1. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). 1. 贵公司的...
FDA Predetermined Change Control Plan (PCCP) Template White Paper - Ketryx Compliance Frameworkwww.ketryx.com/white-papers/pccp-template FDA关于PCCP的官方网络研讨会 Webinar - Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled...
change control变更控制 CGMP-related trainingCGMP相关培训 issuing batch records批记录发放 documenting batch record review记录批记录审核 cleaning清洁 storage conditions存贮条件 Your firm’s quality systemsare inadequate. See FDA’s guidance document,Quality Systems Approach ...
1. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm failed to provide adequate oversight and ensure the...
In the guidance, the FDA outlines how manufacturers can submit a predetermined change control plan (PCCP) to obtain preapproval for iterative, or minor, changes to devices after they're on the market. A PCCP could prove a welcome solution for the government and developers by reducing th...
19.4 Control of Raw Materials 原料的控制 19.5 Production 生产 19.6 Validation 验证 19.7 Changes 变更 19.8 Laboratory Controls 实验室控制 19.9 Documentation 文件 20. Glossary 术语 1. INTRODUCTION 1. 简介 1.1 Objective 1.1目的 This document is intended to provide guidance regarding good manufacturing pra...
FDA recently released its finalguidancefor Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). The final guidance hasn’t changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP ...
Draft Guidance Topics • Chemical Analysis for Biocompatibility Assessment of Medical Devices 医疗器械生物相容性评价之化学分析 • Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 关于人工智能/机器学习(AI/...
Any modification to an authorized PCCP requires resubmission of the full marketing submissionalong with the modified PCCP. The draft guidance states that if a “device has been relatively unchanged since FDA’s prior authorization and a new PCCP is proposed, FDA would focus its re...
Final Guidance Topics Remanufacturing of Medical Devices Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act Marketing Submission Recommendations for A Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Soft...