PDA - Parenteral Drug Association’s Post

Excited to share insights on Good Manufacturing Practice (GMP) Ensuring quality, safety, and efficacy in pharmaceuticals, food, and medical devices, Good Manufacturing Practice (GMP) regulations are pivotal. Here's a glimpse into the meticulous process; 1.    Understanding GMP Requirements: Tailoring our approach to client needs, we delve into regulatory requirements, including inspection types and product categories. 2.    Preparing Documentation: Thorough documentation is key! From manufacturing authorization to self-inspection confirmations, every detail matters to ensure compliance. 3.    Submission of Application: With attention to detail, we formalize GMP applications, ensuring that all required documents are included with the application. 4.    Inspection by Regulatory Authorities: Anticipating inspections, we equip our clients with necessary preparations, ensuring seamless compliance with GMP guidelines. 5.    Clarification and Communication: Open communication with regulatory authorities is essential. Addressing queries promptly, we navigate the review process with transparency and efficiency. 6.    Approval and Ongoing Compliance: Success in GMP approval marks the beginning, not the end. Continuous adherence to regulatory standards is imperative for sustained compliance. At JEYFLEX CONSULTANTS LIMITED, we're dedicated to upholding the highest GMP regulatory standards, safeguarding product quality and patient safety. Let's elevate industry standards together!  #GMP #QualityAssurance #RegulatoryCompliance

Excited to share insights on Good Manufacturing Practice (GMP) Ensuring quality, safety, and efficacy in pharmaceuticals, food, and medical devices, Good Manufacturing Practice (GMP) regulations are pivotal. Here's a glimpse into the meticulous process; 1.    Understanding GMP Requirements: Tailoring our approach to client needs, we delve into regulatory requirements, including inspection types and product categories. 2.    Preparing Documentation: Thorough documentation is key! From manufacturing authorization to self-inspection confirmations, every detail matters to ensure compliance. 3.    Submission of Application: With attention to detail, we formalize GMP applications, ensuring that all required documents are included with the application. 4.    Inspection by Regulatory Authorities: Anticipating inspections, we equip our clients with necessary preparations, ensuring seamless compliance with GMP guidelines. 5.    Clarification and Communication: Open communication with regulatory authorities is essential. Addressing queries promptly, we navigate the review process with transparency and efficiency. 6.    Approval and Ongoing Compliance: Success in GMP approval marks the beginning, not the end. Continuous adherence to regulatory standards is imperative for sustained compliance. At JEYFLEX CONSULTANTS LIMITED, we're dedicated to upholding the highest GMP regulatory standards, safeguarding product quality and patient safety. Let's elevate industry standards together! #GMP #QualityAssurance #RegulatoryCompliance

The courses cover a variety of #GMP topics. 🔎Take a look and find the ones that suit you! 💡

𝗚𝗠𝗣 𝗔𝘂𝗱𝗶𝘁 𝗖𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁 𝗳𝗼𝗿 𝘀𝘂𝗽𝗽𝗹𝗶𝗲𝗿𝘀 𝗶𝗻 𝗔𝗧𝗠𝗣 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 🌐 When manufacturing an ATMP, the choice of raw materials is crucial. They impact the entire process, from IMPD to market authorization. While Good Manufacturing Practice (GMP) guidelines provide essential considerations, translating them into practice for ATMP manufacturers is key. How can one consider the origin, traceability, and composition of raw materials? How can collaboration with suppliers in the audit process be streamlined? 💡 We are delighted to present a GMP audit checklist for the qualification of suppliers and their products, in collaboration with at.las ATMP and anicells. This comprehensive document aids ATMP manufacturers in assessing suppliers - a legal obligation in EU GMP Part IV. 📥 Download your copy below and enhance your ATMP manufacturing processes. #ATMP #GMP #Manufacturing #SupplierQualification #QualityAssurance #eyetec #atlasATMP #anicells #InnovationInHealthcare #Pharmaceuticals

What exactly are #GMP guidelines, and why are they crucial for manufacturers? Dive into our blog to understand the ins and outs of GMP compliance! #manufacturing #excellence

#Regulatory #News: Revision of #AnnexI #GMP - #becomes #effective in August 2023 - #Manufacture of #Sterile #Medicinal #Products #Reasons for #changes: The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommend that the current version of annex 1, on the manufacture of sterile medicinal products, is revised to reflect changes in regulatory and manufacturing environments. The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q9 and Q10 guidelines. The revision of Annex 1 should also take into account related changes in other GMP chapters and annexes as well as in other regulatory documents. The revised guideline will seek to remove ambiguity and inconsistencies and will take account of advances in technologies. #Timeline The deadline for coming into operation of Annex 1 is 25 August 2023, except for point 8.123 which is postponed until 25 August 2024 #Reference https://lnkd.in/eaTB7bMZ #GMP #MedicinalProducts #Pharma #RiskManagement #QRM #CCS #ICH #SterileProducts

GMP REFRESH ‼️👀‼️ Quality Metrics for Drug Manufacturing Part II FDA’s Quality Metrics Program How Can Quality Metrics be used at FDA❓❓ As part of FDA’s ongoing adoption of #riskbasedregulatoryapproaches, the agency is proposing to develop and implement a #QualityMetricsReportingProgram to support its quality surveillance activities. Under this program, the #FDA intends to analyze the #qualitymetrics data submitted by establishments to: ✅obtain a more quantitative and objective measure of manufacturing quality and reliability at an establishment; ✅integrate the metrics and resulting analysis into FDA’s comprehensive quality surveillance program; ✅apply the results of the analysis to assist in identifying products at risk for quality problems (e.g., quality-related shortages and recalls). ‼️ In March 2022, FDA established a #docket to solicit comments on changes to FDA’s previously proposed Quality Metrics Reporting Program This notice describes considerations for refining the Quality Metrics Reporting Program based on lessons learned from two pilot programs with industry that were announced in the Federal Register in June 2018, a ➡️ #SiteVisitProgram https://lnkd.in/dQbXAxGt and a ➡️ #QualityMetricsFeedbackProgram, https://lnkd.in/dMUrcXP7 as well as stakeholder feedback on FDA’s 2016 revised draft guidance for industry Submission of Quality Metrics Data. https://lnkd.in/dXhmRYVU If you like this post follow me on LinkedIn

💡 The criticality of environmental monitoring (EM) relative to microbiological quality control is universally acknowledged among pharmaceutical manufacturers. And historically, manual EM has been the norm. 👉 But what if your EM program involves hundreds of samples per week? 👉 Are digital transformation initiatives soon to include EM? 👉 Or maybe you're looking to comply with EU GMP Annex 1? 💭 If you can relate to any of the above, consider 3P® ENTERPRISE from bioMérieux. This is the only offering to elegantly harmonize: ✔️ 3P® Smart 🧫 with GS1 barcodes & locking lids ✔️ Dedicated, tablet-friendly 3P® Connect software 🖥️ for digitalized EM ✔️ 3P® Station to automatize incubation and counting of 🦠 Intrigued? Learn more down below 👇 where we compare this novel approach to legacy EM methods. 📰 https://lnkd.in/dnTVq2Dx #WeArebioMérieux #pharmaQC #environmentalmonitoring #digitalization #Annex1 #QCMicrobiology

💻 Free Webinar: Annex 11 Introduction (EudraLex GMP Annex 11: Computerised Systems) 🗓️ Date: Wednesday Jun 5, 2024, 11:00 AM Cairo time 📢 This webinar covers the key EU terminology fundamental for understanding Annex 11, the history of Annex 11 and explores approaches and processes for achieving compliance. 📋 Annex 11 Webinar Topics: ▪️ Annex 11 history and background. ▪️ Scope of Annex 11 – which companies must comply. ▪️ Annex 11 requirements and approaches for compliance. ▪️ Comparison of Annex 11 vs. Part 11 (21 CFR) ▪️ Related guidance documents and standards. Register here 👇

21 CFR 211.192 — Production record review — is consistently among the top five most frequently cited components of CGMP in FDA warning letters to drug establishments. Inadequate "investigations of discrepancies" were cited 505 times between FY2018 - FY2022, based on publically available data from the FDA's data dashboard. In our webinar looking at the top-cited CFRs in both the drug and device spaces, we identified a few common problems observed in the field that indicate a problem here and common signals of a larger quality system problem and tips for preventing such issues. 𝐀 𝐟𝐞𝐰 𝐜𝐨𝐦𝐦𝐨𝐧 𝐩𝐫𝐨𝐛𝐥𝐞𝐦𝐬 𝐨𝐛𝐬𝐞𝐫𝐯𝐞𝐝 𝐢𝐧 𝐭𝐡𝐞 𝐟𝐢𝐞𝐥𝐝: ⚠ Unclear or misused discrepancy definitions prevent investigations from reaching genuine root causes "Teams often lack clear definitions for discrepancies, leading to misclassification and misguided investigations. It's crucial to adhere to standardized definitions provided by regulatory bodies like the FDA to ensure accurate categorization and effective investigations." — Neil Siegel, PhD., Industry Consultant ⚠ A lack of robust root cause analysis methods "Many investigations fail due to the absence or misuse of root cause analysis models. A thorough analysis should go beyond surface-level errors to explore underlying issues. Teams need to evaluate and refine their methodologies and ensure staff are well-trained in applying diverse, effective techniques." — Neil Siegel, PhD., Industry Consultant ⚠ “No or incomplete written record of investigation” often indicates that data aren’t recorded properly "The lack of comprehensive written records indicates improper data recording. Investigations should be as rigorous as batch records, with meticulous note-taking to ensure that comprehensive, objective evidence supports conclusions." — Neil Siegel, PhD., Industry Consultant 𝐀𝐜𝐭𝐢𝐨𝐧 𝐢𝐭𝐞𝐦𝐬 𝐟𝐨𝐫 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐚𝐬𝐬𝐮𝐫𝐚𝐧𝐜𝐞: 🔹 Review to ensure you’re using accurate definitions to steer investigations in the right direction. “Is this a genuine nonconformance, or is it an out-of-specification or out-of-tolerance issue to the measurement system?” 🔹 Be clear and concise about what you're writing down. Are notes instructive and actionable or obtuse, confusing, or misleading? 🔹 Investigate fully and methodically without jumping to conclusions. Once you’re making conclusions, are you testing them? 🔗 Watch the full webinar and grab the slide deck: https://lnkd.in/eB4U6HR #cgmp