๐ง๐ต๐ฒ ๐๐บ๐ฝ๐ผ๐ฟ๐๐ฎ๐ป๐ฐ๐ฒ ๐ผ๐ณ ๐๐ผ๐น๐น๐ฎ๐ฏ๐ผ๐ฟ๐ฎ๐๐ถ๐ผ๐ป ๐ฏ๐ฒ๐๐๐ฒ๐ฒ๐ป ๐๐ต๐ฒ ๐๐ป๐ฎ๐น๐๐๐ถ๐ฐ๐ฎ๐น ๐ฎ๐ป๐ฑ ๐ฆ๐๐ป๐๐ต๐ฒ๐๐ถ๐ฐ ๐๐ต๐ฒ๐บ๐ถ๐๐๐ ๐๐ผ๐๐ฎ๐ฟ๐ฑ ๐ฎ ๐ฆ๐๐ฐ๐ฐ๐ฒ๐๐๐ณ๐๐น ๐ป๐ผ๐ป-๐๐ ๐ฃ/๐๐ ๐ฃ ๐ ๐ฎ๐ป๐๐ณ๐ฎ๐ฐ๐๐๐ฟ๐ถ๐ป๐ด ๐๐ฎ๐บ๐ฝ๐ฎ๐ถ๐ด๐ป The first stage in scaling up the manufacture of an active pharmaceutical ingredient (API) from laboratory to non-GMP/GMP production (i.e., g to kg) is the Process Research and Development (PR&D) phase. During the PR&D phase, the chemists are constantly refining the synthetic process to consistently achieve the desired API with a controlled impurity profile. This dynamic environment presents an excellent opportunity for collaboration between synthetic and analytical chemists. In this article, you will find three features of this collaboration that lead to a successful non-GMP/GMP manufacturing campaign. To find out more, visit https://lnkd.in/gkT2gBvq #Actylis #PartnerofChoice #Pharma
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Pharmaceutical Quality Control and Quality Assurance | Ensuring Excellence in Pharmaceuticals Safety and Compliance
Having spent years in wet chemistry labs, I've observed that staff tend to stick to familiar protocols, even if they aren't the most efficient. This makes introducing changes challenging, despite their potential to improve operations. It highlights the crucial need to establish and maintain an efficient lab environment. Adopting Continuous Improvement methodologies like Six Sigma, Lean, Kaizen, and others plays a key role in achieving streamlined operations within the lab. If you are curious to know how to implement Lean principles in a pharmaceutical QC lab, I encourage you to look at "Incorporating Lean Principles into Pharmaceutical QC Laboratory Design" published by NOVARTIS, BSM, Flad Architects, Foster Wheeler, JACOBS, and SANDOZ. #PharmaceuticalQAQC #ContinuousImprovement #SixSigma #Lean #Kaizen #LaboratoryOperations #WetChemistryLab
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The quality and technology are inherent to our products, and our team is proficient in developing versatile dosage forms for global markets. Our personnel, equipped with comprehensive training, are adept at managing all types of formulations. With over 100 scientists holding master's degrees and PhDs, our team brings a wealth of knowledge and expertise to our research and development endeavors. ย Our commitment to excellence is further exemplified by the strategic implementation of Design of Experiments (DOE) and Quality by Design (QbD) principles. Specifically, we have specialized drug delivery domain of Soft Gelatin Capsules with experts & technologists for handling complex product development and manufacturing technology enhancing our capabilities. This meticulous approach, guided by DOE andย (QbD)ย methodologies, not only ensures highest quality in our formulations but also contributes to the establishment of a world-class Research and Development facility at Strides Pharma. #synergICE #ResearchAndDevelopment #DosageForms #RnDExcellence #PharmaIndustry
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There are a number of key considerations when a project reaches larger scale production, including compliance, safety, quality, cost and more. In the below blog, we explore the key elements of successful pharmaceutical production and discuss how project teams can work to overcome challenges. #Engineering #Manufacturing #DrugManufacture #CDMO #PDMO #WeAreSterling
Journey of an API: Pharmaceutical engineering and production - Sterling Pharma Solutions
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Calibration and performance checks of analytical balances are crucial for maintaining accuracy and reliability in pharmaceutical quality control. ๐ Our latest article delves into best practices for adhering to Good Weighing Practice (GWP), ensuring compliance with regulatory standards, and delivering precise results every time. ๐ Discover how regular calibration helps detect and correct deviations caused by aging, environmental factors, and more. Stay ahead in the industry by implementing these essential practices. ๐ Read the full article and ensure your lab maintains the highest standards of precision and compliance. #GMPInsiders #Pharmaceuticals #QualityControl #AnalyticalBalances #Calibration #GoodWeighingPractice #GWP #LabManagement #Compliance #Precision
Calibration of Analytical Balances and Performance Checks as a Good Weighing Practice
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๐What is ๐๐๐๐ ๐๐๐๐ก๐ง๐จ๐ฅ๐จ๐ ๐ฒ? And what are they doing?๐ค ๐ฅWatch this video and learn more about one of our successful business partners, LAST TECHNOLOGY, the leading process equipment designer and manufacturer for the medical, research, and pharmaceutical industries, Engineering, custom automation, and industrial process management. โ๏ธ๐๐๐๐ ๐๐๐๐ก๐ง๐จ๐ฅ๐จ๐ ๐ฒ has been in the field of industrial engineering for over a decade, we deal with the development of unique machines and the handling of projects with a high technical level. โ๏ธ๐๐๐๐ ๐๐๐๐ก๐ง๐จ๐ฅ๐จ๐ ๐ฒ integrated design takes into account all aspects of the product life cycle, from prototype to product launch and validation, integrating all technological and normative aspects. โ๏ธProject management strengthened by field experience and solid technical know-how. ๐For more details, visit:โ www.lasttechnology.it/ ๐Follow us on LinkedIn lnkd.in/drvyxjp #Lasttechnology #Innoxengineeringย โ#Pharmaceuticalย #Pharmaย #Pharmaceuticalsย #Pharmaceuticalindustryย #Laboratoryย #containmentย #pharmaindustryย #GMPย #autoclavesย #sterilizerย #RSAย #steamautoclaveย #decontaminationย #Dryheatsterilizerย #Healthcareย #LABsterilizerย #labequipmentย #labย #cGLPย #dpbย #H2O2ย #sterilization
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ITQA Expert | CSV & QMS Specialist | Project Management Professional | Driving Quality & Compliance in Regulated Environments
Any manufacturing industry that wants to advance in the production process must first digitalize. In order to minimize costs, increase productivity and efficiency, and be adaptable to changes, the digitalization process entails switching from traditional paper-based systems to applications that use automation and computerization. However, the pharmaceutical industry has resisted digitization, mostly because of its lack of experience and the complexity of the development and manufacturing procedures involved. ย Here's an example to help you understand: if an event or deviation occurs in the manufacturing process, the investigation should be closed within 30 days. why 30 days because, the investigation process requires the review of extensive documentation, such as log books, BMRs, and BPRs, in order to distinguish between different CPPs and CQAs. Digitizing the processes will reduce the amount of time needed to collect and compile the data, allowing for the identification of differences in minutes as opposed to days.
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Obtaining desired particle attributes of drug substances reproducibly in production is technically very demanding. It requires multidisciplinary knowledges and experiences, especially in physical chemistry, chemical engineering, material sciences, process analytics, pharmaceutical regulations, etc. The team of Center for Pharma Crystallization at Porton has been built to address such challenges and delivered countless high standard solutions for obtaining desired particles attributes via controlled crystallization and/or precipitation processes. We strive to provide highly customer focused and efficient R&D services in addressing crystallization/precipitation challenges for drug development programs worldwide. #particleattributes #drugsubstance #crystallization #precipitation #centerforpharmacrystallization #porton #portonpharmasolutions
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Manager Research and Development,CDMO Project lead, NPD & NPLs Specialist.Technical support in B.E,Scale-up process.QbD expert
Technology transfer Series: (Part 4): 3) Comparison Report: During the transfer of pharmaceutical technology, the Receiving Unit must take certain vital actions in order to generate a comparability report. First, a thorough assessment of the machinery, manufacturing procedures, and analytical techniques used by the source unit is carried out. This assessment aids in locating any possible discrepancies or gaps between the receiving and source units. Second, a comprehensive evaluation of the product's critical quality attributes (CQAs) is carried out. This entails examining the drug substance's or product's stability and impurity profiles in addition to its physical, chemical, and biological properties. Any differences or inconsistencies can be found and fixed by contrasting these qualities with the specified requirements. After that, a thorough risk assessment is carried out to determine how any discrepancies or gaps might affect the product's quality, safety, and efficacy. This stage aids in setting priorities and estimating the amount of work needed to close any gaps and guarantee comparability. After the risk assessment, a thorough plan is created to close the gaps found and guarantee comparability. This approach could involve equipment upgrades, process changes, method validations, or even more research to show that the source and receiving units are equivalent. The comparison report, which summarizes all the conclusions, actions done, and supporting information, is then finalized. This report shows the strength of the technology transfer process and is an essential document for regulatory filings.#technologytransfer #productdevelopment #processoptimization #learninganddevelopment Pic Courtesy: https://lnkd.in/dxv--5R6
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Manufacturing efficiency can be drastically improved by clear indications of the areas in the process flow. clear labeling of areas are key to process oriented manufacturing. #industrialsigns #processindicatior#processlocationsigns #asktheisignlady #signaramacbd #Thalessg
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