An understanding of pharmaceutical compliance
Pharmaceutical regulatory compliance, or just pharmaceutical compliance, is a critical area of pharmaceuticals. Why? This is because pharmaceutical science is very exact and extremely important for people’s health. If there is noncompliance in the pharmaceutical industry, the result can be disastrous. There have been many occasions when patients have died because of wrong medication or wrong dosage. In most cases, this can be attributed to lack of pharmaceutical compliance.
What is it that makes pharmaceutical compliance so important? What is it in the first place, and what is needed to be in compliance?
What is pharmaceutical compliance?
Pharmaceutical compliance is the state of a product being in accordance with prescribed rules for specifications and standards. These standards are set out by various regulatory bodies, both national and international. These standards have been arrived at after years and years of thought. No regulation regarding pharmaceutical compliance is arbitrary or unscientific.
These standards are arrived at after the best brains have come together to set standards that are universally acceptable. This compliance is enacted to ensure that products are effective and produce the desired effect. The setting of these standards takes several years of active and intense study to get implanted into a common international system which is put in place by regulatory bodies.
How can pharmaceutical compliance be achieved?
Regulatory bodies oversee the recommendation and implementation of pharmaceutical compliance. Obviously, there are bound to be different pharmacopeia (the science of measurement of medical products) for different countries, but the underlying standards are common. For instance, we could have United States pharmacopeia (USP), British Pharmacopeia (BP) or Japanese Pharmacopeia (JP), but the underlying principle behind the measurements is common. Each dosage could vary, but the proportion of the recommended medication for the dosage is universally agreed upon,and is part of compliance.
Which are the international standards for pharmaceutical compliance?
Some of the standards currently in place around the world are the variants of the ICH, such as series of standards set out by the International Conference on Harmonization (ICH), such as ICH-Q7A and the ICH Q10, the ISO, FDA-prescribed standards and the standards set out by individual countries.
What happens if there is no pharmaceutical compliance?
The consequences of not being in pharmaceutical training are obvious. As we have just seen; not being in compliance with regulations set out by regulatory authorities can have serious consequences. These are some of the problems that could arise if there is lack of compliance:
o The medicine could be ineffective: This could mean that the medicine would not be serving its desired effect. As a result, all the trouble the medical fraternity and the patient takes would come to naught.
o The patient could suffer: When it comes to high specialty drugs such as cardiologic or cancer or drugs that act on the autoimmune system or the central nervous system; drugs that don’t have the necessary regulatory compliance can cause ill-effects that can go up to the level of causing death to the patient.
o It could result in loss of huge amounts of money: An organization that does not show compliance is at extremely high risk of incurring incalculable losses. First, it could end up losing money when consumers start distrusting its reputation and doubt its ability to deliver an effective product. Next; it could lose large amounts of money in expensive lawsuits that could pull its name down and cause it the kind of damage that it will possibly never recover from.