Looking first at the Consequences of unreliable or untrustworthy data for the client, customer or patient; in the pharmaceutical industry quality control testing is the final stage at which nonconforming products can be detected.
Consequences for the Patient
If the laboratory data is unreliable there is the very real danger that substandard and adulterated products could be delivered to the consumer.
This could result in patients:
- Receiving the wrong medication
- Receiving the wrong dose
- Receiving a medicine that is contaminated with other drug substances or degradation products of the drug or other objectionable substances
- This could result in serious health issues for the patient and even death
Quality Control Testing
The remarks regarding quality control testing being the final opportunity to identify substandard item also applies to any other consumer or industrial product for which quality control testing is carried out.
The Case of Annie Dookham
In the case of the Massachusetts Forensic Drug Laboratory it has been estimated that over 40000 criminal drugs trials have been compromised by Mrs. Dookham’s wrong doing alone. It has even been suggested that every conviction which the Drug’s Laboratory was involved in could be unsafe, due to the laboratory’s lax quality assurance practices. In which case the number of cases affected could be as high as 190000. All these cases may have to be reviewed at a cost of many millions of dollars.
