European Pharmaceutical Review

MARCH 8, 2024

Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. Therefore, to achieve this, quality by design offers a systematic approach to development, the authors stated.

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83

Outsourcing Pharma

SEPTEMBER 27, 2021

The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.

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52

Outsourcing Pharma

JANUARY 26, 2022

A leader from the RBQM solutions specialists offers a preview of his SCOPE 2022 presentation on tools suited to decentralized trial design and management.

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52

BioPharm

MAY 8, 2023

The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality.

Documentation 52

Documentation 52

Pharmacy Times

AUGUST 31, 2023

After 1 year of treatment, semaglutide significantly improved physical function, which can improve quality of life outcomes and risk of death.

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123

Fierce Healthcare

OCTOBER 9, 2023

Boulder Care, a telehealth provider for substance use disorder, has met all of its performance quality measures in a value-based payment arrangement with a managed Medicaid insurer in Oregon. | Boulder agreed to put a portion of its reimbursement for medical services at risk until quality performance metrics were achieved.

Insurance 114

Insurance 114

Outsourcing Pharma

SEPTEMBER 27, 2021

The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.

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ISPE

JULY 21, 2023

The first keynote presentation, “Smart Missions that Enable Innovation in High-risk Environments,” was delivered by Dr. Ed Hoffman, a senior lecturer at Columbia University who retired from NASA as a Senior Executive. Aerospace is healthier today at NASA and SpaceX by balancing risk and innovation.

Documentation 98

Documentation 98

Outsourcing Pharma

NOVEMBER 21, 2023

CluePoints, a company providing risk-based study execution (RBx) and risk-based quality management (RBQM) software for clinical trials has won the best Contract Research Organization (CRO) in the specialist providers category at Citelineâs 2023 SCRIP Awards.

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Outsourcing Pharma

MAY 10, 2022

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.

FDA 52

FDA 52

Outsourcing Pharma

AUGUST 4, 2023

Risk-based quality management (RBQM) is used to identify and assess risks then finding ways to manage them and is an important part of clincal trials.

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European Pharmaceutical Review

APRIL 10, 2024

A novel routine nuclease testing regimen developed to ensure resilience against nuclease contamination can be utilised as part a laboratory’s quality management system (QMS), a paper reports. The regimen may be applied as a quality indicator fulfilling certain ISO quality control criteria, and offers “documented, systematic feedback”.

Documentation 73

Documentation 73

European Pharmaceutical Review

APRIL 18, 2024

When measuring active pharmaceutical ingredient (API) concentrations in effluents, the limit of quantification (LoQ) of the chosen analytical method must be sensitive enough to measure anticipated effluent concentrations or risk-derived targets at the sampling point. Another important consideration is the sampling point.

Pharmaceutical Companies 77

Pharmaceutical Companies Pharmaceutical Companies 77

European Pharmaceutical Review

JANUARY 2, 2024

A paper published in the European Journal of Pharmaceutics and Biopharmaceutics has reviewed the current application status of Quality by Design (QbD) within the framework of the ICH guidelines (ICH Q8(R2) – Q14 and ICH Q2(R2)). It also lowers the regulatory burden too, the paper reported. [In For example, Simões et al.

Documentation 96

Documentation 96

Pharmacy Times

OCTOBER 14, 2022

Investigators found that lifestyle changes such as a high-quality diet and regular exercise can lower the risk of type 2 diabetes in women with a history of gestational diabetes mellitus.

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123

Pharmacy Times

AUGUST 26, 2022

Risk factors associated with declining health-related quality of life for adult survivors of childhood cancer, such as physical inactivity and chronic health conditions, should be targets of surveillance and intervention.

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123

European Pharmaceutical Review

JANUARY 29, 2024

9 Reflecting on five years of quality control for nitrosamine impurities ICH M7(R2) 10 indicates that, “Higher acceptable intakes may be justified when human exposure to the impurity will be much greater from other sources, eg, food or endogenous metabolism (eg, formaldehyde)”. Thus, NDSRIs could be generated endogenously.

FDA 97

FDA Vaccines Compounding 97

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. So what might that look like? Embracing the spirit rather than the letter of regulations. Process (and portfolio) optimisation.

Documentation 111

Documentation Vaccines 111

PQA

DECEMBER 27, 2023

PQA has published more than 80 blogs this year, providing insights and updates on our work to improve medication use quality. As these new indications drive new patterns of use, it is important to understand how medications used to treat diabetes or weight loss affect quality measures focused on diabetes medication. In the U.S.,

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52

Fierce Healthcare

SEPTEMBER 28, 2023

Reveleer, a health tech company focused on value-based care, has unveiled two new suites of solutions for risk-bearing providers. | The Prospective Risk Adjustment and Quality Improvement product suites are designed to ease providers’ administrative burden and deliver timely clinical insights at the point of care.

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The Checkup by Singlecare

OCTOBER 16, 2023

| Physical benefits | Mental health | Productivity | Improve sleep quality | The bottom line For many, the best part of the day is getting into bed for a good night’s sleep. Getting enough sleep, in terms of quantity and quality, is important for the body. Getting enough quality sleep helps the immune system.

Immunization 98

Immunization Vaccines 98

European Pharmaceutical Review

JULY 4, 2023

However, critical disciplines within the field responsible for ensuring safe and effective drug products, including quality assurance and compliance, remain mysterious or invisible to many. Quality assurance and compliance-related plans are affected by supply chain issues.

Communication 81

Communication Dosage Chemotherapy Documentation 81

The FDA Law Blog

NOVEMBER 29, 2023

Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks. Five guiding principles were identified for PCCPs and relate to being focused, risk-based, evidence-based, transparent, and taking into consideration total product lifecycle management.

FDA 115

FDA Labelling Communication 115

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.

FDA 122

FDA 122

European Pharmaceutical Review

JULY 8, 2022

As established facilities age, various risk considerations emerge. In an article published in the Journal of Validation Technology (JVT), pharmaceutical microbiologist and contamination control expert Tim Sandle identified ten categories of risk presented by aging.

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122

OctariusRx

SEPTEMBER 18, 2023

There are many factors that impact our risk of falls, but it’s important to remember that falling is NOT a normal part of aging. According to the NCOA, falls not only increase the likelihood of patient injury, but they also take a heavy toll on quality of life. Most falls are caused by a combination of risk factors.

Nursing Homes 74

Nursing Homes 74

The Checkup by Singlecare

APRIL 14, 2024

Gabapentin for sleep | When to take gabapentin for sleep | Dosage | Risks | Alternatives Getting enough sleep is one of the most important ways to support your health. Sleep quality is also critical, and transitioning smoothly through sleep cycles is essential to having high-quality sleep to wake up feeling rested.

Dosage 97

Dosage Labelling FDA 97

European Pharmaceutical Review

FEBRUARY 22, 2023

Therefore, contamination control measures are tailored to the specific risks around each individual process. Dr Madina Karimova, Quality Assurance Manager at Sanofi shared her opinion on PDA’s TR 90 report, highlighting parts she found valuable.

Documentation 88

Documentation 88

European Pharmaceutical Review

NOVEMBER 9, 2023

Issue 5 of European Pharmaceutical Review features articles on manufacturing, development and quality control of biopharmaceuticals from antibodies to mRNA and cell and gene therapies. We also explore opportunities for outsourcing of regulatory activities, the challenges of paediatric drug formulation and much more.

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81

European Pharmaceutical Review

AUGUST 3, 2023

With the corrective and preventive action (CAPA) process often a “one-size-fits-all” approach, a whitepaper by the Medical Device Innovation Consortium (MDIC) Case for Quality Collaborative Community (CfQcc) has instead shared a risk-based framework focusing on continuous improvement.

Documentation 52

Documentation Process Improvement FDA 52

Pharmacy Times

MAY 5, 2023

difficile infection (CDI), its risk factors, symptoms, and quality of life for the patient. Joseph Reilly, BS, PharmD, BCGP; Candace Cotto, RN; and Andrew Skinner, MD, review C.

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65

European Pharmaceutical Review

JULY 24, 2023

Proficiency testing programmes aim to increase the product analysis and knowledge to contribute to overall improvement in drug product quality. A paper published in Pharmaceutics has proposed how a personalised preparation quality assurance programme can achieve this when these products are developed in compounding laboratories.

Compounding 68

Compounding Documentation 68

ISPE

MARCH 20, 2023

For data integrity, this situation poses serious risks because interfaces are vital links and play a key role in maintaining data integrity throughout the business processes and across systems. It aims to identify DI-relevant issues and risks to data quality right from the start, at the planning phase.

Documentation 97

Documentation Communication 97

STAT

JULY 20, 2023

Americans who live in neighborhoods with less socioeconomic advantage may have a higher risk of dementia, according to a new study published Wednesday in JAMA Neurology. with the lowest levels of income, education, employment, and housing quality had a 1.17

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ISPE

MARCH 16, 2023

We will also address the ways in which these approaches can help to improve adherence to new Annex 1 and the overall quality and safety of pharmaceutical products. One of the key changes in the latest revision of Annex 1 is a focus on Contamination Control Strategy (CCS) and Quality Risk Management (QRM).

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

The Checkup by Singlecare

JANUARY 9, 2024

The benefits of magnesium are also associated with sleep quality. Teenagers and older adults, especially men, are more at risk for having magnesium deficiency which can affect the sleep cycle. Analyzing the different types of magnesium will provide a better understanding of which is the best form to take for quality sleep.

Dosage 95

Dosage Immunization 95

European Pharmaceutical Review

SEPTEMBER 12, 2023

Second, activities must be based on quality risk management principles, with a strong direction towards proactive assessments and then setting appropriate corrective and preventative action (CAPA). Next, a data-driven approach and scientific principles must be used, along with validated methods and processes.

Documentation 124

Documentation 124