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
Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceuticalmanufacturing, the addition of AI technologies introduce a paradigm shift. Integrative Analysis of Multi-Omics Data with Deep Learning: Challenges and Opportunities in Bioinformatics.
The result is efficient, cost-effective and high-quality (bio)pharmaceuticalproduction. The most recent advances in PAT and associated technologies are further improving knowledge transfer and accessibility from R&D all the way to full-scale production plants. Enter the era of benchtop NMR solutions.
From the examination of raw materials through the release of the finished packaged product, Quality Control Authorities like Central Drugs Standard Control Organisation in India established under the Drugs & Cosmetics Act, 1940. They play a crucial role in assuring the efficacy and safety of products given to patients.
In our seven years of supporting AIdriven development and deployment at pharmaceutical companies, some common challenges often emergeissues that can undermine AI deploymentsimpacting accuracy, quality, and overall efficiency. These tools also improve overall dossier quality by flagging inconsistencies, inaccuracies, or missing information.
.” These products are disguised as legitimate branded medicines and it can be difficult for those across the supply chain, as well as patients, to detect counterfeit products from authentic originals. There is also the challenge of falsified medicines – the fake, unauthorised medical products that make their way into the market.
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.
Pharmaceutical wholesalers act as intermediaries between pharmaceuticalmanufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs.
Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. The unit comprises 2,000m 2 of Grade C and D, as well as an isolator for aseptic filling.
Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceuticalproducts. The download contains detailed information on commercial pharmaceutical packaging contractors, and their product and service lines, alongside contact details to aid your hiring decision.
Nitrosamines have garnered significant attention from the pharmaceutical industry due to their detection in commonly prescribed medications for conditions like type 2 diabetes, high blood pressure, and heartburn. [1]
Freeze drying is a crucial technique to prolong the shelf life of pharmaceuticalproducts. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.
In this instance of contaminated cough syrups, the concern is around an excipient in the product and not the active pharmaceutical ingredient (API). It is therefore essential that all components used in the pharmaceuticalmanufacturing process and not just the API must be assessed and tested to full monograph specifications.
In an age of disruption, technology is key to enabling pharmaceuticalmanufacturers monitor, track and control shipments and their processes. Pharmaceutical firms are changing the way they do business; the future winners will be highly automated and digitalised. Automation is about time and balance.
What are the top three supply-related challenges facing pharmaceuticalmanufacturers? Hayat Biotech’s global supply chain, spanning distribution to 64 countries, entails the involvement of multiple suppliers, distributors, and contract manufacturing organisations. How can these issues be addressed?
Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceuticalproducts. Regulatory body – NMPA : all pharmaceuticalproducts sold in the Chinese market need to be granted market authorization by NMPA.
Implementing PAT in (bio)pharmaceuticalmanufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility. Q13 Continuous Manufacturing of Drug Substances and Drug Products.
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