There are a variety of views on the most important function within an organisation. In recent years, industries whose organisations have been marketing-led or customer-driven have been cited as the ideal. Within other industries, including the pharmaceutical industry, there is an alternative view that proposes that a company should be research-driven.

It is probable that the most successful organisations are those that manage to remove the functional silos and integrate all the activities of the company on an equal footing.

Declining importance of manufacturing

One thing that is clear is that the days of the manufacturing-driven organisation are over. Even in the former socialist economies, where manufacturing quotas were all that was considered, there is a growing recognition that productivity in isolation from sales is meaningless.

However, in an industry as highly regulated and quality-critical as the pharmaceutical industry, the ability of the manufacturing function to deliver consistent quality is a prerequisite for remaining in business.

Pharmaceutical manufacturing is in a state of flux. From a global perspective, there is excess capacity in traditional secondary anufacturing facilities. The situation is not so clear-cut for active pharmaceutical ingredients (APIs) and is certainly not true for biotechnology manufacturing, where there is currently a shortfall. For the past decade multinational companies have been undergoing a process of rationalisation. This trend is set to continue as mergers and acquisitions create larger companies with duplicate resources and facilities around the world. Hence there is a part of the industry that is shrinking.

There are local companies, particularly those in the emerging markets, that are trying to expand into exports and are recognising that to do this requires an ability to satisfy the ever-increasing quality standards of both the home and export markets.

In all companies, there are major decisions being taken on subjects such as where to manufacture, what to make and how much to invest. In most, if not all companies, the majority of Board members approving these decisions have backgrounds in the commercial or financial rather than technical disciplines. However, it is essential that they all have a broad understanding of the issues, to ensure that decisions are taken on an informed basis.

Pharmaceutical manufacturing is an expensive process. It is important that investment in manufacturing is recognised as just that – an investment – rather than an expense that brings no returns. The question ‘Why should we invest this money?’ should be balanced by an understanding of the implications of not making that investment.

Core competencies

For many companies manufacturing is not seen as a core competency. It is considered merely as one of the activities that must be carried out efficiently and effectively for the company to perform. However, the effect on the stock value and image of the company of not getting it right has been amply demonstrated in recent years by some companies. The level of fines being levied by the Food and Drug administration in consent decrees makes it financially very painful for companies that fail to comply to standards.

The objective of this report is to provide an overview of pharmaceutical manufacturing for the benefit of non-technical decision-makers, so that their decisions on the future of manufacturing within their organisations are made from a more fully informed basis. It may also serve as a reference text for companies in the emerging markets that are starting out on the journey towards international standards of quality in manufacturing.

This report deals mainly with secondary manufacturing of finished pharmaceuticals but reference is made to primary manufacturing of APIs, and biotechnology companies.

The report reviews the situation around the world with regard to pharmaceutical companies and discusses some of the historical developments in reaching that point, including an overview of key issues facing the industry. It examines the relationship between manufacturing and sales and presents an overview of the current manufacturing base from a geographical perspective.

Key issues facing manufacturing facilities are examined and the options available to companies in developing a strategy for manufacturing are discussed. There is also a discussion on the topic of quality management. This is followed by an overview of the quality requirements with respect to manufacturing, presented geographically and dealing with the major regulatory bodies worldwide.

The report also tackles the more practical aspects of manufacturing.

There is a review of the main dosage forms being produced and the related technologies, both current and developing. There is a discussion of the relative merits of green-field sites versus refurbishment. The growing topic of validation is dealt with in great detail, as this is an area of significant expenditure often misunderstood by senior management. The section concludes with a presentation of both the costs and benefits of validation.

The report closes with a discussion of the likely trends over the next decade and attempts to predict the shape of pharmaceutical manufacturing in 10 years time.