There is a growing awareness that an improvement in the quality of pharmaceutical products and services is a vital factor in the battle to maintain sales and remain commercially viable in the fast-growing and changing market. In many markets, quality competition is at least as important as price competition and this trend is bound to continue. With the prospects of more stringent product liability legislation and the threat of heavy financial penalties for products and services which fail to meet safety, good manufacturing compliance (GMP) or functional requirements, profitable trading will depend on sound Quality Assurance best practices. Material resources are becoming scarce and most expensive, and it is therefore economically desirable to minimize losses on scrap products by more effective quality control.
Quality has been defined as the totality of features and characteristics of a product or service that bears on its ability to satisfy a given need; and Quality Assurance as all activities and functions concerned with the attainment of quality. The concepts include sound marketing analysis to establish customers’ requirements and satisfactions; ensuring that designs reflect these requirements in fitness for purpose at an economic cost, reliability considerations and the practical constraints imposed by manufacturing capability; organizing and controlling production to consistently conform to design specifications; and following up these actions with adequate after sales services and the feedback of relevant field data.
This importance of reliable product quality cannot be overemphasised when one is attempting to break into new markets and win new business. It is now an established fact that many pharmaceutical potential markets are far more demanding in this respect than were customers in the past. In addition, more legislation and regulations relating to product conformance and reliability are coming into operation. It is recognized that the most effective advertisement for a product or service is the satisfied customer. Making a conquest sale has been estimated to cost a company ten times the repeat sale. The performance of the product is totally dependent on good design and development coupled with conformance during manufacture to the specification and build process.
The quality of a product does not occur by accident. People throughout an organization do not always carry out instructions, or perform their role correctly. It is the continuing task of quality management to deal with this situation and ensure that all members of the industrial team are aware of their quality responsibilities and are accountable for their actions. Quality must be designed into products – discipline, attitude and inventiveness must be encouraged to create easy to make and easy to use fool proof products. Quality must then be planned into manufacture – methods must be devised so that the easiest way to do the job is the right one; so that, where appropriate, worker interest is created; and elsewhere complete control is built into the process. Finally, quality must be built into the product – the people concerned with the cutting, fitting and assembling must be well trained and enthusiastically led to achieve “right first time” production. This is the simple overall formula, but it is by no means simple to put into practice.
To make quality assurance an effective part of business, Senior Management must be clearly committed to developing and implementing an effective Quality Policy. The implementation of such a policy involves everyone in the company. It must be clearly recognized that every employee (from board to shop floor) is responsible for ensuring that GMP and good quality practices are achieved. All departments within a company must be held accountable within their own spheres of influence for ensuring that for the selling price of the product, the required quality standards are inherent within the design and methods, processes specified and the materials and equipment provided.
The Quality Executive
The role of Quality Executive in industry is nowadays highly specialized. The post is not one that can normally be used as a “stepping stone” in a promotional ladder. The reason is fairly obvious; a person in a Quality Executive role can gain popularity and short term achievement by effecting cost reductions and in making favorable decisions, etc., only for the company to have to pay later. There are good reasons as to why there are dangers in making short term assessments on achievements in this sphere. It is a job that is essentially involved in long term consequences and as a consequence it is not always a particularly popular job.
The idea that the work of quality organizations was simply that of “inspecting out” defective work which had already been produced was widespread in the past, particularly in management circles. As a corollary, it also followed that the kind of person required was low level and fairly non-technical. In this belief, management has not kept abreast of the developments which began during the 1939/1945 world war and which have been accelerating in the last decade.
It is true to say, particularly over the last decade, that there has been considerable technical advance in the nature of the work of quality specialists. These have taken them a long way away from the old idea of inspection pure and simple. Today’s emphasis in the work of quality specialist is towards the prevention of defect altogether. The modern view is that “no inspection is good inspection”. In order to achieve this goal, a high degree of professionalism is required in these new techniques, which call for considerable study and practical experiences leading to qualification as quality practitioners.
In addition to these recognizable technical factors, an urgent need has arisen for quality professionals to broaden their experience into a field which, until now, would have been considered to be completely foreign. This need has developed due to the imminence of international and national legislation relating to product liability. This has taken the quality professional into the fields of insurance and the law. It has also meant, although most of these other disciplines do not yet appear to realize the fact, a great widening of the circle of operations in a company to which the quality professional must direct his attention for assurance purposes. The scope of this new, wider area and the urgency which must be attached to it are such that it is clear that the Quality Assurance function will have to be applied throughout a company organization.
Quality cannot however be achieved solely by the Quality Executive, it depends on everyone being actively involved. The Quality Executive’s contribution is essentially one of coordinating the efforts of others to ensure the achievement of quality by communicating information on the many aspects affecting quality to all concerned and exercising control over quality monitoring throughout the organization. It must be the task/goal of all managers to ensure that the quality function of their own departments is fulfilled. This places a heavy responsibility on all senior managers.
The Responsibility of Senior Management
To achieve the desired quality standard means that management organization and management thinking has to be well structured so as to ensure that quality and reliability figure appropriately in corporate planning. It is essential for any manager not only to have a good appreciation of the fundamentals of quality and reliability, but also fully understand his/ her own responsibility for the management and achievement of quality and reliability. Only by having this knowledge can he/she determine the correct levels of resources which must be deployed.
- To determine the quality and reliability requirements of customers or the intended market place;
- To control the design and manufacture of goods to meet these requirements;
- To provide the customers with adequate confidence those goods when received and put into operation will conform to their specifications/requirements.
In some industries, it may well be that these are infrequent judgements taken for a long-running production line. In other industries, each project may have different requirements. The resources one needs to deploy can vary greatly and be dependent on the importance of its function. All managers need to be able to talk and act in a knowledgeable way about the issues which affect product quality, and also understand the factors which determine the state of product quality. This means that they should regard quality as an equal factor with price and delivery in running their business. One of the basic problems is that most companies are managed from a purely financial point of view and, to the extent that they must be managed with the objective of making a profit, this is entirely correct. However, because of this attitude there is a danger of managing with the primary objective of making a product at the lowest possible price, in the belief that it is the price which determines whether a product sells in the market place. There is truth in that statement, but it is equally true that a product will not sell if it is not the right one for the market. It is also a fact that repeat sales will not be achieved if customers have not been satisfied with the quality and reliability of products they have purchased. Often because of the emphasis given to price and timescale, and the lack of concern with quality assurance, there are attempts to “add quality” as an extra – always expensive and frequently ineffective. The importance of product design and product quality on the competitiveness of goods in the marketplace cannot be stressed enough.
Managers should be aware that the quality of their products is a vital factor in the continuing competitiveness and profitability of their company. Not only should they be concerned with producing products at the right price and at the right time, but they should also ensure that they are marketing the right product and that it will fully meet the customer’s and regulatory compliance requirements. Marketing, Design, Production and Services Managers should all be aware of their responsibilities for GMP/quality best practices as a vital part of their commitment to ensure the continuing efficiency, profitability and reputation of their company. Lip service is not enough; in today’s economic environment there are positive commercial benefits in adapting a vigorous quality policy, but this can only happen when knowledgeable and fully trained managers have adequately planned and implemented that policy. Managers become knowledgeable and competent through experience, but they must be trained at some stage, or stages, in the fundamentally important issues. Quality in today’s world is one of these fundamental issues. The initial seeds of the importance of quality assurance to higher management should be sown when a manager is receiving his management education, and subsequently updating courses should be provided to match the requirements of rapidly changing technology and regulatory compliance requirements. Finally, senior management has the ultimate responsibility to ensure an effective quality assurance system is in place to achieve the product quality and reliability [1].
The Quality Assurance Content of Management Training
It is now more essential than ever before for senior management executives in pharmaceutical organizations to have an understanding of their involvement in the expanding quality assurance functions by the international regulatory agencies. Management training programs need not, and should not, be designed to train specialized quality executives. They should, however, include adequate content to provide an awareness of what is involved in assuring the quality of products and services. The following subjects should be included:
- The philosophy of quality assurance and the reasons why it is as necessary for future prosperity and survival as a competitive industry.
- The concept that high quality products or services have to be planned from concept right through all stages to after-scales back-up.
- The techniques of quality assurance and the necessity to measure the level of effectiveness of the output from the function under review.
- The emphasis on effective quality control being cost recoverable and an essential part of the profitability picture.
- The problem associated with motivation for quality in all functions of the organization.
- The identification of total cost of achieving and maintaining quality.
Table 1. Some Facts About Quality Assurance
Total quality costs and their division between the above mentioned categories vary considerably from industry to industry, and from plant to plant.
- Quality Cost Analysis can help Management:
- Measure effectiveness of overall quality activities of the business;
- Analyze business performance in terms of identifying major loss areas;
- Budget effectively for realistic investment in failure prevention programs;
- Plan overall quality assurance activities to achieve optimum results in all departments;
- Minimize preventable losses, and thus tap a large reserve of capital resources.
Quality Assurance
Quality assurance is a broad concept covering all matters which individually or collectively influence the quality of a product. It is the total sum of the organized arrangements made with the goal of ensuring that medicinal products are of the quality required for their intended use. It is good manufacturing practice, plus factors outside the scope of this guide [2] such as original product design and development.
Objectives of Quality Assurance
- To protect the user of the product from accidental defect in its design, manufacture, storage, or usage instructions.
- To ensure that the person administering the medicine has confidence that each unit will achieve its desired effect.
- To protect the manufacturing organization.
- To ensure compliance with the law.
Competition in the Market Place
Price Competition: At a time when material resources are becoming scarcer and more expensive and labor costs continue to increase, all waste represents a burden on the industrial economy and leads to higher product costs. By reducing the quantity of defective products and the failure rate of manufactured items, precious resources are conserved and production costs minimized.
Quality Competition: In an increasing number of markets, quality competition is at least as important as price competition. The success of Japanese and German industry, both operating with a strong currency exchange rate, is apparent to all. Products with a reputation for quality and reliability sell in large quantities throughout the world, often overcoming the domestic competition in spite of their higher prices. This success, which is shared by all too few industries around the world, has been achieved very largely by the priority given to quality assurance.
Product and Safety Liability
Pharmaceutical manufacturing industries are now becoming aware of the full implications of strict product liability; although for some time those businesses exporting to the USA have been liable to heavy penalties for inadequate or defective products.
The introduction of new product liability legislation throughout the developed world is now imminent. This will have a profound impact on industry, and all businesses wishing to continue profitable trading should give thought to the application of safety- orientated procedures which will minimize product liability risks.
Quality assurance, already widely recognized as an important management tool, has now been generally accepted in the US as the primary means of implementing effective product liability prevention programs. Now is the time for the pharmaceutical industry to follow suit, for firms that ignore the dangers will certainly be in considerable financial peril.
References
- International Conferences on Harmonization (ICH), Food and Drug Administration (FDA), Guidance for Industry, Q10: Pharmaceutical Quality Systems, April, 2009.
- Medicines and Healthcare Products Regulatory Agency (MHRA), Rules and Guidance for Pharmaceutical manufacturers and Distributors, Pharmaceutical Press, London, 2007, p. 43.
Dr. Ghulam Shabir (BSc, MSc, PhD, CSci, CChem, FRSC, FCQI, CQP, Lean Six Sigma Green Belt Certification, ISO Lead Auditor and Train the Trainer Certification) is Founder and Managing Director of DGS PharmaTraining Ltd. He is also a visiting Research Fellow of Oxford Brookes University, Oxford, UK. Dr. Shabir has more than 27 years of leadership and management experience in WHO, EU/MHRA and US FDA GMP compliance pharmaceutical and medical devices industries. He received his Ph.D. in Analytical Chemistry from the University of Sunderland, UK. He is a Fellow and Chartered Chemist of the Royal Society of Chemistry, Chartered Scientist of the Science Council UK, Fellow and Chartered Quality Professional of the Chartered Quality Institute, London and Member of the American Society for Quality. Dr. Shabir is the author of over 65 peer-reviewed papers and the author of 3 books. He is also a member of editorial boards for various journals including American Pharmaceutical Review. He has received World's top cited articles author awards from Elsevier and Taylor & Francis.