{"product_id":"9781935065838","title":"How to Comply with Drug CGMPs","description":"\u003cp\u003eGlobalization in the pharmaceutical industry, expanded FDA authority over CGMPs, and increased scrutiny of data integrity, among other developments in this rapidly evolving field, make for a complex compliance environment.\u003c\/p\u003e\u003cp\u003eThis resource provides the legal community and regulated industry with a concise reference on the compliance standards and governing principles for current Good Manufacturing Practices.\u003c\/p\u003e\u003cp\u003eEven as these standards will change over time, the underlying concepts discussed will help the reader understand these changes, and how to incorporate them into a robust compliance program.\u003c\/p\u003e\u003cp\u003e\u003cu\u003eTable of Contents\u003c\/u\u003e\u003c\/p\u003e\u003cp\u003eIntroduction \u003c\/p\u003e\u003cp\u003eI. What Are CGMPs? \u003c\/p\u003e\u003cp\u003eA. Principles\u003c\/p\u003e\u003cp\u003eB. Legal Framework\u003c\/p\u003e\u003cp\u003eC. FDA Guidance to Industry\u003c\/p\u003e\u003cp\u003eII How Does FDA Evaluate CGMP Compliance?\u003c\/p\u003e\u003cp\u003eA. Establishment Inspections\u003c\/p\u003e\u003cp\u003eB. Samples\u003c\/p\u003e\u003cp\u003eC. Field Alert Reports\u003c\/p\u003e\u003cp\u003eD. Adverse Event Reports and Consumer Complaints\u003c\/p\u003e\u003cp\u003eE. Risk-Based Selection of Sites and Inspection Frequency\/Rigor\u003c\/p\u003e\u003cp\u003eF. Regulation of CGMPs for OTC Monograph and Homeopathic Drugs\u003c\/p\u003e\u003cp\u003eIII What Are the Consequences of Noncompliance? \u003c\/p\u003e\u003cp\u003eA. Advisory Actions: Warning Letters, Untitled Letters and Regulatory Meetings\u003c\/p\u003e\u003cp\u003eB. Import Detentions and Import Alerts\u003c\/p\u003e\u003cp\u003eC. Recalls\u003c\/p\u003e\u003cp\u003eD. Seizures\u003c\/p\u003e\u003cp\u003eE. Injunctions\u003c\/p\u003e\u003cp\u003eF. Criminal Prosecutions\u003c\/p\u003e\u003cp\u003eG. False Claims Act and Qui Tam Investigations\u003c\/p\u003e\u003cp\u003eH. Other Consequences\u003c\/p\u003e\u003cp\u003eI. Certificates of Export\/Government Contracts\u003c\/p\u003e\u003cp\u003eJ. Application Disapproval\/Revocation\u003c\/p\u003e\u003cp\u003eK. Application Integrity Policy\u003c\/p\u003e\u003cp\u003eIV Recent CGMP Enforcement Activity \u003c\/p\u003e\u003cp\u003eA. The Pattern of Enforcement\u003c\/p\u003e\u003cp\u003eB. GlaxoSmithKline, PLC and its Subsidiary SB Pharmco Puerto Rico Inc.\u003c\/p\u003e\u003cp\u003eC. Genzyme Corporation\u003c\/p\u003e\u003cp\u003eD. Ranbaxy Laboratories Limited and its Subsidiary Ranbaxy USA Inc.\u003c\/p\u003e\u003cp\u003eV How Do We Remain “Current” with CGMPs?\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e","brand":"Food and Drug Law Institute","offers":[{"title":"Default Title","offer_id":47019675615472,"sku":"9781935065838","price":199.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0737\/7593\/9824\/files\/9781935065838_p0.jpg?v=1763655761","url":"https:\/\/shop-qa.barnesandnoble.com\/products\/9781935065838","provider":"Barnes \u0026 Noble (DEV)","version":"1.0","type":"link"}