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Revolutionising pharma the adaptive way Pharmaceuticalmanufacturing is undergoing a transformative development, driven by innovative technologies that enable right-first time (RFT) production and adaptive scaling to meet changing demands. Why is adaptive manufacturing necessary?
PharmaceuticalManufacturing & Packaging Congress (PHARMAP 2022) covers the current state of the pharmaceuticalmanufacturing and packaging industry. The Congress gathers pharmaceuticalcompanies, CMOs and CDMOs, governmental bodies together with pharmaceutical equipment providers and service companies.
What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceuticalmanufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands.
Pharmaceuticalcompanies face unique challenges due to their rapid digital transformation, adopting Internet of Things (IoT), Artificial Intelligence (AI), and blockchain technologies. Cybersecurity Challenges Intellectual Property Theft: Pharmaceuticalcompanies invest heavily in research and development. With over 1.9
Microbes developing resistance to disinfectants is a major emerging problem in pharmaceuticalmanufacturing cleanrooms and, if left unchecked, could present a threat to drug quality and, therefore, human health. Reducing this concentration twice, the researchers found that at the lowest concentration M. luteus and S.
[pharmaceuticalcompanies] 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.
His presentation will focus on “MoCRA is Here – Now What? His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceuticalcompanies to CROs and academic researchers to patient advocacy organizations. On March 20-21, Counsel John W.M.
What are the three main challenges of monitoring pharmaceuticals in the environment? Andreas Häner (AH): Roche, along with other pharmaceuticalcompanies, acknowledges concerns about pharmaceuticals in the environment (PiE). The difference between detection limits and quantitation limits is very important.
The event is a joint initiative between AIPAC, Society for Pharmaceutical Dissolution Science (SPDS), Indian Drug Manufacturers Association-MP State Board (IDMA-MP), and Madhya Pradesh State Drugs and PharmaceuticalManufacturers Association (MPSDMA).
COVID-19 has sped up the digital transformation and forced pharmaceuticalcompanies to rethink many aspects of their business. Continuous manufacturing The topic of continuous manufacturing is also discussed in frames of PHARMAP 2023. This leads to growth in the pharma industry by finding new solutions and innovations.
PCM not ideal for every drug Continuous manufacturing “may not be fit for every pharmaceuticalmanufacturing process, but it can bring some advantages in some cases” compared with traditional batch manufacturing, summarized FDA’s Adam Fisher, Ph.D., Why is continuous better? Executive Director at Eli Lilly.
3) policing anticompetitive settlements between competing drug manufacturers. European pharmaceuticalcompanies targeting the US market should be aware of these pending bills and their potential impacts on market entry, intellectual property enforcement and payer access. 5) monitoring access to biosimilars.
So what do exactly HEOR experts do for the pharmaceuticalcompanies and what HEOR-collected data is used for? HEOR collects all reports about health outcomes from patients and physicians and later provides detailed analytics to healthcare providers, clinical outcomes research institutions or pharmaceuticalcompanies.
Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceuticalmanufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.
The theme of the event was Innovation, Advanced Technology, Current Challenges & Opportunities in Pharma & Healthcare Industry under which a series of presentation sessions and panel discussions were held related to pharma trends, APIs, policy reforms, AI, metaverse, current regulatory trends and the direction of pharma and drug discovery.
Regulatory authorities require them to produce evidence that the processes and systems are validated, critical equipment is qualified, and manufactured products are tested for purity. Pharmaceuticalcompanies are accountable for properly warehousing, shipping their products, and guaranteeing their stability until expiry.
As the sector continues its rapid expansion, with a 7 per cent annual growth rate, the event will highlight the increasing reliance on contract development and manufacturing organisations (CDMOs) in bringing new therapies to market. The event will also present new industry research from Simon-Kucher.
Production run charts Run charts are often used to monitor manufacturing processes. Through meticulous line clearance procedures, pharmaceuticalmanufacturers can uphold GMP standards and safeguard product quality and safety. When these checks are done by production staff, the check should be audited by the Quality Department.
GMP requires that all critical steps of manufacture are reliable or validated. How to perform sampling in quality control process Sampling is the removal of a presentative portion of a lot to understand the lot’s composition and characteristics. This naturally includes laboratory test methods.
Scheduled to take place from January 27-30, 2025, at the World Trade Center (WTC), Dubai to be inaugurated by Satish Kumar Siven, Consul General of India to UAE, at Dubai on January 27, 2025 this event will feature participation from 65 leading Indian pharmaceuticalcompanies.
The event brought together over 330 professionals from across the industry’s value chain PharmaceuticalManufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. Among the attendees, contract manufacturing organisations, service providers and experts were present.
Also, the proliferation of antimicrobial resistance (AMR), where overuse of antibiotics leads to resistant bacteria, making infections harder to treat Additionally, pharmaceuticalmanufacturing consumes substantial amounts of solvents, which are typically highly toxic chemicals, as well as heavy metals.
In the 1990s, generic pharmaceuticalcompanies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. Moreover, US Pharmacopeia issued the first-ever Medicine Supply Map to find and quantify risks in upstream pharmaceutical supply chains across the country.
This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceuticalcompanies must adhere to for optimal cleanliness and safety. Sometimes, pharmaceuticalmanufacturers employ surface profilometry to assess the roughness of stainless-steel equipment.
This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceuticalcompanies must adhere to for optimal cleanliness and safety. Sometimes, pharmaceuticalmanufacturers employ surface profilometry to assess the roughness of stainless-steel equipment.
Antibiotic production processes involve a risk that, if operations and waste management practices are not strictly controlled, antibiotic can leave manufacturing plants in waste water, for example, and enter the environment in concentrations that may increase the risk of AMR. Frontiers in Microbiology. Tell J, Caldwell D, Häner A, et al.
Particularly the printed packaging materials where product information is presented. – When new printed material to the line double-check that the correct printed material has been selected and presented to the line. Accurate packaging prevents mix-ups and complies with Good Manufacturing Practice (GMP) rules.
The practice of calling a piece of equipment clean just because it looks clean is not acceptable in the pharmaceuticalmanufacturing process. The amount of residue if present is assessed to have no harmful effect on human use. Why is cleaning validation required? NOEL stands for No Observable Effect Level in cleaning validation.
We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. These requirements mandate that pharmaceuticalcompanies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.
The Evolving Role of CDMOs in the Pharmaceutical Industry Gone are the days when CDMOs were mere service providers. Today, they’re strategic partners in drug development and manufacturing, offering end-to-end solutions that can make or break a pharmaceuticalcompany’s success.
Increased API costs may force some manufacturers to reduce output or exit the market entirely, reducing competition and potentially driving price inflation. For branded pharmaceuticalcompanies, the impact may be less immediate due to their larger profit margins.
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