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“Africa Strategy for Pharmaceutical Traceability” Part 2 Nigeria - NAFDAC aims for full pharmaceutical traceability by 2024, adopting global standards to enhance supply chain visibility and combat falsified medicines #serialization #SerializationConsulting #pharma #pharmaceutical #trackandtrace #supplychain #Cosmotrace #support #alertmanagement #projectmanagement #technicalconsulting #consulting #partneronboarding #Onboarding #data #datagovernance #validation #testing #operations #vendor #assessment #compliance #partners #systemvalidation #africa #Nigeria https://hubs.ly/Q02xx8Pr0

Permitted Daily Exposure Limits (PDEs) are set for Active Pharmaceutical Ingredients (APIs) to control cross-contamination when manufacturing medicinal products in shared facilities. With the lack of official PDE lists for pharmaceuticals, PDEs have to be set by each company separately. In this recent paper, the Permitted Daily Exposure of 5 Active Pharmaceutical Ingredients from different pharmaceutical companies were collected and compared, showing a robust methodology in the PDE derivation https://lnkd.in/egp6HXGx Need for a PDE? At S&C BEST we can support you in the API evaluation and PDE derivation #PDE #API #Toxicology

#Pharmaceutical Microbiological #Testing, we help pharmaceutical manufacturers ensure quality, safety and the efficacy in their products 💊 🔬 🧫 The pharmaceutical division of Microchem is a South African Health Products Regulatory Authority (SAHPRA) approved contract #laboratory that specialises in the #microbiological analysis of pharmaceutical products and ingredients. As part of our provision of the service we conform to current Good Manufacturing Practices (#GMP). 👉 https://lnkd.in/dY6a64wa Microbiological testing plays an important role in the production of pharmaceutical drug formulations. Pharmaceutical microbiological testing ensures that raw materials used in manufacturing match the standard quality requirements before they are processed in the production environment. Whether you need to determine #sterility, preservative efficacy, #microbial limits, absence of objectionable organisms, detect #endotoxins, or determine environmental monitoring processes efficacy, we can assist you. #microbiologicalanalysis #pharmaceuticalproducts #microbiology #microbiologicaltesting #microbiologicaltesting #pharmaceuticaltesting #bioburden #GoodManufacturingPractices #pharmaceuticalindustry

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🔬 Worried about nitrosamine contamination in your products? We provide GMP-certified and FDA-registered analytical services for the precise detection and quantification of nitrosamines in pharmaceutical products, in full compliance with ICH M7 guidelines. 🚨 Why test for Nitrosamines? Nitrosamines are genotoxic and potentially carcinogenic. It's crucial to ensure your products are safe for patients, with strict limits for nitrosamine levels set by regulatory bodies worldwide. 🔍 Our Services Include: ✅ Advanced Testing: LC-MS/MS and GC-MS for accurate results ✅ Risk Assessment: Identify potential sources of contamination ✅ Regulatory Compliance: We meet ICH M7 guidelines and GMP standards 📞 Contact us today to learn more about how we can support your nitrosamine testing needs! #NitrosamineTesting #PharmaceuticalSafety #GMP #ICHM7 #RegulatoryCompliance #Pharma #LabServices #QualityControl #Tentamus

#Pharmaceutical Microbiological #Testing, we help pharmaceutical manufacturers ensure quality, safety and the efficacy in their products 💊 🔬 🧫 The pharmaceutical division of Microchem is a South African Health Products Regulatory Authority (SAHPRA) approved contract #laboratory that specialises in the #microbiological analysis of pharmaceutical products and ingredients. As part of our provision of the service we conform to current Good Manufacturing Practices (#GMP). 👉 https://lnkd.in/dY6a64wa Microbiological testing plays an important role in the production of pharmaceutical drug formulations. Pharmaceutical microbiological testing ensures that raw materials used in manufacturing match the standard quality requirements before they are processed in the production environment. Whether you need to determine #sterility, preservative efficacy, #microbial limits, absence of objectionable organisms, detect #endotoxins, or determine environmental monitoring processes efficacy, we can assist you. #microbiologicalanalysis #pharmaceuticalproducts #pharmaceuticalingredients #microbiology #microbiologicaltesting #microbiologicaltesting #pharmaceuticaltesting #bioburden #GoodManufacturingPractices #pharmaceuticalindustry Nathan Naudé Hannes Esterhuizen Charl Bekker Luaan Louw Ilse Liedemann Anastasia Stemmers Rogan Van Kerpel Ryno van Eck Stephen Newborn Raeesa Dawood (MBA)

In an industry where safety, efficacy, and compliance are paramount, precision in Certificates of Analysis is non-negotiable. #COA documents are more than a formality—they are the foundation of trust, regulatory compliance, and quality assurance in pharmaceutical manufacturing. #USpharma #PharmaIndustry

In today's complex pharmaceutical landscape, maintaining rigorous quality standards is non-negotiable. A recent FDA warning letter to a US pharmaceutical company highlights serious lapses in supplier qualification and oversight. The inspection, prompted by issues at the company's CMO, revealed inadequate procedures to ensure compliance with CGMP and to guarantee the quality of drug products. Now, the company must reassess its supplier and CMO qualification program, including implementing a plan for periodic audits. The FDA stressed that the company is ultimately responsible for drug quality, regardless of any agreements with CMOs. At #Cefea, we take these responsibilities seriously, with our quality processes and procedures consistently meeting the highest standards, as demonstrated by the numerous audits conducted by our international clients. #GMP #industry #qualityassurance #compliance #Cefea #clinicalsupply Read more: https://lnkd.in/gNiMcKE3