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.
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