Zelmic AB’s Post

IS GMP ENOUGH FOR MAKE SURE KRATOM PRODUCT IS SAFETY TO CONSUME? THE ANSWER IS NO!! check this out!! tell me your opinion, lets talk about #GmpcertifiedKratom https://lnkd.in/gutqiAdE #kratom #kratomsaves #kratomsaveslife #mitragynaspeciosa #usa #kratomusa #kratomcanada #kratomczech #kratomindonesia

🎥 Behind the Scenes at Nedcann: Ensuring EU GMP Compliance 🎥 When a partner's friend requested to do a video shoot for her music video at our Nedcann facility, it sounded straightforward at first. However, ensuring compliance with EU GMP (Good Manufacturing Practice) standards is no simple task. Our Quality Team quickly got to work: 1. Initial Risk Analysis: We reviewed our SOPs (Standard Operating Procedures) and provided the video team with clear guidelines. This included disinfecting equipment, as well as training the crew on proper behavior in a GMP area. To them the process was far more complex than anticipated, but still they wanted to get it done. 2. Script Review and Special Requests: Upon receiving the script, we identified several requests that extended beyond our boundaries. At first, we thought it would not be possible and considered rejecting the project due to the request to film with less protection. Then, our Q-Team came up with a second risk analysis and solutions to make it work. 3. Second Risk Analysis: We established strict protocols including maintaining a 1.5m distance from products, disinfecting everything that was touched, clearly mapping entry and no-go areas, and destroying any potentially contaminated products. It led to significant quantity flower destroyed and nearly 2 liters of isopropanol used for disinfecting, and still, we are proud to have found a solution that worked, allowing the video shoot to proceed while maintaining our rigorous standards. This experience highlighted the meticulous efforts required to ensure a safe and clean product in a GMP-compliant facility. Witnessing what is necessary to uphold these standards reaffirms our commitment to excellence in every aspect of our operations. #GMPCompliance #MedicinalCannabis #QualityAssurance #Nedcann #InnovationInAction #BehindTheScenes #PharmaceuticalExcellence

🎥 Behind the Scenes at Nedcann: Ensuring EU GMP Compliance 🎥 When a partner's friend requested to do a video shoot for her music video at our Nedcann facility, it sounded straightforward at first. However, ensuring compliance with EU GMP (Good Manufacturing Practice) standards is no simple task. Our Quality Team quickly got to work: 1. Initial Risk Analysis: We reviewed our SOPs (Standard Operating Procedures) and provided the video team with clear guidelines. This included disinfecting equipment, as well as training the crew on proper behavior in a GMP area. To them the process was far more complex than anticipated, but still they wanted to get it done. 2. Script Review and Special Requests: Upon receiving the script, we identified several requests that extended beyond our boundaries. At first, we thought it would not be possible and considered rejecting the project due to the request to film with less protection. Then, our Q-Team came up with a second risk analysis and solutions to make it work. 3. Second Risk Analysis: We established strict protocols including maintaining a 1.5m distance from products, disinfecting everything that was touched, clearly mapping entry and no-go areas, and destroying any potentially contaminated products. It led to significant quantity flower destroyed and nearly 2 liters of isopropanol used for disinfecting, and still, we are proud to have found a solution that worked, allowing the video shoot to proceed while maintaining our rigorous standards. This experience highlighted the meticulous efforts required to ensure a safe and clean product in a GMP-compliant facility. Witnessing what is necessary to uphold these standards reaffirms our commitment to excellence in every aspect of our operations. #GMPCompliance #MedicinalCannabis #QualityAssurance #Nedcann #InnovationInAction #BehindTheScenes #PharmaceuticalExcellence

If Cleaning is your topic, join my presentation during the 25th and 26th of October in Berlin. Cleaning and the possibility of cross contamination in shared facilities is of high concern from the gmp regulatory authorities. During my presentation I‘ll explain how you can quantify clean on different surfaces to extremely low levels. Thanks to Igor Kuzmenko for organizing this Conference. As always yours Richard Denk SKAN #VLCleanValidation #VLHPAPI #gmp #contaminationcontrol #pharmaindustry #cleaning #cleaningvalidation #richarddenk #skan

End of day one of the Lincoln Health Network QA Maters 101 course! Today we went over the basics of a QMS, best practices and some real world examples from FDA 483s and Warning Letters. Tomorrow we dive into investigations, CAPAs, risk assessments and FMEA group work! Join us next month for our NEW QA Masters 201 class where we discover why the Titanic REALLY sank and what the COPQ was! How would an FMEA exercise have helped save lives? Our training course is always super fun, interactive and a safe space to discuss common QA challenges and the best resolutions. In summary, Quality ROCKS! #pharmaceuticalindustry #medicaldevices #capa #qualityassurance #qualitymanagementsystem #cannabis #compoundingpharmacy #503b #pharmacist #cpht #qualitycontrol #qualitymatters #continuingeducation #continuousimprovement

Connect with real experts who care. At GMP, meet a team that’s as invested in your success as you are.

Here at Nemera, quality is at the forefront of what we do ⭐ ✅ Our operations comply to standards established by external health authorities and international harmonisation organisations. Compliance to these standards helps us ensure product safety and quality. ✅ Along with GMP conformity, International Standardisation Organisations also provide ISO guidelines for drug delivery device solution manufacturers like Nemera. ✅ Our Quality Management System (QMS) adheres to the ISO standards in place for medical devices, cleanrooms, primary packaging, environmental and energy management to name a few. For more information, check out our website. Link in the comments 🔗 #puttingpatientsfirst

Just Finished the course "Introduction to GMP Annex 1" from Pharmuni ! Very useful information about Sterility production requirements for EU registration ,Room cleanliness degrees and its characterizations and how to develop a CCS (Contamination Control Strategy)

Good Manufacturing Practices, or GMPs, have existed for over a century. While it might seem overwhelming, consultants like Kimberly Stuck, CP-FS, CQA at Allay Consulting LLC are experts at breaking the process down and preparing you for an audit. Reminder - the Qredible Broadcast is on hiatus for the holidays, but stay tuned. We have an incredible lineup ready for you for 2024! #GMP #cannabisindustry #qrediblebroadcast