Health Sciences Authority’s Post

I am thrilled to post our latest OCT work in collaboration with FDA. Thanks to Maxwell Korang-Yeboah, Xin Feng and Huiquan Wu at FDA for great technical support and guidance. A great step forward in process monitoring and control of sensitive coating operations! #FDA #quality #OCT #process control Here is the link:

The platinum group elements (PGEs) play an important role in reducing emissions from automotive vehicles through their use in catalytic convertors but also for catalysis in the pharmaceutical industry. Due to their immense economic value, accurate measurement is crucial. We coordinated an international comparison study (CCQM) with other National Metrology Institutes (NMIs) and Designated Institutes (DIs) to demonstrate #measurement capability of platinum, palladium and rhodium. Our methodology was #published earlier this year and gained ISO/IEC 17025 accreditation - https://okt.to/yrR5S1 (ISO accreditation is held by LGC) Read more about the CCQM-K160 study-https://okt.to/vVc91z #CCQM #Metrology #referencematerials Bureau International des Poids et Mesures (BIPM)

First day at Cell UK and some trending challenges highlighted in the regulatory stream. High on the list - timely procurement of GMP reagents and with that, transfer from RUO to GMP. It’s a good idea to query early if there actually is a GMP version available for your reagent, identify partners who are developing products with easy transfer to GMP and scale in mind, and work with them to plan ahead on supply needs. Something to spend time on at the early stages to save on pain later. #celluk #cellandgenetherapy

Certain thresholds and limits are taken into consideration when selecting machinery or technology for the production floor to determine the risk level of pharmaceutical molecules. These include OEL, NOEL, OEB, and STEL. OEL that means Occupational Exposure Limits are highly counted by Pharmaceutical companies as it’s measure the mass of pharma molecules in a specific volume of surrounding air for a certain exposure time and usually it considered as µg/m3 over 8 hour time weighted average (TWA). In this level, an operator may exposed and his health is risk free. NOEL or No Observable Effect Level is the daily dose applied to a person as mg/kg bodyweight and increased to a level till adverse reaction found. It’s measured to reach OEL. OEB stands for Operational Exposure Band. It’s also called ‘Hazard group’, which has 6 bands or A to F bands. For example, OEB 4 or D means OEB level 10-1 µg/m3 and OEB 5 or E means OEB level 1-0.01 µg/m3, OEB 6 or F means OEB level <0.01µg/m3. It seen OEB level differs 10 fold during conversion from one band to next band. Short term Exposure Limit or STEL. It can be given as an example, suppose a worker need 3 milling operations in 8 hour shift, where 15 minutes takes to complete each milling and for each milling considered 1 µg/m3 is STEL. This STEL is defines to exposure of 1µg/m3 x 3 tasks x (0.25hr/8hrs) x 10% = 0.0094 µg/m3 TWA of 8 hours. #pharmaceutical #pharma #pharmaceuticalindustry #randd #productionprocess #oel #oeb #noel #production #operation #operatorrisk #pharmamachine #machinematerials #material #PharmaceuticalManufacturing #Manufacturing #pharmagrade #PharmaceuticalProducts #GoodManufacturingPractices #GMP #oem #pharmaengineering #engineering

🚨 Rouge in Pharmaceutical Water Systems: A Silent Threat Pharmaceutical water systems are critical for maintaining the highest standards of GMP compliance. However, rouge, caused by corrosion in stainless steel piping, poses risks to product quality and patient safety. 📊 Why Monitor Rouge? Ensures product purity ✅ Extends equipment lifespan 🔧 Meets regulatory compliance 📜 🔍 How HPLG Technology Revolutionizes Rouge Monitoring HPLG (High-Pressure Liquid Chromatography) is a game-changer in detecting rouge in water systems: 1️⃣ High Sensitivity: Detects even trace levels of corrosion products. 2️⃣ Non-Destructive: Monitors without disrupting operations. 3️⃣ Regulatory Compliance: Supports precise reporting for audits. 🌟 Best Practices for Implementing Rouge Monitoring Regular Testing: Schedule periodic HPLG analyses. Preventive Maintenance: Use HPLG data to optimize system cleaning and passivation. Documentation: Maintain detailed records to align with ALCOA+ principles. 💡 Staying ahead in pharmaceutical compliance requires adopting innovative solutions like HPLG for rouge monitoring. Protect your water systems, products, and patients. 📢 Join the Conversation! What strategies are you using to monitor rouge in your water systems? Let’s discuss in the comments below! #PharmaceuticalWater #RougeMonitoring #HPLG #PharmaCompliance #GMP

High efficiency air filters (EPA, HEPA and ULPA)⏭️ This European Standard applies to high efficiency particulate and ultra low penetration air filters (EPA, HEPA and ULPA) used in the field of ventilation and air conditioning and for technical processes, e.g. for applications in clean room technology or pharmaceutical industry. It establishes a procedure for the determination of the efficiency on the basis of a particle counting method using a liquid (or alternatively a solid) test aerosol, and allows a standardized classification of these filters in terms of their efficiency, both local and integral efficiency. #HEPA #EPA #ULPA #Filters #Pharmaceuticals_Clean_Rooms #Clean_Rooms #Pharmaceuticals #Bangladesh_Pharmaceuticals #Manufacturing #QO #QC #Production #QA #Regulatory #GMP

Between 2011 and 2021, 188 endotoxin-related FDA Form 483s were issued to drug and device manufacturers. The FDA requires that endotoxin testing is performed for API and raw materials, container closure equipment, process intermediates, finished drug product, devices, and manufacturing equipment. Furthermore, the product must be validated to demonstrate that the product and matrix do not interfere with the endotoxin test. The Hyde Analytical Laboratory has introduced routine endotoxin, TOC, and HPLC analysis to help our clients reduce QC testing bottlenecks, making it easy to establish routine testing protocols that are compliant, risk-based, and put the patient first. Get to know our lab and reach out to an expert!: https://lnkd.in/gxG4yGri Michael Lund Nicole Collier Linda Long Keith Bader John Hyde #hydeanalyticallaboratory #endotoxin #qualitycontrol #483 #laboratory #cleaningvalidation #drugsafety

ICH quality guideline update Further to the ICH Management Committee’s endorsement of the Q1/Q5C Concept Paper and Business Plan in November 2022, the Q1/Q5C EWG was established to revise the current ICH Stability Guideline Series Q1A-F and Q5C. This is being done to streamline the series, combining the various guidelines into a single guideline focused on core stability principles and also to promote harmonised interpretation by addressing potential gaps and areas of ambiguity. The idea is to also include new topics, such as stability considerations for advanced therapies. The end result could be a combined guideline; ICH Q1, with integrated annexes and/or appendices that address specific topics beyond the core stability recommendations and principles. Addressing drug product types including substances, intermediates, and devices. Once implemented, it will streamline lot of quality work

Take a quick look at how engineering sites are starting to see the benefits of Asset Mate's preventative maintenance system. If you would like to know more, don't hesitate to reach out! #AssetMate #AssetManagement

VALIDATION - Enzyme/Clean booths AFMS offers Validation and certification of Enzyme/Clean booth in accordance with ISO14644:1 and manufacturers' requirements. These standards and guidelines play a crucial role in ensuring a sterile environment and protection of products. Enzyme/ Clean booth is commonly used in laboratories, pharmaceutical facilities, and other environments where a sterile and particle-free workspace is essential. The booth uses clean HEP filtered air to create a clean and controlled environment, preventing the contamination of sensitive materials or experiments. AFMS Testing of the clean booth involves various procedures to ensure their proper functioning and compliance with cleanliness standards. Here are some aspects of testing offered by AFMS: AIRBORNE PARTICLE COUNTING: Regular monitoring of airborne particles within the clean bench is essential. Particle counters are used to measure the concentration of particles in the air and verify that it meets the specified cleanliness class. Visit our website to find out more: https://www.afms.bz Contact Us: Call: +2711 462 0120 | +2781 111 2367(SA) Email: afms@afms.bz #laboratorylife #laboratory #laboratoryequipment #biosafety #biologicalsafety