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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?
