International Journal of Pharmaceutical Compounding

A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

LEARN MORE

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations

Author(s): Allen Loyd V Jr

Issue: May/Jun 2013 - Volume 17, Number 3
View All Articles in Issue

Page(s): 210-219

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 1

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 2

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 3

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 4

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 5

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 6

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 7

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 8

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 9

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Page 10

Download in electronic PDF format for $75

Abstract: In light of recent events and discussions of compounding pharmacy, it is important to discuss and understand the purpose of good manufacturing practices. This article provides a summary of the current Good Manufacturing Practice Regulations that were established by the U.S. Food and Drug Administration.

Related Keywords: Loyd V. Allen Jr., PhD, RPh, U.S. Food and Drug Administration, FDA, good manufacturing practices, GMP, quality standards, facilities, personnel, production and process controls, component storage and labeling, product packaging and labeling, equipment, holding and distribution, laboratory controls, records and reporting, documentation

Related Categories: ENVIRONMENTAL , LEGAL, PACKAGING, QUALITY CONTROL, STORAGE

Printer-Friendly Version

Title/Author (Click for Abstract / Details / Purchase)	Issue/Page View/Buy
Related Articles from IJPC
Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Allen Loyd V Jr	May/Jun 2013 Pg. 210-219
Healthful Living: Good Practices for Good Health Jackson Kathy	May/Jun 2002 Pg. 164-166
Documentation: Records and Reports Akers Michael J	Sep/Oct 2017 Pg. 373-380
Applying Quality of Design Concepts to Pharmacy Compounding Timko Robert J	Nov/Dec 2015 Pg. 453-463
Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines Allen Loyd V Jr	Jul/Aug 2016 Pg. 351 View Sample
PreScription: GMPs vs. GCPs: Manufacturing and Compounding Definitions Allen Loyd V Jr	Sep/Oct 2013 Pg. 356
Quality-Control Analytical Methods: Selecting an Analytical Method Allen Loyd V Jr	Jan/Feb 2004 Pg. 61-64
Quality-Control Analytical Methods: High-Performance Liquid Chromatography Kupiec Thomas C	May/Jun 2004 Pg. 223-227
Quality-Control Analytical Methods: Gas Chromatography Kupiec Thomas C	Jul/Aug 2004 Pg. 305-309
The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: An Unspoken Opportunity for Pharmacists Parks Kenneth Chase, Bernard Brian, Cogdill Christopher Blake	Sep/Oct 2015 Pg. 377-380
Pharmaceutical Compounding or Pharmaceutical Manufacturing? A Regulatory Perspective Timko Robert J, Crooker Philip EM	Mar/Apr 2014 Pg. 101-111
Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh Allen Loyd V Jr	Nov/Dec 2003 Pg. 449-450
Quality Control Analytical Methods: Method Validation Klang Mark G, Williams LaVonn A	Sep/Oct 2016 Pg. 381-386
Quality-Control Analytical Methods: Glossary of Quality Control/Quality Assurance Terms in Pharmaceutical Compounding Kupiec Thomas C, Okeke Claudia, Allen Loyd V Jr, Denison Clay	Jul/Aug 2005 Pg. 300-302
Quality-Control Analytical Methods: Specific-Gravity Determinations of Liquids and Semisolids Allen Loyd V Jr	Nov/Dec 2003 Pg. 477-480
Quality-Control Analytical Methods: Osmolality and Osmometry Allen Loyd V Jr	Mar/Apr 2004 Pg. 143-145
Standard Operating Procedure: U.S. Food and Drug Administration Inspection--Releasing a Sample to the U.S. Food and Drug Administration Kupiec Tom, Kemp Jesse	Jul/Aug 2007 Pg. 326-327
PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs Allen Loyd V Jr	Sep/Oct 2017 Pg. 356
NABP Guidelines: Good Compounding Practices Applicable to State-Licensed Pharmacies Allen Loyd V Jr	Mar/Apr 1997 Pg. 75-77
Standing Together Fixing the Drug Quality and Security Act Miller David G	Mar/Apr 2015 Pg. 104-106
Return to Top