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 93

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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FDA Dosage Documentation Compounding 107

ISPE

SEPTEMBER 13, 2023

Meet the 2023 Foya Supply Chain and Social Impact Categories Winner: SERUM Institute of India Pvt. Logan Thomas Wed, 09/13/2023 - 11:09 iSpeak Blog iSpeak Meet the 2023 Foya Supply Chain and Social Impact Categories Winner: SERUM Institute of India Pvt.

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Vaccines 98

ISPE

JULY 26, 2023

As the world strives to emerge from the grip of the pandemic and restore activities reminiscent of pre-pandemic times, uncertainties surrounding supply chain stability persist. These include optimizing supply chain operations, lifecycle management, lab transformation, sustainable development, and navigating emerging markets.

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Pharmaceutical Companies Pharmaceutical Companies 52

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 114

ISPE

MARCH 28, 2023

With multiple geopolitical and pandemic related challenges in recent years, having a robust supply chain has increasingly become a strategic advantage for the pharmaceutical industry. The pharmaceutical supply chain runs through the entire process of new drugs from innovation to clinical to approval.

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Adverse Reactions Packaging Communication Labelling 52

ISPE

MARCH 28, 2023

2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit.

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Adverse Reactions Packaging Communication Labelling 52

The Checkup by Singlecare

APRIL 12, 2024

The short supply of this Type 2 diabetes drug has been the subject of many headlines and social media posts. For patients impacted by this issue, it’s important to understand current supply and demand and learn how to prepare for any future Ozempic shortage. Looking for an Ozempic shortage update? You’re not alone.

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Pharmacy Program Director Labelling FDA Hospitals 105

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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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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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 FDA Vaccines 106

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 80

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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Documentation Labelling FDA 109

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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The 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.

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Compounding FDA Communication 59

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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FDA 122

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.

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Pharmaceutical Companies Pharmaceutical Companies 80

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.

Vaccines 107

Vaccines 107

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 117

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.

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Documentation 98

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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FDA Compounding 89

DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. pharmaceutical industry is wrapped up in a web of regulations, and one of the most significant in recent years is the Drug Supply Chain Security Act (DSCSA).

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Independent Pharmacies Packaging Documentation FDA 52

ISPE

JULY 28, 2023

I realized that my network within ISPE was very much focussed on Aseptic, Manufacturing, and Quality, and not so much on Digitalization and Pharma 4.0™. This field is evolving rapidly, and by using the tools of quality risk management and contamination control strategy, we see big advancements. I hope to see you there in person!

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ISPE

JULY 28, 2023

I realized that my network within ISPE was very much focussed on Aseptic, Manufacturing, and Quality, and not so much on Digitalization and Pharma 4.0™. This field is evolving rapidly, and by using the tools of quality risk management and contamination control strategy, we see big advancements. I hope to see you there in person!

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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.

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FDA Pharmaceutical Companies Pharmaceutical Companies 95

Hospital Pharmacy Europe

OCTOBER 30, 2023

With any medicines bought outside of the legal supply chain, the contents may not match the ingredients on the label.‘ Products purchased in this way do not meet our strict quality and safety standards, and taking such medicines may put your health at significant risk. ‘We

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Labelling Packaging Hospitals 52

ISPE

JUNE 23, 2023

Kulkarni, PhD 23 June 2023 The 2023 ISPE Annual Meeting & Expo features Manufacturing, Quality Control, and Operational Excellence as one of the key content areas. Accelerating Drug Development Pharmaceutical companies are always looking to bring new drugs and equipment faster to the market and gain a higher supply chain agility.

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Pharmaceutical Companies Pharmaceutical Companies 94

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.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 116

European Pharmaceutical Review

JANUARY 16, 2023

Interpharma, Switzerland’s research-based pharmaceutical industry association stated the agreement “…will strengthen the resilience of supply chains and therefore improve the security of supply.”. Economics and risks of FDA’s Quality management maturity rating programme.

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FDA 112

Pharmaceutical Technology

JULY 19, 2022

ESG needs to be at the core of any healthcare company or institution that wants to continue to provide quality care and services. ESG: Covid-19 and the Ukraine crisis has led to a greater focus on supply chains. As a result, medicine and medical supply shortages were a frequent occurrence.

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Hospitals Vaccines 64

ISPE

NOVEMBER 1, 2022

2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. 2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. Quality and Stability. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”.

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FDA Insurance Chemotherapy Documentation 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.

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Communication Dosage Chemotherapy Documentation 84

The People's Pharmacy

MARCH 30, 2023

A New Report on Drug Shortages: The hand wringing about our inadequate medicine supply chain has been going on for a very long time. Parents may have noticed that children’s fever-reducing medicines were in short supply last month. The report to the Senate notes that the drug supply chain is opaque.

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FDA Hospitals Patient Care 74

ISPE

SEPTEMBER 8, 2022

Many of these requirements include adhering to global regulatory harmonization, improving supply chain robustness, minimizing drug shortages, reducing the complexity of managing product life cycles, and reducing the environmental impact of pharmaceutical processes. It also enables a robust product supply. Amanat Kaur.

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Packaging FDA 93

ISPE

SEPTEMBER 7, 2023

Advanced Technology to deliver medicines faster, cheaper, and with enhanced quality. Beyond the technical complexities, the risk averse industry is facing other obstacles while shifting to new technologies. supply chain management, pharmaceutical quality system, and so on). The combination of the two above.

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Hospitals Pharmaceutical Companies Pharmaceutical Companies 98

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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European Pharmaceutical Review

NOVEMBER 16, 2023

Single-use bioprocessing is advantageous due to the reduced contamination risk, flexibility and shorter turnaround times, and its requirement for less energy than stainless steel systems, due to not needing cleaning or sterilisation between batches, the report highlighted. Could centrifugal bioreactor accelerate cell-therapy manufacturing?

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