, while CPCA is an important tool for evaluating the level of risk posed by NDSRIs, it’s not all-inclusive. Product recalls are also a real risk. There is great focus on quality testing. These activities require high-quality reference materials and robust testing methods.

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European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Figure 1 : adapted from Saha, G. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.

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Pharmaceutical Manufacturing Drug Development 122

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.

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Hospitals Communication 119

Quality Matters

MAY 17, 2023

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

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Drug Development Dosage Pharmaceutical Manufacturing 52

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.

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Vaccines 103

European Pharmaceutical Review

APRIL 15, 2024

external factors such as equipment, seasonality, and the transit of people and supplies between environments can potentially influence the transfer of microorganisms found in cleanrooms” Soares et al. The authors emphasised that regular maintenance was key in maintaining control of bioburden levels.

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European Pharmaceutical Review

JUNE 29, 2023

Quality control testing can help manufacturers in monitoring their processes and reduce the risks of potential formation of those impurities, thus minimising disruptive and costly drug recalls. However, it is difficult to predict exactly how processes could behave and how materials could react under each process conditions.

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Compounding 85