The document discusses quality management systems (QMS) and good manufacturing practices (GMP) and their benefits for businesses. It provides an overview of the key elements of a QMS and explains that a QMS establishes procedures and processes to ensure quality control across all aspects of a business. It then describes GMP guidelines which outline manufacturing and testing standards for pharmaceuticals and medical devices to ensure product quality and compliance. The document notes that many countries have legislation requiring companies to follow GMP procedures.

1. Quality Management System (QMS) and GMP Benefits to Your Business

2. Quality Assurance in the Modern Business Environment The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances. Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.

5. Enforcement GMPs are enforced in the United States by the US FDA under Section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). 21 CFR Parts 210 and 211 - Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; General and Current Good Manufacturing Practice For Finished Pharmaceuticals are mandatory as well. The 1962 Kefauver-Harris Amendment to the FD&C act represented a "revolution" in FDA regulatory authority. The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form. The amendment was a response to the Thalidomide tragedy, in which thousands of European babies were born deformed after their mothers took that drug - marketed for treatment of nausea - during their pregnancies. Thalidomide had not been approved for use in the U.S. due to the concerns of an FDA reviewer, Frances Kesley. However, thousands of "trial samples" had been sent to American doctors during the "clinical investigation" phase of the drug's development, which at the time was entirely unregulated by the FDA. The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA's version in the US. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP.

6. Competitive Advantage by Reducing Regulatory Risks In pharmaceuticals and medical products quality control has historically taken a backseat to innovative science and compelling marketing, the standard drivers of the industry’s profitability. Recently, though, industry executives have had no choice but to sit up and take notice, as poor quality and related compliance issues have cost the industry more than $700 million in fines since 2001 and billions more in lost revenues. While some pharma companies are improving their manufacturing quality substantially, many more have been slow to study and achieve world-class practices. Rather than building quality into and across manufacturing processes themselves, many companies have used the risky and costly method of trying to ensure quality by removing defective products during inspections. This approach is not sustainable, especially as the Food and Drug Administration (FDA) and other regulatory agencies have shifted their focus to monitor not only a company’s outputs but also its processes and systems. The fact is, various pharmaceutical companies regularly fail FDA inspections, and worse, are forced to comply – via legal action and the courts – just to follow manufacturing guidelines. In fact, the government, via the FDA, has had to levy ever greater fines on the pharmaceutical industry in recent years, to force them to simply follow existing QC regulations and guidelines.

9. Implications In the face of a challenging regulatory environment, some leading pharmaceutical and medical-product companies have found ways to improve quality and costs significantly. To drive this kind of beneficial change, companies must first create a culture where quality objectives are transparent, well understood, and undoubtedly important. Then managers must focus resources on the product and process attributes truly critical to delivering quality products. Adding quality measures to manufacturing processes midstream, simplifying quality and compliance-management systems, and working to monitor and measure quality performance effectively will combine to raise quality and lower the risk of compliance issues. Companies that succeed in implementing these changes can create a competitive advantage through superior performance on cost and quality: they dramatically reduce variability, the risk of noncompliance, and time to market while freeing up funds for investment.