Do it right the first time is an important concept in pharma sector. It is a pioneer feature of Caliber products. Pharma companies need to follow many stringent rules and regulations during production. As medicines and life-saving drugs are their end products, they need to meet compliance standards always. The industry involves huge investment. Any case of total recall of the product leads to a massive loss. Therefore, it is always better to perform thorough checks on the 4Ms which stand as pillars of the pharma industry. As a result, pharma companies will be able to do it right the first time, every time.
4Ms stands for (Wo)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.
(Wo)Man: It is very essential to see that people involved in any stage of the production are qualified. They should be able to carry on their responsibilities appropriately. Their qualifications and skills should be validated from time-to-time.
Machine: The machine involved in production should be properly checked and calibrated at pre-defined schedules. It ensures that there is no error or discrepancy in production.
Methods: The methods to be followed for producing drugs, etc. are also pre-determined. All we need to do is follow them step-by-step without any deviations or changes.
Materials: Finally, the materials which are consumed for production purpose also need to be thoroughly scrutinized, analyzed and validated.
Managing all these 4Ms helps in avoiding unnecessary expenses.
“Do it right the first time” means that we need to be cautious in checking all the 4Ms involved in the production from the beginning. It helps in avoiding 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.
The concept of “do it right the first time” helps in procuring a good reputation for the company. If not, 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 inception time, the number of issues arising can be minimized to the greatest extent.
“Do it right the first time” concept is the first step of 6 Sigma that leads to assured profits for any company. 6 Sigma is 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. If essential care is taken to do things appropriately the first time every time, then it will lead to good production and profits.
Caliber products can help the pharma companies follow the “Do it right the first time” concept efficiently and effectively every time.
(Wo)Man: The training management module will not assign work to any trainee who is not appropriately trained or is out of trained status validity analysis. It helps in picking the right man for the right work.
Materials: As the chemicals’ details are updated in Caliber products 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 grave errors like using expired chemicals in production will be minimized.
Machine: Instruments are calibrated and details are updated into the software application before engaging in production activity. If the instrument is out of calibration or not calibrated on the assigned date, the machine doesn’t reflect in the list of instruments available for production. Thus, it helps in avoiding losses due to instrument malfunction.
Method: Caliber products comply with all the existing STPs, SOPs and specifications. Therefore, the system doesn’t permit the use of an incorrect method.
Caliber products help in following the most important concept of “Do it right the first time” stringently. It aims at increasing revenue and reducing the costs of companies by avoiding errors. It also paves way for improving the credibility of a particular pharma company in the pharma sector.