title: Quality in the pharmaceutical industry - A literature review.
abstract: OBJECTIVE
  The aim of this study is to:a.Highlight the most important guidelines and practices of quality in the pharmaceutical industry.b.Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices.
  
  
  METHODS
  A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified:a.Research theme 1: Guidelines of the pharmaceutical quality.b.Research theme 2: General practices recently applied in the pharmaceutical industry.
  
  
  METHODS
  The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP.
  
  
  RESULTS
  Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices.
  
  
  CONCLUSIONS
  It is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be done to prove the feasibility of such practices.
authors.affiliation: The National Organization for Research and Control of Biologicals, Cairo, Egypt.
authors.forename: Reham M
authors.initials: RM
authors.lastname: Haleem
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
authors.forename: Maissa Y
authors.initials: MY
authors.lastname: Salem
authors.affiliation: The National Organization for Research and Control of Biologicals, Cairo, Egypt.
authors.forename: Faten A
authors.initials: FA
authors.lastname: Fatahallah
authors.affiliation: Faculty of Pharmacy, Misr University for Science and Technology, 6th of October City, Egypt.
authors.forename: Laila E
authors.initials: LE
authors.lastname: Abdelfattah
keywords: GXPs; Pharmaceutical industry; Quality