Highlight the most important guidelines and practices of quality in the pharmaceutical industry. Organize such guidelines and practices to create a guide to quality control of pharmaceutical products pdf the way for other researchers who would like to dig deeper into these guidelines and practices.
56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. Research theme 1: Guidelines of the pharmaceutical quality. Research theme 2: General practices recently applied in the pharmaceutical industry. The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP. 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.
Peer review under responsibility of King Saud University. Production and hosting by Elsevier B. Findings from a study on import testing, based on data collected from six multinational pharmaceutical companies, suggest that import testing does not add significant benefits to the quality or safety of drugs, provided that the products are uninterruptedly controlled according to the globally harmonized manufacturing and distribution standards. Garbe Karl Ennis Guido M. Enter the terms you wish to search for.
Display a printer-friendly version of this page. Send this page by email. Findings from a study on import testing suggest that import testing does not add significant benefits to the quality or safety of drugs, provided that the products are uninterruptedly controlled according to global standards. In fact, it was observed that import testing could potentially increase risks to the patient by causing delay in the supply chain and other complexities. Today, pharmaceutical, vaccine, and the biotechnology industries have developed and implemented robust quality systems and control of the supply chain to ensure the identity, safety, purity, and potency of its drug products throughout their manufacture and international distribution channels.
This perspective has been evidenced by data presented herein, analyzing quantitative figures on import testing collected from multinational pharmaceutical companies. Johnson, and Pfizer—associated with IFPMA, unless otherwise specified. In total, 184 data sets of information on 149 countries, collected from September to November 2014, were analyzed. Categories of re-testing in the country of destination.
Apart from re-testing associated with the import of pharmaceutical products, other testing categories were reported. Causes prolonged storage of the goods in warehouse upon import. Can lead to delayed supply of medicine to the patient or product stock-out. Can result in a significant delay to availability of new innovative medicines to patients. Does not usually impact supply during the commercial phase.
Represents an independent control of medicines on the market. These data may also help to understand these threats and to define appropriate measures. No delay in access of medicines to patients. An accepted practice to monitor the quality of marketed medicines.
Status as of November 2014. Multiplication of tests along the global supply chain. Multinational manufacturers manage global product supply chains. Accordingly, the same batch may undergo several re-tests.
The local re-testing process takes significant time. Information from 29 operations in 18 different countries was received. OOS investigations, and batch rejections. Six companies reported a total of 18,616 re-tests performed per year. Of these, one re-test resulted in a batch rejection. Companies provided details of additional resources required for local re-testing even if the testing is not performed under their responsibility.