What happens when a capsule (medicine) appears broken or is of low quality? It immediately leads to many discussions about the discrepancies at the production unit, irresponsibility of people involved, and eventually leads to batch recall which tarnishes the image of the company. Such incidents can have devastating effects on companies and their employees. Therefore, pharma industries need to follow many stringent rules and regulations to meet compliance standards. Moreover, the industry involves huge investment and one slight mistake can lead to a total recall of the product which in turn leads to a massive loss. It is always better to perform thorough checks on the 4M which stand as pillars of the pharma industry and ensure to do it right for the first time.
What are 4M and their importance?
4M stands for Man, Machine, Method, and Material involved in the production of the medicines in a pharma company. Let’s see how these are important in the pharma sector.
Man – It is very essential to see that the person involved in any stage of the production is qualified to carry on the responsibilities appropriately. Their qualifications and skills should be validated from time-to-time.
Machine – The machine which is involved in the production should be properly checked and calibrated at the pre-defined schedules to ensure there is no error or discrepancy in production.
Methods – The methods to be followed for producing medicines are also pre-determined. All we need to do is follow them step-by-step without any deviations or changes.
Materials – Finally, the material which is consumed for production purpose also needs to be thoroughly scrutinized, analyzed and validated. Managing all these 4Ms helps in avoiding unnecessary expenses.
What does “Do it right the first time” concept mean?
“Do it right the first time” means exactly what the words say. It means that we need to be cautious in checking all the 4Ms involved in the production of medicines from the first time itself that helps in avoiding unwanted errors and issues. If the pharma sector is provided with tools that help in taking all the appropriate steps before, during and after production, there would be no chance for deviations, changes, errors and ultimately losses.
Why should we follow that concept?
The concept of “do it right for the first time” helps in procuring good reputation for the company. If the 4Ms are not taken good care of, the issues arising out of it will be time-consuming, resource-consuming and expensive to deal with. Therefore, if any pharma company decides to spend at least 10% of investment in taking care of the 4Ms at the beginning itself, the number of issues arising can be minimized to the greatest extent.
How is it related to 6 Sigma?
“Do it right the first time” concept is considered as the first step of 6 Sigma that leads to assured profits for any company. 6 Sigma is actually a set of proven techniques and tools that aid in process improvement. This concept applies to the pharma sector too as it helps the pharma companies evolve and get things sorted. If essential care is taken to do things appropriately for the first time every time, then it will lead to good production every time which is what any company would aim for.
How does CaliberLIMS help?
CaliberLIMS is the only product that can help the pharma companies follow the “Do it right the first time” concept efficiently and effectively. In other words, it is a pioneer feature of CaliberLIMS product.
Man – The training management module will not let any trainee who is not appropriately trained in a skill to be picked for work if he/she is out of trained status validity analysis. It helps in picking the right man for the right work.
Materials – As the chemicals’ details are fed in CaliberLIMS software during the procurement stage, any chemical that is expired will not show up in the list of available chemicals for production. Therefore, the chances of such grave errors will be less. Instrument calibration is work is completed and details fed into the CaliberLIMS software before engaging in production activity.
Machine – If the instrument is out of calibration or not appropriately calibrated on the assigned date, the machine doesn’t reflect in the list of instruments available for production. This can help in taking necessary steps on the time such as calibrating the instruments as well as avoid losses caused due to instrument malfunction.
Method – Further, the CaliberLIMS product complies with all the existing STPs, SOPs and specifications. Therefore, the system doesn’t permit the use of an incorrect method.
Thus, CaliberLIMS will help in sticking and following stringently the most important concept of “Do it right the first time.” It not only helps in increasing the revenue and reducing the costs by avoiding errors but also in improving the credibility of the pharma company in the pharma sector.