Implementing GMPs in supplement manufacturing can increase production costs due to the need for proper facilities, qualified personnel, and validated processes. https://lnkd.in/d757rS7X
NUTRACEUTICALS FACTORY的动态
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Regulatory Affairs Team Lead - KIMTECH/KLEENGARD Business Unit @ Ansell | PhD in Vascular Biology | Driven, strategic leader and RA professional
This is a great read. It highlights the need for successful FDA enegaements, it goes beyond a regulatory matter - it’s cross-functional. This is where I feel internal audits, mock audits, etc. bring tremendous value to an organization. Establishing plans and building capability is key. #RAPS #MedicalDevice #FDA #regulatoryaffairs #qualityaffairs
Inspectors at FDA say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during inspections of manufacturers, according to FDA official who spoke at the Orange County Regulatory Affairs Discussion Group annual conference last week. Jeff Craven reports in Regulatory Focus ?? ?? https://bit.ly/4fBDQz5
Data integrity is ‘biggest issue' for drug, API firms during inspections, FDA official says
raps.org
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Responding to an FDA Form 483 or FDA Warning Letter It’s a moment any business involved in manufacturing and production dreads. The Food and Drug Administration (FDA) has completed an inspection of your facilities, and just when you thought everything was wrapped up smoothly, the FDA inspector notifies company management that your organization will be issued an FDA Form 483. What is an FDA Form 483, and what does that mean for your company? Today, we’re going to discuss the details of FDA Form 483, and give you actionable advice on how to respond to one. https://lnkd.in/g5xDsKiE #FDAForm483 #FDA #FoodSafety #FoodandBeverage #Manufacturing #ManufacturingConsultants
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A “Cliff’s Notes” version, to go with many other notes about how to implement ISO 13585 plus for LDTs.
The FDA has published a final guidance aimed at small entities that produce laboratory-developed tests. The agency published a final rule in April stating that it will phase out its regulatory discretion for LDTs, and the new guidance only solidifies that position but is much more concise. Ferdous Al-Faruque reports for Regulatory Focus: https://bit.ly/4bofh5o
FDA publishes LDT rule ‘CliffsNotes' in guidance for small companies
raps.org
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Stop by booth 415 at the RAPS conference to see how #OneMMS can help with your data integrity and inspection readiness needs.
Inspectors at FDA say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during inspections of manufacturers, according to FDA official who spoke at the Orange County Regulatory Affairs Discussion Group annual conference last week. Jeff Craven reports in Regulatory Focus ?? ?? https://bit.ly/4fBDQz5
Data integrity is ‘biggest issue' for drug, API firms during inspections, FDA official says
raps.org
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Marketing Head @ Mettler Toledo || Marketing Strategy || B2B Marketing || Digital Transformation || Branding || Customer Engagement || Influencer
??Fill control, check weighing and weight variation are widely applied ??statistical quality control techniques that use the weight of the individual goods in the statistical analysis. #Statistical #qualitycontrol techniques are vital for monitoring the inherent variations that are present in all #manufacturing processes. These variations may be due to the raw materials, the uniformity of the product components, filling machines, techniques used, and the ??packaging process. #mettlertoledo.
#Pharma |#SQC techniques are widely applied for fill control, check weighing, and assessing weight variation to ensure consumer safety and ?#compliance, especially in the ??#PharmaIndustry. Download our application note to speed up your SQC workflow? https://okt.to/gxJBYp
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Senior Sales Engineer| Mettler Toledo India Private Limited | Laboratory Balances and Analytical Equipments
How about a solution that could help you check fill control and assess weight variation to ensure consumer safety. Check our solution for SQC using Analytical Balance and LV12 to guarantee Quality control over your products. Click on the link to view more! #SQC #Consumersafety #weightassess #fillcontrol #mettlertoledo
#Pharma |#SQC techniques are widely applied for fill control, check weighing, and assessing weight variation to ensure consumer safety and ?#compliance, especially in the ??#PharmaIndustry. Download our application note to speed up your SQC workflow? https://okt.to/gxJBYp
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Compliance and Audit Trail Electronic signatures facilitate compliance with regulatory requirements by providing an extensive audit trail. Every transaction and interaction related to the prescription can be documented and tracked, ensuring adherence to the controlled substance regulations and facilitating audits when necessary. https://lnkd.in/dn2cZWRW #TechnologyInHealthcare #SupplyChainControl #ElectronicSignatures #PatientSafety #PainManagement #ControlledMedications #EgyptPharmacy #EGYDRUG #MinisterialDecree170 #Law184of1960 #EDAApprovals #PharmacyAutomation #PrescriptionProcess #Schedule1Medications #MedicationSupplyChain #EgyptHealthcare #PatientSafety #PharmaceuticalRegulations #HealthcareTechnology #DigitalHealthcare #PharmacyCompliance #MedicationSecurity #PrescriptionManagement #PharmaceuticalDistribution
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We are thrilled to have our very own Pallavi Devurkar-Badkar sharing her insights on successes and challenges of a developing 503B industry at the FDA Compounding Quality Center of Excellence 2024 Annual Conference. Learn more about regulatory challenges, best practices and quality standards in the constantly evolving industry. Registration link : https://lnkd.in/eFYYDYDD #503Bpharmacy #MedisourceRx #panelist #FDA2024 #FDAAnnual2024
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Consultant specializing in Quality Systems, GMP and Regulatory Affairs | Adjunct Professor| Keynote Speaker
?? Exciting Announcement ?? In the ever-evolving landscape of regulatory compliance, staying ahead is key. ??? ?? Are you prepared to crusch your next FDA inspection? ?? In the upcoming days, we will dive into the crucial topic of utilizing industry data to fortify your company's readiness for an FDA inspection. ???? Stay tuned for insights, strategies, and tips to navigate the intricacies of compliance seamlessly. Let's empower our teams to not just meet, but exceed regulatory expectations. ?????? #FDAInspection #RegulatoryCompliance #Pharma #quality #FDAlytics
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