This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
This poses a significant challenge for pharmaceuticalmanufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.
Actions can include optimising behind-the-meter assets, procuring renewable energy through power purchase agreements (PPAs), and participating in capacity, ancillary and energy market programmes to optimise energy use and support the electricity grid to manage increasing levels of renewable energy. Resiliency and renewables.
The Fourier PAT includes a Fourier 80 compact NMR analyser equipped with a synTQ NMR dadpter that enables the integration with synTQ PAT knowledge management software. This can lead to refined (bio)pharmaceuticalmanufacturing operations that propel product quality, operational efficiency and overall productivity to new heights.
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 pharmaceuticalmanufacturing site quality rating system, the Quality management maturity (QMM) programme.
Register your details now to download >>> This Pharma Horizons report is brought to you in association with: The post Pharma Horizons: Sustainability appeared first on European Pharmaceutical Review. Interested?
Roquette Pharma Solutions' Christine Mya-San, global account manager, highlights the most significant pharma ingredients at play over the past year and discusses future ingredient innovation.
Aurobindo Pharma-Openings for Freshers – Project Management -Apply Now. APL is a growing India multinational pharmaceuticalmanufacturing firm with turnover of over US$2.8 Department: Project Management. Aurobindo Pharma-Openings for Freshers – Project Management -Apply Now.
The Parenteral Drug Association (PDA)’s long-awaited Technical Report 90: Contamination Control Strategy Development in PharmaceuticalManufacturing is now available. Dr Madina Karimova, Quality Assurance Manager at Sanofi shared her opinion on PDA’s TR 90 report, highlighting parts she found valuable.
Delpharm has acquired the Meppel pharmaceuticalmanufacturing facility in the Netherlands from Astellas. We are delighted to further expand our operations in the Netherland with this [third] site,” commented Nicolas Ragot, Managing Director of Delpharm.
Warning letters issued by FDA can be an important source of data to study and analyse violations that occur in pharmaceuticalmanufacturing. Such studies can also help companies prepare for their upcoming inspections by enabling them to identify and rectify any issues.
Included in this Guide to Data Integrity: The significance of data integrity in pharmaceuticalmanufacturing Are you leveraging all the information from your quality control data? A secure, compliant and powerful data management system is critical for maintaining your data integrity compliance.
A market report by Meticulous Research has reported that rising pressure to reduce overall process costs has meant many pharma and biotech manufacturers are focusing on streamlining their processes by using quality management systems. What is driving adoption of quality management systems in pharma? billion by 2030.
This document outlines key strategies and testing protocols critical for optimizing EPCIS implementation, ensuring that pharmaceuticalmanufacturers can maintain compliance and operational efficiency.
Identification of environmental isolates is a regular requirement in pharmaceuticalmanufacturing, and strain differentiation can be valuable in a variety of circumstances.
Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceuticalmanufacturing facilities, avoiding the need for duplicate inspections.
True adherence cannot exist without total health management, and how we manage it matters. Simplification In an increasingly complex healthcare system, it’s very easy to over-engineer a single aspect of health when in reality, what we need is a simplification of how we manage all aspects of our health. Luke received his B.A.
Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Aside from the increasing volumes of data, submission teams have other reasons for moving to component management.
Reflecting on five years of quality control for nitrosamine impurities Warning Letters In FY2022, the FDA issued 72 CGMP-related warning letters to pharmaceuticalmanufacturing sites. Most that received warning letters (68 percent) were FDF manufacturers of non-sterile, non-application products.
In an EPR article on the AMR certification published in June, Courtney Soulsby, BSI Global Director, Healthcare Sustainability and Steve Brooks, Manufacturing Working Group Chair for the AMR Industry Alliance shared: “Certification to the Manufacturing Standard has the potential to positively impact global antibiotic supply through antibiotic emission (..)
Due diligence teams will review your pharmaceutical quality system – to verify if it is operational and effective. This review will include key documents such as minutes of management review meetings and quality metrics which will enable them to quickly assess the company’s approach to quality and compliance and the current level of control.
However, with cleanrooms-on-demand representing a feasible and accessible opportunity for those across pharmaceuticalmanufacturing, what are the key challenges in adoption and how can we expect the industry to overcome them to reap the rewards on offer? But with a single dedicated cleanroom environment costing around $2.5
This document details the benefits of DataX, a revolutionary solution tailored for pharmaceuticalmanufacturers. Designed to navigate the complexities of managing serialized data for drop shipments, DataX ensures secure, compliant, and efficient data exchange.
While the current production facility in Chartres, France, employ around 1,600 people, once the new multi-product facilities are in operation, over 500 new jobs will be created to manage continuous production activities. The facility will support process development, good manufacturing practice (GMP) manufacturing, as well as product release.
The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceuticalmanufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?
International Federation of PharmaceuticalManufacturers and Associations (IFPMA), the global trade body for the biopharmaceutical industry , has announced its new CEO leadership team for the next two years. Who is joining IFPMA’s new CEO leadership team? The C-suite lineup includes Albert Bourla, Chairman and CEO of Pfizer.
Construction of the LUnA research building means AbbVie Germany “can conduct cutting-edge research at our site in the long term,” stated Martin Gastens , Vice President, Biologics Drug Product Development and Managing Director R&D, AbbVie Germany.
Andreas Häner (AH): Roche, along with other pharmaceutical companies, acknowledges concerns about pharmaceuticals in the environment (PiE). These professionals also support sustainability by promoting responsible effluent management practices that go beyond compliance.
For further information, visit: www.criver.com About the authors Courtney Wachtel, BS is Product Manager, Microbial Solutions, Charles River – Endosafe. She has a BS in biology from Georgia Tech, certifications in integrative and biomedical biology, and 10 years of experience in the pharmaceutical industry.
Stuart Lemmon, CEO of EcoAct and Managing Director of the Net Zero Transformation practice at Atos commented: “It is positive that three in four businesses intend to reach net-zero… [especially as] many businesses have become well-versed in the requirements of climate disclosures.” This statistic was 96 percent for Scope 3.
Consequently, pharmaceuticalmanufacturers risk their reputation if impersonating products fail to deliver the expected quality or health impact. For manufacturers, this allows for greater protection of products courtesy of real-time tracking data and the ability to refine and secure supply chains by spotting weak links.
[pharmaceutical companies] must take measures to manage antibiotic waste across the manufacturing supply chain” 2023 has so far, delivered a spectrum of change for antibiotic manufacturers across the pharmaceutical industry, from supply chain issues through to regulatory opportunities.
APL is a growing India multinational pharmaceuticalmanufacturing firm with turnover of over US$2.8 We hiring senior Manager/ Assistant General Manager in QC/ QA/ Microbiology @ Aurobindo Pharma Department: QC/ QA/ Microbiology Qualification: M.Sc Greetings from Aurobindo Pharma !!!
APL is a growing India multinational pharmaceuticalmanufacturing firm with turnover of over US$2.8 Positions: Technician to Assistant Manager/ Dy. Aurobindo Pharma-Openings for B.Tech/ Diploma in Engineering OSD Dept.-Apply Company Profile: Aurobindo Pharma Ltd’ (APL). Greetings from Aurobindo !!! Experience: 4 to 12 years.
Articles included in this In-Depth Focus include: Best practices in environmental monitoring of compressed gas ports Environmental monitoring exerts from Cambrex, Ryan Brough, Peter Lisowski and Alicia Vicau, share their expertise in best practice for monitoring compressed gas ports to minimise contamination risks Understanding EMPQs: Successful Contamination (..)
Pharmaceutical companies are increasingly integrating data-driven and software-centric medical adherence products to improve patient compliance. Many companies use artificial intelligence (AI) to enable pharmaceuticalmanufacturers to overcome barriers to medication adherence.
Applying AI to GVDs Amassing comprehensive productand market-related data, GVDs demonstrate the value of a pharmaceutical product to various stakeholders, including payers, healthcare providers, and regulatory bodies. It leveraged experts input at key points in the process, to assess and validate the work.
Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the pharmaceutical industry. Between May 1, 2016, and May 31, 2021, 42% of all U.S. Certain markets (e.g.,
The CDSCO headquarters conduct regulatory supervision over drug importation, approval of new pharmaceuticals and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and approval of some licences as the Central Licence Approving Authority.
Steril-Gene Life Sciences, Pondicherry (A Group Unit of the Madras Pharmaceuticals) one of the most reputed FDA approved Pharmaceuticalmanufacturing Company looking suitable Candidates for the below positions. Management Trainee. Department: QC/ QA/ QC-Micro/ Production/ Technology Transfer. Positions: Jr.
The post Leading API chemical companies in contract marketing appeared first on Pharmaceutical Technology. The document contains detailed information on the suppliers and their products, alongside contact details to aid your purchasing or hiring decisions.
When questioned about which technologies he considered have potential to advance the sector, Chornet emphasised that not only is mRNA as a vaccine technology “a very promising and interesting platform [but that it is] disruptive and a game changer technology for vaccine [manufacturing] and overall biotech.”
As a treatment designed to help halt disease progression before symptom onset, “Zolgensma will be the first treatment to be routinely commissioned for presymptomatic babies in England,” Imran Kausar, General Manager at Novartis Gene Therapies UK explained. According to CPI, the facility is set to be completed in late 2025.
We organize all of the trending information in your field so you don't have to. Join 8,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content