£144.07

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£144 today · usual range £128–£148 · best ever £128

Food and Drug Law Institute How to Comply with Drug CGMPs

Amazon

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Last 79 days · 79 data points

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£148.17 £125.90 £130.76 £135.62 £140.48 £145.34 £150.20 01 August 2026 20 August 2026 09 September 2026 28 September 2026 18 October 2026
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Price Distribution

Price distribution over 79 days • 5 price levels

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Current Price
24 days 11 days 3 days · current 15 days 26 days 0 7 13 20 26 £128 £140 £144 £146 £148 Days at Price

Price Analysis

Most common price: £148 (26 days, 32.9%)

Price range: £128 - £148

Price levels: 5 different prices over 79 days

Description

Globalization 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. This resource provides the legal community and regulated industry with a concise reference on the compliance standards and governing principles for current Good Manufacturing Practices. Even 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. Table of Contents Introduction I. What Are CGMPs? A. Principles B. Legal Framework C. FDA Guidance to Industry II How Does FDA Evaluate CGMP Compliance? A. Establishment Inspections B. Samples C. Field Alert Reports D. Adverse Event Reports and Consumer Complaints E. Risk-Based Selection of Sites and Inspection Frequency/Rigor F. Regulation of CGMPs for OTC Monograph and Homeopathic Drugs III What Are the Consequences of Noncompliance? A. Advisory Actions: Warning Letters, Untitled Letters and Regulatory Meetings B. Import Detentions and Import Alerts C. Recalls D. Seizures E. Injunctions F. Criminal Prosecutions G. False Claims Act and Qui Tam Investigations H. Other Consequences I. Certificates of Export/Government Contracts J. Application Disapproval/Revocation K. Application Integrity Policy IV Recent CGMP Enforcement Activity A. The Pattern of Enforcement B. GlaxoSmithKline, PLC and its Subsidiary SB Pharmco Puerto Rico Inc. C. Genzyme Corporation D. Ranbaxy Laboratories Limited and its Subsidiary Ranbaxy USA Inc. V How Do We Remain “Current” with CGMPs?

Product Specifications

Format
paperback
Domain
Amazon UK
Release Date
26 April 2017
Listed Since
27 April 2017

Barcode

No barcode data available

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