Compliance with cGMP regulations is always a priority and obviously the cost of non-compliance is higher than ‘cost of compliance’. Due to non – compliance, the company not only suffers in fines and loss of business in terms of potential exports but also ruins the image and goodwill it has earned after years of hard work. Hence, it is not only the responsibility of the senior management, but of every individual to make sure that regulations are followed and the necessary requirements are met.
GMP regulations are guidelines to develop systems which ensure that manufacturing facilities and processes are properly designed, monitored and controlled, ensuring that finished products are effective and safe for market distribution. It is time we truly understand the importance of following the guidelines that have been established by the regulatory authorities.
India has become the biggest foreign supplier of medicines to the US. It accounts for nearly 40 per cent of generic drugs and over-the-counter products as well as 10 per cent of finished dosages used in the US. Huge competition in the market and shortage of time are some of the reasons for increasing issues of non-compliance in India. The absence of global harmonisation of quality systems makes it all the more challenging for India as it exports to the US, Europe, Australia, Japan, etc, to comply with a plethora of global regulatory guidelines across diverse geographies and may sometimes fall short of regulatory expectations. With all this, one also has to note that the pharma and excipient sectors are growing at a very fast pace, and it has resulted in shortage of skilled staff at various levels.
Lack of proper training to the existing group of employees is also one of the important issues that arise during GMP audits. It is important that the standard operating procedures (SOPs) are made to exactly reflect the actual processes that are followed and the people involved at the worker level, junior research associate level etc. are aware of the importance of following each step exactly according to the requirement. It is also important that they understand that SOPs are not just documents but guidelines to help them do their work efficiently. Knowledge and understanding of the SOPs and maintenance of log books by writing down every detail will help resolve the issues relating to non – compliance of documentation. These issues can be easily dealt with by designing periodic training programmes, specifically suited to help the individual to effectively perform his assigned duties.
Alternately, the manufacturers also have to understand the long term benefits of investing in trained people and facilities. Help from external quality consultants should be welcome, but it is also important to note they can only point out the areas where change is required. Ultimately, it all circles back to the persons actually involved. A change in attitude is of utmost importance. Once we change our perspective about the situation in question, only then can we bring the necessary changes. With implementation of certain small and concrete steps the issues faced with GMP compliance can be addressed and future mistakes can be avoided.