European Pharmaceutical Review

OCTOBER 20, 2023

At forty percent, the most popular initiatives currently in use across the industry are: ‘waste and water reduction programmes’.

Process Improvement 109

Process Improvement 109

European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. It provides tools for the process improvements using robotics, which is well-established in other manufacturing sectors.

Process Improvement 95

Process Improvement Packaging Vaccines FDA 95

BioPharm

FEBRUARY 20, 2024

We explore seed train intensification approaches which deliver significant upstream process improvements in speed, flexibility and reliability.

Process Improvement 40

Process Improvement 40

BioPharm

SEPTEMBER 8, 2022

Thu, Sep 8, 2022 11am EST | 8am PST | 4pm BST | 5pm CEST Digitalization & leveraging real-time data are key for biopharma process improvement. Insilico models and soft-sensors boost biopharma performance to unprecedented levels.

Process Improvement 40

Process Improvement 40

European Pharmaceutical Review

FEBRUARY 12, 2024

These innovative technologies include highly automated, fully digitalised process analytics technologies (PAT) , as well as automated and robotic testing technologies to confirm product quality. The complex and intricate processes involved in upstream and downstream manufacturing are highly refined, he notes.

Process Improvement 98

Process Improvement Packaging 98

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. These results are included in most recent paper.

Documentation 52

Documentation Process Improvement FDA 52

European Pharmaceutical Review

NOVEMBER 9, 2023

To ensure an efficient process, MyMD works closely with the contract manufacturing organisation (CMO) focusing on automation and process improvement. Quality materials, trained and capable labour, and efficient production processes are necessary for creating a finished product you are proud to market.

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies Immunization Process Improvement 115

European Pharmaceutical Review

AUGUST 29, 2022

They need to resolve any issues that affect cell performance and quality, whether it is media optimisation or process improvement. They also want to produce larger quantities of viable media in a timely manner.

Process Improvement 98

Process Improvement 98

Omnicell

JANUARY 10, 2023

It has developed a framework that identifies five levels of increasing technological capability and work process improvement spanning nine pharmacy work processes. The Advisory Board has coalesced around the clear vision of a fully autonomous pharmacy.

Medical Schools 52

Medical Schools Process Improvement 52

PQA

OCTOBER 22, 2024

Cooke, Research Associate Professor at the University of Maryland School of Pharmacy, Aaron Larson, VP of Health Plan Quality Analytics at UnitedHealth Group and Anita Pothen Skaria, Vice President of Quality and Process Improvement with Centene Corporation.

Process Improvement 52

Process Improvement Documentation 52

The FDA Law Blog

NOVEMBER 1, 2022

The bar for demonstrating comparability is high if a manufacturing change is introduced in the middle of a Phase 2 pivotal study versus if a sponsor introduces a process improvement between Phase 1 and before starting the Phase 2 pivotal study. Release testing alone is not sufficient.

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FDA Process Improvement 59

Impact Pharmaceutical Services

SEPTEMBER 15, 2023

Both processes are evolving to enhance product development and output. Upstream processing advancements encompass fed-batch processes , improved cell culture media, advanced feeding strategies, and tailored bioreactor control.

Documentation 59

Documentation Process Improvement Compounding 59

Fuld

JANUARY 21, 2020

We often deploy our Intelligence Benchmarking Survey as a barometer for process improvement opportunities with many of our clients and over the years have found that nearly 60 percent of the organizations we’ve surveyed struggle with demonstrating and managing the perceived value of competitive and market intelligence initiatives.

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Process Improvement Documentation 78

European Pharmaceutical Review

DECEMBER 1, 2023

For example, in selecting the best technology, we can obtain and use data-based analytics to design scale of tech transfer, to make scientific, data-based process improvements, and to bring efficiencies in process. Also, we can expect to see the utilisation of digital technologies for predictive modelling.

Dosage 98

Dosage Process Improvement FDA 98

Blog: Ask a Student Pharmacist

AUGUST 22, 2024

Paul Public Schools Social and Emotional Learning in Marginalized Youth + Adult Adults: Intellectual Disability Visual Support and Modeling to Promote Social Skill Development in Adults with Developmental Disabilities Improving Quality of Life for Autistic Adults by Increasing Occupations Based and Sensory Friendly Opportunities in the Community Developing (..)

Communication 52

Communication Process Improvement Hospitals 52

ISPE

OCTOBER 1, 2022

Consistent Measurements from Lab-to-Process Improve Production. Consistent Measurements from Lab-to-Process Improve Production. Trudy Patterson. Sat, 10/01/2022 - 06:00. Sponsored Content. 1 October 2022. Smooth scale-up requires the use of similar measurement technologies from the lab to full production.

Process Improvement 52

Process Improvement Communication 52

ISPE

OCTOBER 27, 2022

Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5. The synthesis unit operation routinely takes 8 to 12 hours start to finish, but it can take 3 to 5 days between batch starts using a single synthesis column.

Process Improvement 98

Process Improvement Packaging Compounding Dosage 98

ISPE

MARCH 29, 2023

2 Regulatory Binding Elements/ECs In the proposed comprehensive QOS, a summary of pharmaceutical development information along with a table that conveys the control strategy is provided.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

2 Regulatory Binding Elements/ECs In the proposed comprehensive QOS, a summary of pharmaceutical development information along with a table that conveys the control strategy is provided.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 7 An integrative (vs.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

SEPTEMBER 11, 2023

AI Technology There are multiple potential future applications of AI technology that can support more efficient technology transfer, scale-up, site monitoring, and regulatory submission processes (see Figure 2). This can simplify future scale-up and technology transfer.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 10, 2023

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

Fuld

OCTOBER 28, 2024

” Jeff Cruz Looking ahead, AI will likely evolve into niche applications that address specific stages of the M&A process, improving efficiency while maintaining the need for human expertise in more strategic areas. This is something firms will need to navigate carefully.”

Process Improvement 52

Process Improvement 52

Pharmaceutical Technology

MAY 9, 2023

For Jamaels, whose track record in managing complex operations and delivering process improvements spans GSK Vaccines and one of the world’s largest companies, GE, the technological shift is an exciting development: “I’m passionate about the digital transformation that our industry is going through,” he says.

Vaccines 52

Vaccines Process Improvement Communication 52