Famar is an Athens-based pharmaceutical contract development and #manufacturing organisation. Nina Lindholm #Pharmaceuticals #Healthcare #Industrial #PEDeals
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June Pharma Industry Updates: Here are the key highlights from the pharmaceutical sector this June. #Unitedpharmatechnologies #Pharmaceuticals #StaffingNews #NewHires #Healthcare #Innovation
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Ensuring precise results in our labs is crucial! At Walter Healthcare, we adhere to strict guidelines, from traceable reference materials to meticulous record-keeping. Our commitment to GLP guarantees safety, quality, and integrity in every step of pharmaceutical development. #QualityAssurance #WalterHealthcare #GLP #pharmaceutical #pharma #contractmanufacturing #contractmanufacturer #pharmaceuticalmanufacturing
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Quality Assurance ! Quality Compliance ! QMS ! IPQA! Biological product ! Analytical Method transfer and Validation ! Analytical Quality Assurance
Topic: Out of Specification in Pharmaceutical Industries
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Do you work in pharmaceutical labeling or packaging? 💊 Do you sell into the UK market? 🌍 Download our free guide today on the Windsor Framework Regulations and get ready for the changes to regulatory requirements coming this year! https://lnkd.in/eFZ78p_z #labeling #packaging #pharmaceuticals #WindsorFramework #labelingsolutions #labelling #kallik Kallik
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GREAT POST ABOUT Key Steps of Pharmaceutical Product Release
8 Key Steps of Pharmaceutical Product Release Are you involved in the pharmaceutical industry and curious about the key steps involved in releasing a new product? Look no further! #Pharmaceutical #Industry #Product #Healthcare #Regulatory
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Releasing a pharmaceutical product is not as simple as just putting it on the market. It requires a meticulous and extensive process to ensure the safety and efficacy of the product. The first step in the pharmaceutical product release process is manufacturing. This involves producing the drug in accordance with Good Manufacturing Practices (GMP) to ensure the product is of high quality and free from contamination. The next step is testing. This includes both pre-release testing of the product to ensure it meets specifications and post-release testing to monitor its stability and quality over time. This can involve a range of tests such as dissolution testing, microbiological testing, and potency testing. Once the product has been manufactured and tested, it must undergo regulatory review. This involves submitting data to regulatory agencies such as the FDA or EMA to demonstrate the safety and efficacy of the product. This can be a lengthy and complex process that requires extensive documentation and testing. After regulatory approval has been obtained, the product can finally be released to the market. However, this is not the end of the process. Ongoing monitoring and surveillance are essential to ensure the ongoing safety and efficacy of the product. Overall, the steps of pharmaceutical product release require careful planning, meticulous execution, and strict adherence to regulations. Any misstep can have serious consequences for patients and can lead to costly recalls and legal implications. It is essential that pharmaceutical companies prioritize quality and safety throughout the entire product release process.
8 Key Steps of Pharmaceutical Product Release Are you involved in the pharmaceutical industry and curious about the key steps involved in releasing a new product? Look no further! #Pharmaceutical #Industry #Product #Healthcare #Regulatory
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From material tracking, to fabrication processes and quality control measures, Moorfeed Corporation A Division of EAS has the knowledge and abilities to fulfill the special requirements set by the medical and pharmaceutical industries. Learn More https://shorturl.at/mMWXZ #FDAapprovedProduct #FDA #FDAapproval #pharmaceutical #QualityControl #vibratorybowl #vibratoryfeederbowl
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8 Key Steps of Pharmaceutical Product Release Are you involved in the pharmaceutical industry and curious about the key steps involved in releasing a new product? Look no further! #Pharmaceutical #Industry #Product #Healthcare #Regulatory
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Here are the key steps involved in pharmaceutical product release: 1. Formulation development: The first step in pharmaceutical product release is formulating the drug with the appropriate active ingredients and excipients to ensure its effectiveness and stability. 2. Preclinical testing: Before a pharmaceutical product can be released, it must undergo rigorous preclinical testing to evaluate its safety and efficacy in animal models. 3. Clinical trials: Once the preclinical testing is complete, the drug must undergo clinical trials in humans to determine its safety and effectiveness. This process typically involves three phases, with each phase involving more participants and more rigorous testing. 4. Regulatory submission: After the clinical trials are complete, the pharmaceutical company must submit a New Drug Application (NDA) or a Biologics License Application (BLA) to the regulatory authority in the country where they wish to market the product. This application includes all the data from the preclinical and clinical trials, as well as information about the manufacturing process and quality control measures. 5. Review and approval: The regulatory authority will review the NDA or BLA and decide whether to approve the pharmaceutical product for release. This process can take several months to several years, depending on the complexity of the drug and the volume of data submitted. 6. Manufacturing and quality control: Once the pharmaceutical product is approved, the company must manufacture it according to strict guidelines to ensure its safety, efficacy, and quality. This involves regular testing and monitoring of the product throughout its lifecycle. 7. Distribution and marketing: Finally, the pharmaceutical product can be released to the market, where it will be distributed to pharmacies, hospitals, and other healthcare providers. The company will also engage in marketing efforts to promote the product to healthcare professionals and consumers.
8 Key Steps of Pharmaceutical Product Release Are you involved in the pharmaceutical industry and curious about the key steps involved in releasing a new product? Look no further! #Pharmaceutical #Industry #Product #Healthcare #Regulatory
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🚀 Just Released: 2024 #WHO Guidance on Quality Assurance of Pharmaceuticals! 📚 Exciting news for the pharmaceutical industry - the Tenth Edition of the WHO compendium of guidelines and related materials is now available. Volume 2 focuses on Good Manufacturing Practices and Inspection, providing essential information for ensuring quality in pharmaceutical production. Don't miss out on this valuable resource - download your copy in the #Pharmatalks community on Telegram today! 👇👇👇 #Pharmaceuticals #QualityAssurance #GoodManufacturingPractices #WHO #Guidelines #IndustryUpdates 🌟 Link to download: https://lnkd.in/eH2ie6ms 📲💊🔬
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