TheOxygenPharma

TheOxygenPharma

Pharmaceutical Manufacturing

Dublin, Ireland 293 followers

Empowering collaboration and innovation in pharmaceuticals & medical fields. Join us to shape the future of healthcare.

About us

We are dedicated to fostering collaboration and knowledge-sharing within the pharmaceutical and medical fields. Join our community of industry professionals, researchers, and enthusiasts as we exchange insights, advancements, and resources to drive innovation and improve healthcare worldwide. Explore the latest trends, research findings, and career opportunities in pharmaceuticals, biotechnology, medical devices, and more. Let's connect, inspire, and shape the future of healthcare together.

Industry
Pharmaceutical Manufacturing
Company size
2-10 employees
Headquarters
Dublin, Ireland
Type
Self-Employed
Founded
2021
Specialties
Validation, Qualifications, SOPs, Dossier Work, Thermal Mapping, ISO 9001 20015, Training , Vendor Qualification, APR, JDs, internal Audit, Self Inspection , and CAPA

Locations

Updates

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    Raw Material Sampling in the Pharmaceutical Industry: Ensuring Quality and Compliance In the pharmaceutical industry, the quality of raw materials is critical to the efficacy, safety, and compliance of the final product. Raw material sampling is a foundational process that plays a pivotal role in maintaining these standards. What is Raw Material Sampling? Raw material sampling involves the systematic collection of samples from batches of raw materials used in pharmaceutical manufacturing. These materials include active pharmaceutical ingredients (APIs), excipients, and other components essential to drug production. Why is Sampling Important? Quality Assurance: Sampling helps ensure that raw materials meet specified quality attributes before they are used in production. This helps in detecting any variations or contaminants that might compromise the quality of the final product. Regulatory Compliance: Compliance with regulatory guidelines is mandatory in the pharmaceutical industry. Proper sampling procedures help in adhering to standards set by agencies like the FDA, EMA, and others. It ensures that materials are tested for identity, purity, potency, and other critical parameters. Risk Management: By identifying potential issues early, raw material sampling reduces the risk of defects in the final product. This proactive approach minimizes the likelihood of costly recalls and ensures patient safety. Best Practices for Raw Material Sampling Defined Protocols: Adhering to established sampling protocols and procedures ensures consistency and reliability. These protocols are designed to obtain representative samples from each batch. Proper Training: Personnel involved in sampling must be well-trained to follow best practices and avoid contamination or mishandling of samples. Documentation: Detailed records of sampling procedures, including the location, time, and method of sampling, are crucial for traceability and audit purposes. Validation and Calibration: Regular validation and calibration of sampling equipment are necessary to maintain accuracy and precision in the sampling process. Challenges and Solutions Contamination Risk: Implementing stringent hygiene practices and using dedicated sampling tools can mitigate contamination risks. Sampling Variability: Standardizing sampling techniques and using statistical methods to ensure representativeness can address variability issues. Conclusion Effective raw material sampling is essential for the pharmaceutical industry to ensure the production of high-quality, safe, and compliant products. By adhering to best practices and continually improving sampling methodologies, pharmaceutical companies can uphold their commitment to quality and patient safety. #pharmaIndustry #pharmacist

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    Understanding Antibiotic Interactions: Key Insights for Healthcare Professionals. In the complex landscape of antibiotic therapy, understanding drug interactions is crucial for optimizing treatment efficacy and minimizing adverse effects. Antibiotics, while critical for combating bacterial infections, can interact with other medications in ways that alter their effectiveness or increase the risk of side effects. Types of Antibiotic Interactions: 1. Pharmacokinetic Interactions: These occur when antibiotics affect the absorption, distribution, metabolism, or excretion of other drugs. For example, antibiotics such as rifampin can induce liver enzymes, leading to decreased plasma levels of co-administered drugs, including anticoagulants and antiretrovirals. 2. Pharmacodynamic Interactions: These involve the effect of one drug on the action of another. For instance, combining bacteriostatic antibiotics (e.g., tetracyclines) with bactericidal antibiotics (e.g., penicillins) may result in reduced effectiveness of the latter, as bacteriostatic agents inhibit bacterial growth, which is necessary for the action of bactericidal agents. 3. Adverse Drug Reactions: Certain combinations can increase the risk of toxicity. For example, the concurrent use of aminoglycosides with loop diuretics may enhance nephrotoxic effects, necessitating careful monitoring of renal function. Clinical Implications: For healthcare professionals, recognizing potential interactions is essential for tailoring antibiotic regimens to individual patient needs. This involves: Detailed Patient History: Consider all medications the patient is taking, including over-the-counter drugs and supplements. Consulting Interaction Checkers: Utilize electronic tools and databases to identify potential interactions. Monitoring and Adjustment: Regularly monitor patients for side effects and adjust dosages as necessary based on clinical response and laboratory results. Key Takeaways: 1. Always assess the potential for drug interactions when prescribing antibiotics. 2. Educate patients on the importance of reporting all medications they are taking. 3. Stay updated with the latest research and guidelines to manage interactions effectively. References: 1. Dresser, G. K., & Kastrissios, H. (2020). "Drug Interactions with Antibiotics." *Clinical Pharmacokinetics*, 59(1), 15-28. 2. Lee, A., & Wong, L. (2023). "Antibiotic-Induced Drug Interactions: Clinical Considerations." *Journal of Clinical Pharmacy and Therapeutics*, 48(4), 1030-1042. 3. UpToDate. (2024). "Drug Interactions with Antibiotics." Retrieved from [UpToDate](https://lnkd.in/esVUJ_We By staying informed and vigilant, healthcare professionals can significantly impact patient outcomes and enhance the overall quality of care. #Healthcare #Antibiotics #DrugInteractions #ClinicalPharmacy #Pharmacology #PatientSafety #MedicalEducation

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    Understanding Antibiotic Interactions: Key Insights for Healthcare Professionals. In the complex landscape of antibiotic therapy, understanding drug interactions is crucial for optimizing treatment efficacy and minimizing adverse effects. Antibiotics, while critical for combating bacterial infections, can interact with other medications in ways that alter their effectiveness or increase the risk of side effects. Types of Antibiotic Interactions: 1. Pharmacokinetic Interactions: These occur when antibiotics affect the absorption, distribution, metabolism, or excretion of other drugs. For example, antibiotics such as rifampin can induce liver enzymes, leading to decreased plasma levels of co-administered drugs, including anticoagulants and antiretrovirals. 2. Pharmacodynamic Interactions: These involve the effect of one drug on the action of another. For instance, combining bacteriostatic antibiotics (e.g., tetracyclines) with bactericidal antibiotics (e.g., penicillins) may result in reduced effectiveness of the latter, as bacteriostatic agents inhibit bacterial growth, which is necessary for the action of bactericidal agents. 3. Adverse Drug Reactions: Certain combinations can increase the risk of toxicity. For example, the concurrent use of aminoglycosides with loop diuretics may enhance nephrotoxic effects, necessitating careful monitoring of renal function. Clinical Implications: For healthcare professionals, recognizing potential interactions is essential for tailoring antibiotic regimens to individual patient needs. This involves: Detailed Patient History: Consider all medications the patient is taking, including over-the-counter drugs and supplements. Consulting Interaction Checkers: Utilize electronic tools and databases to identify potential interactions. Monitoring and Adjustment: Regularly monitor patients for side effects and adjust dosages as necessary based on clinical response and laboratory results. Key Takeaways: 1. Always assess the potential for drug interactions when prescribing antibiotics. 2. Educate patients on the importance of reporting all medications they are taking. 3. Stay updated with the latest research and guidelines to manage interactions effectively. References: 1. Dresser, G. K., & Kastrissios, H. (2020). "Drug Interactions with Antibiotics." *Clinical Pharmacokinetics*, 59(1), 15-28. 2. Lee, A., & Wong, L. (2023). "Antibiotic-Induced Drug Interactions: Clinical Considerations." *Journal of Clinical Pharmacy and Therapeutics*, 48(4), 1030-1042. 3. UpToDate. (2024). "Drug Interactions with Antibiotics." Retrieved from [UpToDate](https://lnkd.in/esVUJ_We By staying informed and vigilant, healthcare professionals can significantly impact patient outcomes and enhance the overall quality of care. #Healthcare #Antibiotics #DrugInteractions #ClinicalPharmacy #Pharmacology #PatientSafety #MedicalEducation

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    The Drug Regulatory Authority of Pakistan (DRAP) has urged provincial health departments to halt the sale of antibiotics without a doctor's prescription in response to escalating antibiotic resistance. DRAP CEO Asim Rauf highlighted the critical need for legislative changes, noting that accessing antibiotics in Pakistan is currently as easy as buying candy. Rauf also called for accountability for doctors who prescribe antibiotics indiscriminately and for pharmaceutical companies engaged in unethical marketing practices. With antibiotics worth Rs135 billion sold annually in Pakistan, addressing this issue is imperative. This call to action underscores the necessity for stricter regulations to combat antibiotic resistance, ensuring that these vital medications retain their effectiveness against harmful bacteria. By enforcing prescription requirements and promoting ethical practices, Pakistan can better safeguard public health and prevent antibiotic misuse. #pharmacist #industrialPharmacist #clinicalpharmacust #fda #WHO #DRAP #healthprofessionals

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    #AskYourDoctor&Pharmacist 1. Inquire about the prescribed medication: - Ask the doctor what physiological effects the prescribed medication will have and the mechanisms by which it operates. - Inquire if there is a risk that your body might perceive the medication as a threat and attempt to counteract its effects, potentially causing harm. 2. Understand potential side effects: - Request information on possible adverse effects that might occur with the medication and be vigilant for these symptoms. 3. Check for drug interactions: - Provide details about any other medications you are taking or have taken and ask if there might be any adverse interactions between these drugs. 4. Clarify dosage and administration: - Ask the doctor about the proper method, timing, and frequency of taking the medication. 5. Consult pharmacists or doctors with knowledge: - If the doctor cannot provide answers, consult a pharmacist. Avoid consulting doctors or pharmacists who lack information or sufficient time. Always seek clarity on medication use to prevent uninformed usage. #askyourdoctor #askyourpharmacist #letsconnect #shareknowledge #pharmacists #doctors

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    Collagen: An Essential Structural Protein Collagen is a crucial structural protein that maintains the integrity and elasticity of connective tissues in the human body, including skin, tendons, ligaments, and bones. It is the most abundant protein in mammals, comprising about 25-35% of total body protein content. Types of Collagen There are at least 28 different types of collagen, but the most common ones in the human body include: Type I: The most abundant, found in skin, tendons, and bones. It supports skin health and anti-aging. Type II: Found in cartilage, beneficial for joint health. Type III: Present in skin, muscles, and blood vessels, often used with Type I. Type V & X: Located in the cornea of the eye, hair, and the tissue between joints. Commonly included in multi-collagen supplements. Sources of Collagen Bovine (cow): Rich in Type I and III, ideal for skin, hair, nails, and joint health. Marine (fish): Primarily Type I, known for high bioavailability, making it effective for skin and anti-aging. Chicken: Rich in Type II, perfect for joint and cartilage support. Eggshell Membrane: Contains Type I, V, and X, beneficial for skin and joint health. Specific Health Goals For Skin Health: Marine collagen or bovine collagen Type I and III. For Joint Health: Chicken collagen Type II or multi-collagen blends including Type II. For Overall Wellness: Multi-collagen supplements that include a mix of different types. Bioavailability Look for hydrolyzed collagen or collagen peptides, as they are broken down into smaller peptides, making them easier for your body to absorb. Collagen in the Human Body Skin, Hair & Nails: Provides structure and elasticity. Bones and Teeth: Contributes to strength and flexibility. Tendons and Ligaments: Offers tensile strength. Cartilage: Maintains the integrity and function of joints. Collagen Supplements Collagen supplements are often derived from bovine, porcine, or marine sources and are available in various forms such as powders, capsules, and liquids. Best Times to Take Collagen Supplements On an Empty Stomach: Collagen is best absorbed in an acidic environment, so take it on an empty stomach in the morning. If you're intermittent fasting, take it right after the fasting period and allow some time before breakfast. Right Before Bedtime: Taking collagen before bedtime can be beneficial as the body repairs and regenerates during sleep. Post-Workout: Collagen can help with muscle recovery and joint health, reducing muscle soreness by enhancing blood flow and nutrient delivery. Boost its action by combining it with vitamin C, crucial for collagen synthesis. #pharmacist #clinicalpharmacist #pharmacyeducation #collagen #beauty #medicine #skin #hair #nails

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    #pharmaindustry #pharmaceuticalindustry ### HVAC qualification - # HVAC qualification - 🏅ISO 14644 [ clean room ] ### Cleaning validation - # Cleaning validation - 🏅WHO.TRS 1019 .annex 3 ### Machine qualification - # Machine qualification - 🏅ISO 8573-1 - 🏅WHO.TRS 986 .annex 2 - 🏅WHO.TRS 961. annex 9 ### Compressed air - # Compressed air - 🏅WHO .TRS 986 .annex 2 ### Thermal mapping - # Thermal mapping - 🏅WHO .TRS 961.annex 2 - 🏅WHO TRS 992 annex 5 [ WH - commissioning ] ### Supplier audits - # Supplier audits - 🏅USP 44 , general chapters - 🏅WHO .TRS 937.annex4 ### Automated system validation - # Automated system validation - 🏅WHO 961 .annex 7 - 🏅WHO 986 .annex 2 ### Personnel system - # Personnel system - 🏅WHO 986 .annex 2 - 🏅WHO 957 .annex 1 ### Premises - # Premises - 🏅WHO 957.annex 1 - 🏅WHO 986 .annex 2 ### Material management - # Material management - 🏅WHO 986.annex 2 - 🏅WHO 961.annex 1 ### Good practices in QC labs - # Good practices in QC labs - 🏅WHO 986 .annex 2 - 🏅WHO 957-2010 .annex 1 ### PQS - # PQS - 🏅WHO 986 .annex 2 - 🏅WHO 957 .annex 3 - 🏅WHO 986 .annex 1 ### Self inspection - # Self inspection - 🏅WHO 986 .annex 2 - 🏅WHO 957 .annex 1 - 🏅WHO 961- annex 2 ### Complaint system - # Complaint system - 🏅WHO 986 .annex 2 ### Recall system - # Recall system - 🏅WHO 986 .annex 2 ### Documentation system - # Documentation system - 🏅WHO 986 .annex 2 - 🏅WHO 957 .annex 1 ### Good production practices - # Good production practices - 🏅WHO 961.annex 5 ### Sampling process - # Sampling process - 🏅EUR .annex 8 - 🏅WHO TRS 986 - annex 2 - 🏅WHO TRS 929 - annex 4 ### Holding time study - # Holding time study - 🏅WHO TRS 992- 2015 - annex 4 - 🏅WHO TRS 1019 - annex 2 ### Pharmaceutical QC - # Pharmaceutical QC - 🏅 WHO TRS 1052 - annex 4 ### Sterile manufacturing - # Sterile manufacturing - 🏅Eudralex- annex 1 ### GMP basic principles - # GMP basic principles - 🏅Eudralex - 9 chapters ### Process validation - # Process validation - 🏅WHO TRS 1019 - annex 3 - 🏅WHO TRS 992 [ 2015 ] annex 3 - 🏅FDA guidance for industry - 🏅ISPE base line 5 - 🏅Eudralex - annex 15 - 🏅USP 905 ### APR - # APR - 🏅21CFR 211. 18e ### PQR - # PQR - 🏅Eu GMP . chapter 1 . volume 4 - 🏅PIC / S .chapter 1 ### GMP of hazardous materials - # GMP of hazardous materials - 🏅WHO TRS 957 - annex 3 ### Weighing area - # Weighing area - 🏅TRS 1019 - annex 2 ### GSDP - # GSDP - 🏅TRS 1025 - annex 7 ### CSV - # CSV - 🏅EU GMP - annex 11

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    **WHO's Progress on Global Trans Fat Elimination: A Milestone Report** The World Health Organization (WHO) has released its fifth milestone report on the global effort to eliminate industrial trans fat, covering the period from 2018 to 2023. As of 2023, 53 countries have implemented best practice policies to tackle trans fat in food. These policies have significantly improved the food environment for 3.7 billion people, or 46% of the world's population, and could potentially save around 183,000 lives annually. This is a substantial increase from just 6% coverage, affecting less than half a billion people, in 2018. Despite not fully meeting the ambitious target set by WHO in 2018 to eliminate trans fat from the global food supply by the end of 2023, remarkable progress has been made in every region of the world. In 2023 alone, new best practice policies were enacted in seven countries: Egypt, Mexico, Nigeria, North Macedonia, Philippines, the Republic of Moldova, and Ukraine. Additionally, in January 2024, WHO certified five countries for their progress in eliminating industrial trans fat: Denmark, Lithuania, Poland, Saudi Arabia, and Thailand. Dr. Francesco Branca, Director of the Department of Nutrition and Food Safety at WHO, emphasized the importance of monitoring and enforcing compliance with these policies to maximize and sustain the health benefits of trans fat elimination. "Trans fat elimination is attainable, affordable, and life-saving, and WHO remains committed to supporting Member States in their journeys towards this goal," said Dr. Branca. Despite the promising trends, progress has been uneven, leaving over 4 billion people globally unprotected from this harmful chemical, with the highest burden in the WHO African and Western Pacific Regions. Implementing best practice policies in just eight additional countries could eliminate 90% of the global deaths associated with trans fat consumption. The report recommends: - All countries enact best practice policies, particularly those with the highest remaining burden of disease due to trans fat intake. - Subregional bodies pass mandatory trans fat elimination policies. - Food manufacturers with high proportions of fats and oils comply with regulations and adopt healthier, alternative fats. Even in the absence of regulations, companies should proactively eliminate trans fat from their product lines and supply chains. To support these efforts, WHO has partnered with Resolve to Save Lives, a not-for-profit organization, to develop and implement the REPLACE action package. Launched in 2018, the REPLACE action package offers a strategic approach to eliminating industrial trans fat from national food supplies. Together, we can continue to make strides towards a healthier, trans fat-free world. #Health #TransFatElimination #WHO #PublicHealth #Nutrition #GlobalHealth #FoodSafety #PolicyImplementation

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