Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of all issues and individual articles published by the Journal since 1997.

PreScription: GMPs vs. GCPs: Manufacturing and Compounding Definitions

Author(s):  Allen Loyd V Jr

Issue:  Sep/Oct 2013 - Volume 17, Number 5
View All Articles in Issue

Page(s):  356

PreScription: GMPs vs. GCPs: Manufacturing and Compounding Definitions Page 1

Download in electronic PDF format for $75

Abstract:  

Related Keywords: regulation, U.S. Food and Drug Administration, FDA, regulatory agency, compounded sterile preparations, quality control, drug safety, good manufacturing practices, good compounding practices, GMP, GCP, United States Pharmacopeia, USP

Related Categories: LEGAL, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
PreScription: GMPs vs. GCPs: Manufacturing and Compounding Definitions
Allen Loyd V Jr
Sep/Oct 2013
Pg. 356

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations
Allen Loyd V Jr
May/Jun 2013
Pg. 210-219

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
Pharmaceutical Compounding or Pharmaceutical Manufacturing? A Regulatory Perspective
Timko Robert J
, Crooker Philip EM
Mar/Apr 2014
Pg. 101-111

PostScription: GMPs and GCPs: A Topical Comparison
Allen Loyd V Jr
Jan/Feb 2013
Pg. 87

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

Documentation: Records and Reports
Akers Michael J
Sep/Oct 2017
Pg. 373-380

PostScription: GMPs vs. GCPs: United States Pharmacopeia General Chapters
Allen Loyd V Jr
Sep/Oct 2013
Pg. 439

U.S. Food and Drug Administration Proposed Guidance Document: Compounding Animal Drugs from Bulk Substances
Miller David G
Jul/Aug 2015
Pg. 303-305

U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies
Yoch Doug
Mar/Apr 2017
Pg. 95-102

U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs
Allen Loyd V Jr
Nov/Dec 2015
Pg. 487-488

Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1
Martin Matt
Sep/Oct 2018
Pg. 401-404

NABP Guidelines: Good Compounding Practices Applicable to State-Licensed Pharmacies
Allen Loyd V Jr
Mar/Apr 1997
Pg. 75-77

Applying Quality of Design Concepts to Pharmacy Compounding
Timko Robert J
Nov/Dec 2015
Pg. 453-463

The U.S. Food and Drug Administration Takes Aim at Compounded Thyroid Hormone
Brunner Scott
Jan/Feb 2023
Pg. 22-23

Compounding in the Pharmacy Curriculum: Beyond the Basics
Hinkle Amanda R
, Newton Gail D
May/Jun 2004
Pg. 181-185

Safety Standards in Pharmaceutical Compounding, Part 2: A Closer Look at Agency Information, Oversight, and Assistance
Greeson Nicole MH
, Mixon William, Allan W Chris
Sep/Oct 2020
Pg. 371-379

PreScription: Compounded Drugs Often Become Manufactured Drugs
Allen Loyd V Jr
Nov/Dec 2022
Pg. 444

PreScription: Compounding for Drug Shortages
Allen Loyd V Jr
May/Jun 2013
Pg. 180

Quality Control and Basics of Sterile Compounding: Attempting to Avoid Out-of-Specification Results and Patient Harm in Sterile Compounding
Martin Matt
Jan/Feb 2019
Pg. 47-49

Return to Top