Hikma Pharmaceuticals’ Post

"Setting benchmarks in IV manufacturing with FDA-compliant APIs and primary packaging excellence. #OtsukaPakistan #IVManufacturing #QualityFirst" "Where aseptic precision meets global standards, ensuring unmatched IV solutions. #FDAApproved #PharmaExcellence" "Delivering quality IV therapies with robust compliance and cutting-edge technology. #HealthcareInnovation #OtsukaStandards" "Otsuka Pakistan: Redefining IV manufacturing with world-class materials and processes. #IVSolutions #GlobalCompliance" "Leading with innovation and integrity in IV fluid production for better healthcare outcomes. #PharmaLeadership #QualityMatters"

Australia has updated standards for unapproved therapeutic vapes, covering ingredients, packaging, and technical rules to reduce health risks. Importers and manufacturers have notified the TGA of compliance. Both current and new standards apply until March 2025, with stricter standards fully enforced by July 2025, limiting import, manufacture, and supply to compliant products only. https://lnkd.in/drkMu3hi #AustraliaRegulations #VapingStandards #TherapeuticVapes #HealthCompliance #TGA #ProductSafety #VapeIndustry #SmokingCessation #NicotineManagement #HealthStandards

𝐔𝐧𝐥𝐨𝐜𝐤𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐮𝐥𝐥 𝐏𝐨𝐭𝐞𝐧𝐭𝐢𝐚𝐥 𝐨𝐟 𝐘𝐨𝐮𝐫 𝐇𝐞𝐚𝐥𝐭𝐡 𝐒𝐮𝐩𝐩𝐥𝐞𝐦𝐞𝐧𝐭 𝐢𝐧 𝐌𝐚𝐥𝐚𝐲𝐬𝐢𝐚 Ensuring compliance with NPRA regulations is key to registering your health supplement in Malaysia. The NPRA ensures product safety and quality, and their detailed guidelines can help you through the process; 𝗔𝗽𝗽𝗲𝗻𝗱𝗶𝘅 6: 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲 𝗼𝗻 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵 𝗦𝘂𝗽𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝘀 ⁉️ Did you know the NPRA has stringent limitations on what health claims supplement companies can make? This could mean your amazing product's true potential might be downplayed. NPRA approval is a rigorous process, but it guarantees that consumers receive a product with substantiated claims. This builds consumer confidence and opens doors to a wider market. Let's leverage our NPRA expertise to streamline the process and secure swift approval for your supplement. Imagine your winning formula reaching health-conscious Malaysians! Novavita is just one call away! 🔔 #NPRA #MOH #regulatoryaffairs #regulatoryupdate #guidelines #regulations #malaysia #standard #international #consultant #cosmetics #beauty #drugs #pharmaceuticals #healthsupplement https://lnkd.in/gz5CTies

The Saudi Food and Drug Administration (SFDA) published the guide to Good Manufacturing Practice for Natural Health Products. Country: Saudi Arabia #HealthcareInnovation #publishing #manufacturing #HealthAndWellness #Medical #regulatoryaffairs #sfda #healthcare #healthproducts #KSA

Health Canada just released its draft Good Manufacturing Practices (GMP) guidance for Natural Health Products (NHPs) – the first update since 2015! 💥 Many of the new points outlined were raised in our recent Quality IMPORT Solutions site license renewal and inspection so we got a teaser last September (I prefer movie teasers than this!). 📝 Key Changes: 1️⃣ Focus on Quality Systems: The draft introduces a strong focus on Quality Management Systems (QMS), similar to those found in drug, medical device, and cannabis sectors. 2️⃣ Record Keeping & Traceability: Expect more detailed documentation and stronger emphasis on ingredient and product traceability. 📑 3️⃣ Testing & Stability: The draft elaborates on skip lot testing, composite testing, and more. Health Canada’s inspections have already highlighted these areas as crucial, so no surprise they're major in the new guidance. 🔬 4️⃣ Expanded Recognized Authorities: Beyond MRA, the draft now includes PIC/S, broadening international equivalency in GMP inspections 🌍. 5️⃣ Ingredient & Supplier Verification: With a focus on importers, expect more scrutiny on verifying foreign sites' GMP compliance. 🔍 6️⃣ Internal Audits & Continuous Improvement: Regular internal audits and improvements are essential, especially for importers with foreign site licenses. 🔄 If you hold a site license and haven’t been audited yet, this draft will be invaluable in preparing you for what's to come! ✅ 🗓️ Consultation runs from October 15 to December 16, 2024. Don’t miss your chance to weigh in! Read more here: https://lnkd.in/gTXQKW2s #HealthCanada #GMP #NaturalHealthProducts #Compliance #Regulatory #NHP #QualityManagement #Traceability #SiteLicense

𝑺𝒕𝒓𝒖𝒈𝒈𝒍𝒊𝒏𝒈 𝒘𝒊𝒕𝒉 𝑹𝒆𝒈𝒖𝒍𝒂𝒕𝒐𝒓𝒚 𝑪𝒐𝒎𝒑𝒍𝒊𝒂𝒏𝒄𝒆 𝒇𝒐𝒓 𝑷𝒂𝒓𝒆𝒏𝒕𝒆𝒓𝒂𝒍 𝑷𝒂𝒄𝒌𝒂𝒈𝒊𝒏𝒈 𝒊𝒏 𝑴𝑬𝑵𝑨/𝑮𝑪𝑪? Meeting regulatory standards in the MENA and GCC regions can be complex, especially when it comes to parenteral packaging. With varying requirements across countries, ensuring compliance is essential to getting your product to market safely and efficiently. At 𝐏𝐡𝐚𝐫𝐦𝐓𝐞𝐜𝐡 𝐄𝐔, we’re here to make compliance straightforward. Our team specializes in navigating regional regulations for parenteral packaging, covering everything from material selection and sterility to traceability and labeling. We help companies stay on top of evolving standards while focusing on what matters most—quality and innovation. 💼 𝑵𝒆𝒆𝒅 𝒈𝒖𝒊𝒅𝒂𝒏𝒄𝒆 𝒐𝒏 𝒎𝒆𝒆𝒕𝒊𝒏𝒈 𝒓𝒆𝒈𝒖𝒍𝒂𝒕𝒐𝒓𝒚 𝒔𝒕𝒂𝒏𝒅𝒂𝒓𝒅𝒔? 𝑪𝒐𝒏𝒕𝒂𝒄𝒕 𝑷𝒉𝒂𝒓𝒎𝑻𝒆𝒄𝒉 𝑬𝑼 𝒆𝒙𝒑𝒆𝒓𝒕𝒔 𝒕𝒐 𝒅𝒊𝒔𝒄𝒖𝒔𝒔 𝒉𝒐𝒘 𝒘𝒆 𝒄𝒂𝒏 𝒔𝒖𝒑𝒑𝒐𝒓𝒕 𝒚𝒐𝒖𝒓 𝒄𝒐𝒎𝒑𝒍𝒊𝒂𝒏𝒄𝒆 𝒋𝒐𝒖𝒓𝒏𝒆𝒚. #RegulatoryCompliance #ParenteralPackaging #PharmTechEU #Tofflon

EDA Published a new step to combat bacterial resistance, the Egyptian Drug Authority issues the eighth national guide to rationalize the use of antimicrobials https://lnkd.in/eHuZ7-_w #HealthcareInnovation #publishing #declaration #manufacturing #healthandwellnesss #regulatoryaffairs #EDA #healthproducts #eygpt #consultations

We are pleased to be certified by Fedegari Group as an official Authorized Service Provider in Australia & New Zealand. As a Fedegari Customer Care service provider for over 25 years, this new certification recognises our reliability and expertise in installation, IQ, OQ, PQ, SAT tests, commissioning and ongoing maintenance. Why choose a Fedegari Authorized Service Provider?  🔹 Exclusive Network: only the best professionals, certified by Fedegari, properly take care of the installed fleet.  🔹 Highly Qualified Technicians: trained to ensure flawless interventions according to latest good maintenance practices.  🔹 Collaboration and transparency: a constant exchange of information between the network and Fedegari ensures efficiency and in-depth knowledge of the installed fleet.  🔹 Lifetime support: Fedegari's responsibility and commitment remain active throughout the machine's life cycle, offering unparalleled support. Choosing PharmEquip and Fedegari means choosing safety and quality without compromise. 🌟 #TechnicalSupport #Sterilization #Quality #Excellence #Innovation

🇲🇾 On October 8, 2024, #Malaysia's Ministry of Health (MOH) announced the approval of the natural product Nova Hepar-P Capsule with a modern claim for liver health support. This marks the first registration of a natural product with a modern claim, following the country's policy change in April 2024. Please check the following article for more details. #naturalproduct #claims #regulation #regulatorycompliance

The transport of medicines is crucial to ensure that these products arrive in optimal conditions and fulfill their purpose without compromising their efficacy. Did you know that there is a specific regulation governing this process? Royal Decree 782/2013, of October 11, on the distribution of medicines for human use, establishes a series of key points that must be taken into account: ➡ Temperature and humidity: medicines must be transported under specific conditions to ensure that their properties are not altered. It is necessary to have continuous monitoring and recording systems for these parameters. ➡ Vehicles and equipment: vehicles and equipment used in transportation should be designed in such a way as to ensure the protection of the drugs from adverse conditions of temperature, humidity, light, etc., and they should be clean and disinfected to avoid contamination. #Logistics #InternationalTrade #Export #Import #MaritimeTransport