In Pharmaceuticals - Quality Matters

The great era of total quality management (TQM) emerged in the 1980’s and bloomed during the next decade, pervading all things, products, processes and people. In pharmaceutical manufacturing it defined the industry as increasingly rigorous controls were introduced for manufacturing processes and ever stricter scrutiny exercised by regulatory authorities. Certainly this was rightly so and the industry as well as regulators have learned their lessons from the past through the grave consequences of thalidomide and subsequent scandals. Clearly, the trusting patient wants to be healed and not harmed when in the hands of healthcare professionals. The trusting practitioner wants to feel secure in prescribing drugs and not have to mistrust the major instruments of his profession.

As the era of generic drugs has evolved, quality control and assurance in manufacturing these low cost copies has become even more an issue. Generic drugs have become already a major part of the healthcare industry and will come to dominate in future years.

Nevertheless, we have seen many threats to pharmaceutical quality standards which have become somewhat taken-for-granted. Low cost countries have emerged as producers of drugs and especially generics. While there are undoubtedly high quality producers in these countries, the pressure on pricing has become severe and many producers struggle to maintain or grow their market share. This pressure has led to cost cutting and risk taking and there are many examples of companies which have fallen out of the quality fold and into the dark abyss of non-conformity. Additionally, counterfeit drugs have emerged and begun to pollute the quality environment of the pharmaceutical world. This has created confusion, mistrust and is harmful on an increasingly widespread basis as the reach of the internet has accelerated the scale of the problem.

It is therefore very challenging as a quality producer to compete in a market place distorted by these forces. Nevertheless, in drug manufacture, quality must remain king. Genuine quality also has its costs and its price tag, a lesson which must perhaps be relearned. Nevertheless, it is a standard which the industry must enforce and return to its rightful and sovereign place.

As a Contract Manufacturing Organization (CMO), Bachem is a leading producer of both research ingredients, new chemical entities and generic active pharmaceutical ingredients (APIs). The company has accumulated 40 years of know-how in its field and always maintained a quality sensitive mind-set.  In 2010, Bachem completed very successful audits by the U.S. FDA at all its API manufacturing facilities, adhering unwaveringly to the concept of continuous and current quality management and compliance in all respects.

The development of a pharmaceutical is today more than ever a risky and expensive process. Clinical trials are dependent on the use of well defined and documented products of high purity with exactly reproducible characteristics. Therefore, quality is the component which cannot be traded or relaxed and must reign supreme during the path of drug development. However, too often pricing is compared with offerings which are in fact not comparable and the CMO, being at the beginning of the supply chain, is squeezed the most. This is the case, even though for many drugs the value of the API is less than 5% of the pharmacy price. Considering that the API is the component which differentiates the drug from a placebo, placing undue pressure on API pricing can be counter to ensuring safety and quality and likely to increase risk.

Beyond the world of small organic molecules, drug development has entered a new era of ingredient categories such as peptides, oligonucleotides and recombinant therapeutic proteins. Although these ingredients are not entirely new, breakthroughs in drug delivery systems have enabled them to be applied to increasingly more therapeutic programs. As medicinal science and research has improved its understanding of disease processes, so have these new molecular classes emerged as better positioned to treat the many still unsolved health-threats to humankind.  This together with impressive breakthroughs in drug delivery has brought a new age of pharmaceutical actives which are often more selective, more potent, less toxic, and above all effective in treating diseases like cancer which have remained even  today a fearsome adversary to modern medicine.

These new, sophisticated and sensitive substances require even more appreciation of quality in their production, isolation, analysis and handling. For this reason, at Bachem we invest almost a quarter of our workforce in quality control, quality assurance and regulatory affairs. This infrastructure is costly but is an essential part of the security and reliability which Bachem sells with every gram of its products. Though not perhaps immediately evident, the quality of a pharmaceutical ingredient is reflected also in how it is produced beyond the final product purity itself.

While risk cannot be fully eradicated it can certainly be mitigated and quality is its natural counterbalance. We have in all languages a saying which embodies this thought and my own favourite is "not to spoil the ship for a halfpenny of tar". It would certainly be a shame that something so valuable and responsible for carrying lives would fail for the sake of investment in quality materials. The ill-fated Apollo 13 and later the Challenger disaster serve to remind us of the consequences of built-in defects discovered too late.  A complex clinical trial relies similarly on the importance of quality at all stages of the program to counterbalance risk. Today, the concept of "Quality by Design" (QbD) has been introduced in the industry, reinforcing the requirement that quality should be built-in by design and is "mission critical".

So for pharmaceuticals, quality matters at all stages of their life-cycle and industry participants must appreciate its benevolent rule and accept the related costs for the greater good.