Pharmaceutical companies attributes

Many pharmaceutical and healthcare companies attribute higher costs to validation. One reason why higher costs may be quoted is that these include the cost of implementing basic quality assurance practices that should already be in place. A review of major computer validation non-compliance identified by regulators demonstrates that fundamental management controls are often missing or failing. The above metrics are predicated on the assumption that basic quality assurance practices are already in place. 

The integration of the computer system (hardware, software, and instrumentation) must be confirmed in readiness for the subsequent OQ activity. Some practitioners have referred to this as the testing of static attributes of the computer system. The importance of completing the IQ before commencing the OQ can be illustrated by a recent incident in which a pharmaceutical company had over 35% of the instrumentation for a multiproduct plant but did not have available calibration certificates. There were various reasons for this, but none were recorded. Some instruments were no longer used, some had extended recalibration periods, and some had been undergoing calibration for several weeks. The net effect was that the computer system under quahfication was clearly not in a controlled state suitable for the OQ, and in consequence, it was not ready for use. 

Quantitation of drags and their metabolites in biological matrices currently is one of the most important applications of LC-MS. This can be attributed to the greatly enhanced selectivity and reliability of the analysis, as compared to LC-UV. Selective reaction monitoring (SRM) in tandem mass spectrometry (MS-MS) has become the method-of-choice in quantitative bioanalysis. Ample examples are described in literatnre. Even a larger number of successful examples are hidden in the archives of pharmaceutical companies and contract research organizations. 

There is a growing need for companies to be able to trace and authenticate their products so that claims arising from customer complaints and product performance liabilities, in particular, are proved. The probable nightmare scenario to a pharmaceutical company is where deaths are reported in the international media and attributed to its product—and it cannot prove conclusively that the product was not its own but a pass off. To the best of the author s knowledge this has not happened yet. 

An invitation to join a pharmaceutical company, which is not given lightly, represents an opportunity to join a complex, cooperative enterprise. Within it, synthetic and medicinal chemists are not optional but indispensable, and their role has been likened to a mother s The chemist gives birth to the drug [italics added], but the [physician] supports its first steps (attributed to Foumeau by A Maurois)." Indeed, the labor of birthing drugs can earn not only a chemist s salary but a clinician s respect. 

There are examples where an ERP implementation has been attributed with the failure of a pharmaceutical company [1]. More often, a poor implementation can leave residual problems which severely strain a company s operations for a considerable period following "go live". Getting the implementation right is vital for the business, and getting the validation right is aucial to allow the business to operate. 

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