PDA - Parenteral Drug Association’s Post

REVISED ANNEX 1 (Manufacture Of Sterile Medicinal Products) This document provides guidance for ensuring sterility in the manufacture of sterile medicinal products through a contamination control strategy (CCS). The CCS should establish robust assurance of contamination prevention from microbial, endotoxin/pyrogen and particulate sources. It involves identifying risks to product quality using quality risk management and putting in place controls like facility design, equipment qualification, environmental monitoring, personnel training and change control to minimize these risks. The CCS must describe all elements of the manufacturing process and be reviewed periodically for effectiveness in assuring sterility of the final product. Credit to #PICS #gmp #EMA #annex1 #validation

ℹ Let’s take a look at what some of our #attendees have said about the previous Cleaning Validation in Pharma online training course. This 3-day #training covers a systematic evaluation and understanding of Cleaning validation regulations, risk reduction, and GMP requirements, focusing on the development of Cleaning validation protocol, Method Validation, Sampling techniques, and Recovery Studies. The #next live online training course will be on 11 – 13 March 2024 🗓 #cleaningvalidation #survey #GMPcompliance #SymmetricTraining

📢 Take a look at our latest blog post: "QC Labs - The Three Ways Our New Compliance Package Can Help". Discover how our PURELAB® Pharma Compliance package provides a tailored, easy-to-use combination of equipment and services to ensure a reliable supply of ultrapure water for quality control (QC) laboratory processes. Read more: https://lnkd.in/edpUYuNW ⚙️ Our intuitive software ensures seamless integration of the PURELAB® equipment into your lab, with no disruption to water supply or quality. It meets global regulators' best practices for data management and provides evidence for FDA and EU standards. 📝 We offer different levels of purified water validation, from water dispenser systems to GLP validation and FDA 21 CFR part 11 compliance. Installation Qualification (IQ) and Operational Qualification (OQ) documents are included in the package. #ultrapurewater #QClabs #waterpurity #compliance

What suitable environmental monitoring is required to meet the requirements of #ISO and the regulatory bodies? Join the discussion with Mark Hallworth, the Global Pharma GMP Advisor for Particle Measuring Systems. Mark will review how the standards and regulations promote a cohesive environmental program and we will look at manual compounding in laminar flow hoods, through to filling lines, both open and closed systems. Learn more and register here: https://lnkd.in/eK6pkFmA Can't make it? No worries! When you register for the webinar, you will receive a recording of the discussion so you can watch it at any time. #environmentalmonitoring #pharmaceuticalmanufacturing #gmp #isostandards #aseptic #asepticprocessing #asepticfilling Learn more and register here: https://lnkd.in/eK6pkFmA

📚 GMP compliancy is a must for our clients and for us! Yes, it’s a lot of work to follow all the rules and regulations to a T, but at TRU, we don’t consider this a burden at all. In fact, it’s a way of working that has incredible added value. 🎯 So, considering our day-to-day involvement in GMP compliancy, we thought it would be great to organize an event on the topic: 🎉 GMP Insights. 🎉 If you’re curious about GMP regulations or if your company is active in the life sciences or high-tech field, ☑️ submit your registration and join us in Niel on January 31! More information on the event can be found on the website https://lnkd.in/ef6h7pkF. #tru #cleanroomcleaning #gmpcompliancy #rulesandregulations #lifesciences #hightech

REVISED ANNEX 1 (Manufacture Of Sterile Medicinal Products) This document provides guidance for ensuring sterility in the manufacture of sterile medicinal products through a contamination control strategy (CCS). The CCS should establish robust assurance of contamination prevention from microbial, endotoxin/pyrogen and particulate sources. It involves identifying risks to product quality using quality risk management and putting in place controls like facility design, equipment qualification, environmental monitoring, personnel training and change control to minimize these risks. The CCS must describe all elements of the manufacturing process and be reviewed periodically for effectiveness in assuring sterility of the final product. Credit to #PICS #gmp #EMA #annex1 #validation

Are you facing an upcoming inspection? Developing an expert inspection management team is key.👨🔬👩🔬 Check out our blog post to learn more about the importance of subject matter experts (SMEs) in ensuring a successful inspection process. https://lnkd.in/dC7e_H6 This blog highlights the role of SMEs in answering technical questions and providing support during inspections. It also provides insights into the various disciplines that should be included in an Inspection Management Team and how to identify the right SMEs for your team. Having the right subject matter experts on your team makes a difference. Get tips to prepare for successful GxP inspections! To schedule a consultation, please visit - www.biotech.com/contact-us. #biotech #GxP #inspectionmanagement #subjectmatterexperts #sme #pscbiotech

𝐓𝐢𝐭𝐥𝐞: Lab Safety Tips from TCI   Remember, safety is our priority. Let’s protect ourselves and create a secure lab environment! #labsafety #ppe #safetyfirst #tci #safetymanagement #chemicals #pharmaceuticalmanufacturing

To ensure quality and GMP compliance, manufacturers rely on alarm notification systems. These systems provide proof of successful campaigns by ensuring there are no critical alarms related to critical quality data. That’s why an alarm notification system is an important tool for quality assurance.   https://lnkd.in/gSqc_crS