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.

3. Quality Management System Elements of a Quality Management System: Organizational Structure Responsibilities Methods Data Management Processes Resources Customer Satisfaction Continuous Improvement A well managed quality system will have impact on: customer loyalty and repeat business market share operational efficiencies flexibility and ability to respond to market opportunities effective and efficient use of resources cost reductions competitive advantages participation and motivation of human resources industry reputation control on all processes A quality management system (QMS) can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.

4. Good Manufacturing Practice " Good manufacturing practice " or " GMP " is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Although there are a number of them, all guidelines follow a few basic principles. Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary. Instructions and procedures are written in clear and unambiguous language. Operators are trained to carry out and document procedures. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. The distribution of the drugs minimizes any risk to their quality. A system is available for recalling any batch of drug from sale or supply. Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

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.

7. Noncompliance Results The FDA fined Schering-Plough Corp. $500-million for repeatedly failing plant inspections after the FDA set strict quality control terms on four Schering-Plough facilities. FDA inspectors found "significant violations regulations related to facilities, manufacturing, quality assurance, equipment, laboratories and labeling." If that were not bad enough, the company shipped out asthma inhalers that contained little or no active ingredient (albuterol) leading to perhaps as many as 17 deaths according to the Public Citizen's Health Research Group. Several massive recalls were the result. Once held up as the model of success in bio-tech, Genzyme Corp , "Under the consent decree of permanent injunction," agreed to correct manufacturing quality violations at one of its facilities and will return $175 million in "unlawful profits" from the sale of products that were made at the plant. According to the FDA, in addition to failing various QC issues, some products were "contaminated with metal, fiber, rubber and glass particles." Abbott Laboratories ' recall of Similac infant formula after insect parts were found in some batches. Intravenous drugs from Amgen and Novartis recalled for the presence of glass flakes supposedly caused by a breakdown of materials in the stored vials. Johnson & Johnson (J&J) having to recall nearly 200 million bottles of various over-the-counter drugs due to "foul odor." According to a Reuters Report (Tue May 4th, 2010) FDA "...inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products..." with "... raw ingredients contaminated by an unspecified bacteria, a lack of quality control procedures and poor handling of complaints, according to the report dated April 30." It was so bad, The FDA "...urged consumers to stop using liquid Tylenol, Motrin, Benadryl and Zyrtec for children and infants after a broad recall..." recommending people use generics instead. The company has suspended production at the plant GlaxoSmithKline recently paid $750 million in civil and criminal penalties for "knowingly selling contaminated, adulterated and ineffective drugs"* produced from it's now closed plant in Puerto Rico. Some of the drugs produced at this plant, and known to be affected were: Paxil, Bactroban, Coreg, Tagamet, and Avandia. As of this writing, the investigation is ongoing and additional civil and criminal charges may still be handed down.

8. Current Situation in Russia Russia is going to become a PIC/S member. GOST R 52249-2009 is a Russian equivalent of the GMP standards. The GOST has remarkable weaknesses: Quality risk management is not mentioned; GOST is not mandatory document in Russia, so: There is no sanctions for the GOST violation; System of control over the GOST requirements implementation is not introduced. Introduction of GMP Standards by 2014 : A key feature of the recently approved law “On the Circulation of Drugs,” is that all pharmaceutical companies operating in Russia who have not already implemented European Good Manufacturing Practice (GMP) standards in their operating facilities will be required to do so before 1 January 2014. Any companies who have not already implemented GMP standards by this date will have their licence revoked. According to Russia's health minister Tatyana Golikova, only 30 of the 400 pharmaceutical companies operating in Russia are GMP compliant.

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.