Pharmaceutical Manufacturing Resource

Time 2020-12-15 16:04:09

Web Name: Pharmaceutical Manufacturing Resource

WebSite: http://www.pharmaceuticalonline.com

ID:135090

Keywords:

Pharmaceutical,Manufacturing,Resource,

Description:

Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: The M&A And Commercial Landscape In this last part in a three-part series, we cover the M A and commercial landscape implications, including historical and future deal trends, challenges in developing a successful commercial strategy, and what to watch out for as the NASH industry continues to reach new milestones. Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: The Second-Wave Candidates In Part 1 of this three-part series, we discussed NASH, the market for treatments, the first wave of NASH drugs (at Phase 3) poised to change the management paradigm, and the currently ambiguous pricing/reimbursement landscape. Here in Part 2, we look to the most promising second wave of NASH drugs. Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products A simple time to clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning. Slow-walking The Isolator — A Cautionary Tale Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s. Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: Sizing Up The First Wave NASH has remained a relative graveyard of drug development over the past 40 years: no disease-specific approved therapies have made it to market. This article analyzes the first wave of drugs (at Phase 3) poised to change the NASH management paradigm and shape the ambiguous pricing and reimbursement landscape. A Framework For Managing The Quality And cGMP Compliance Capability Of Your CMOs When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP. Advancing The State Of Aseptic Processing: Let’s Get Serious It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies. Mitigating Risks To Global Distribution Of COVID-19 Vaccines And Therapeutics All partners in the vaccine supply chain recognize that the supply chain challenges posed by COVID-19 must be assessed and mitigated. Increased monitoring and corrective and preventive actions of supply chain issues and technical support for analytical challenges need to be addressed. System Impact Assessment: A Risk Management Framework For A COVID World Infusing risk management is essential to an organization, especially in terms of facility, utility, and equipment qualification. Although qualification is usually the last step before moving to process characterization and validation, integrating a risk management approach is an effective way to ensure qualification activities are focusing on what matters most that equipment performs as expected. The newly drafted USP 922 General Chapter describes the specific methods that pharmaceutical companies will use to calibrate, qualify, and use water activity instruments in their testing protocols. USP 922 includes a description of Tunable Diode Laser Absorption Spectroscopy (TDLAS) measurements and states that it is the only method to reliably and accurately measure water activity when the sample contains other volatile compounds. The Lighthouse FMS-Water Activity Analyzer uses TDLAS to non-destructively and directly measure the water activity non-invasively of samples in a sealed glass vial. Guidelines To Bring Your Biologic To Market: Are You Prepared? Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective. Equipment Safety For Product Inspection Equipment This paper is intended as a general guide on equipment safety, for users and suppliers of product inspection equipment. It should be thought of as a framework for discussion on the topic, assisting both users and suppliers in meeting their shared responsibility for equipment safety. 2D And 3D Pre-Designed Solutions For Storage And Shipping Single-use incGMP production requires enhanced assurance of supply and product performance. Innovative bioprocessing bag technology meets these challenges for every process step and application. Preventing Sticking And Picking Through Tablet Design Sticking or picking issues are often not detected. Prevent unanticipated problems during scale-up and full-scale production by considering tablet compression issues before tablet designs are finalized. Product Development For An Oral Solid Dosage Using Continuous Manufacturing A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product. Get the latest articles from Pharmaceutical Online delivered to your inbox. We all within this and every industry, endeavor to get back to full productivity, which requires production. When production happens, so to do procedural errors. This guide is a critical look at the best and most fundamental methods employed over many years to help innumerable companies prosper. The net result of this information sharing is that the future of healthcare, in all of its forms, gets better for humanity. We can all only benefit from better approaches to our work and smarter problem-solving. This website uses cookies to ensure you get the best experience on our website. Learn more

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Pharmaceutical manufacturing industry and suppliers - critical environment,particle sizing,pharma process control,pharma material handling,tablet production,particle sizing, pharma material handling, pharmaceutical packaging

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