What is Pharma Compliance?
Pharmaceutical Compliance plays a critical role when it comes to pharmaceuticals and their use. The chief reason for its importance is to ensure the health and safety of those who use the products. Pharmaceutical science is very exact and when there is any type of noncompliance, disaster can ensue. There have been many reported instances of patients who have died due to receiving a wrong medication or the wrong dosage of the right medicine. Most of the time, these incidences can be attributed to the lack of pharmaceutical compliance.
What exactly is pharmaceutical compliance?
There are certain standards and rules for specifications in place which must be followed when dealing with pharmaceuticals. Pharmaceutical compliance is a state of being in accordance with these prescribed rules and guidelines. There are standards which are set forth by different regulatory bodies on both a national and international level. These are not just arbitrary standards or guesses at how pharmaceuticals should be handled; they have been carefully considered and arrived at after many years of contemplation. All of the regulations which are in regard to pharmaceutical compliance are based on scientific facts. Some of the best brains in science and the industry have come together to create a set of standards which is universally acceptable. To arrive at this point, it has taken years of intense and active study. Finally, there is a set of common international guidelines and regulations which have been put into place by regulatory bodies.
How is pharmaceutical compliance achieved?
Different regions around the world have their own regulatory compliance agency that oversees the implementation of pharmaceutical compliance. Of course, there are varying regulations in different countries, but the main standards are common to all. For instance, in pharmacopeia in the US, Britain or Japan may be somewhat different as far as measurements but the underlying principles are all the same. Even though the dosages can vary, the proportion that is recommended would be universally agreed on. This is part of pharmaceutical compliance.
Are there specific international standards regarding pharmaceutical compliance?
There are some variants in the standards from around the world. The International Conference on Harmonization (ICH) sets out a series of standards and most of the nations around the world agree and comply. Pharmaceutical compliance in US and the standards prescribed by the FDA are based on the ICH.
What would happen if pharmaceutical compliance did not exist?
There can be some very negative consequences that come from not being in pharmaceutical compliance. Some of the problems that might arise from lack of compliance are:
· Ineffectiveness of medications: Medicine might not serve its desired effect.
· Patients would suffer needlessly: This is particularly true for high specialty drugs like those used for cancer or cardiology. Drugs which are not in pharmaceutical compliance could cause ill effects and could even cause the death of a patient.
· Loss of large amounts of money: When an organization is out of pharmaceutical compliance, they are at a very high risk of incurring losses which are simply incalculable. They could lose money from the negative reputation they would eventually be given by consumers; and they could have to pay out for some very expensive lawsuits which could be damaging to the company.
Compliance Teams can Strengthen Pharmaceutical Compliance
Every year noncompliance costs the industry literally billions of dollars in recalls, audits and fines alone. In order to avoid these types of penalties or missteps, companies develop compliance teams which monitor a product from the time it is conceived. Compliance teams face some very difficult challenges even though they do a critically important job. They have to keep up with the fast pace of the ever changing international and national standards. It can be difficult to find the perfect balance between over compliance and under compliance. And the team also has to keep other employees up to date on the latest changes in policies and regulations. In order to do this effectively, they must also provide adequate training for employees so that they can avoid any compliance issues which can be costly. Compliance teams have to be familiar with a number of laws, guidelines and regulations from around the world. This complicated practice is necessary to ensure pharmaceutical compliance and patient’s safety.
What exactly is pharmaceutical compliance?
There are certain standards and rules for specifications in place which must be followed when dealing with pharmaceuticals. Pharmaceutical compliance is a state of being in accordance with these prescribed rules and guidelines. There are standards which are set forth by different regulatory bodies on both a national and international level. These are not just arbitrary standards or guesses at how pharmaceuticals should be handled; they have been carefully considered and arrived at after many years of contemplation. All of the regulations which are in regard to pharmaceutical compliance are based on scientific facts. Some of the best brains in science and the industry have come together to create a set of standards which is universally acceptable. To arrive at this point, it has taken years of intense and active study. Finally, there is a set of common international guidelines and regulations which have been put into place by regulatory bodies.
How is pharmaceutical compliance achieved?
Different regions around the world have their own regulatory compliance agency that oversees the implementation of pharmaceutical compliance. Of course, there are varying regulations in different countries, but the main standards are common to all. For instance, in pharmacopeia in the US, Britain or Japan may be somewhat different as far as measurements but the underlying principles are all the same. Even though the dosages can vary, the proportion that is recommended would be universally agreed on. This is part of pharmaceutical compliance.
Are there specific international standards regarding pharmaceutical compliance?
There are some variants in the standards from around the world. The International Conference on Harmonization (ICH) sets out a series of standards and most of the nations around the world agree and comply. Pharmaceutical compliance in US and the standards prescribed by the FDA are based on the ICH.
What would happen if pharmaceutical compliance did not exist?
There can be some very negative consequences that come from not being in pharmaceutical compliance. Some of the problems that might arise from lack of compliance are:
· Ineffectiveness of medications: Medicine might not serve its desired effect.
· Patients would suffer needlessly: This is particularly true for high specialty drugs like those used for cancer or cardiology. Drugs which are not in pharmaceutical compliance could cause ill effects and could even cause the death of a patient.
· Loss of large amounts of money: When an organization is out of pharmaceutical compliance, they are at a very high risk of incurring losses which are simply incalculable. They could lose money from the negative reputation they would eventually be given by consumers; and they could have to pay out for some very expensive lawsuits which could be damaging to the company.
Compliance Teams can Strengthen Pharmaceutical Compliance
Every year noncompliance costs the industry literally billions of dollars in recalls, audits and fines alone. In order to avoid these types of penalties or missteps, companies develop compliance teams which monitor a product from the time it is conceived. Compliance teams face some very difficult challenges even though they do a critically important job. They have to keep up with the fast pace of the ever changing international and national standards. It can be difficult to find the perfect balance between over compliance and under compliance. And the team also has to keep other employees up to date on the latest changes in policies and regulations. In order to do this effectively, they must also provide adequate training for employees so that they can avoid any compliance issues which can be costly. Compliance teams have to be familiar with a number of laws, guidelines and regulations from around the world. This complicated practice is necessary to ensure pharmaceutical compliance and patient’s safety.