Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Guidelines page guides you to important GMP and Regulatory guidance’s; Provides links to published final and draft guidelines of regulatory authorities like USFDA, EMA, WHO, MHRA, TGA and other NRAs. The page provides links to guidance’s and scientific discussion papers by expert bodies and technology platforms like ISPE, PICS, APIC, USP.
Guidance’s, literature and scientific discussion papers are collated subject wise to help navigate quickly to relevant document. Scroll over the titles to know which guidelines and topics are listed under the title. Click on + to open the list.
Qvents compilation of regulatory guidance’s on Computer System Validation, Electronic Data Review from USFDA, EMA, PIC-S.
Access all guidelines on the topic – from USFDA 21 CFR Part 11 requirements, Questions and Answers, Document heavy CSV approach, Risk based frame work of CSA. Revised EC Annex 11 with focus on cybersecurity controls and EC Annex 22 focus on AI systems
Qvents compilation of regulatory guidelines on Data Integrity : FDA guidance for design, operation, and monitoring of systems and controls based on risk to patient, process, and product, Role of management, ALCOA++, meta data and audit trail, MHRA focus on organisational culture and data criticality based systems, WHO explanation of data governance and arrangements to provide assurance of data quality, Hybrid systems, Data Management and Pharma Quality Systems, PIC-S guidance, EMA and FDA requirements comparison, Data Integrity checklists
Qvents compiled list of regulatory guidelines on GMP inspections from different agencies – USFDA, EMA, EDQM, WHO, PIC-S. Quick reference list:
What are different types of Inspections, GMP Inspection Process, Fees, Links to Inspection guides and checklists, Inspection outcomes, Regulatory actions, Consequences of denying, delaying, refusing GMP inspections, Post inspection remediations, Post Warning letter meetings, Useful presentations on GMP Inspections
Hold time studies: