PLANNING FOR DRUG PRODUCTION
The manufacturers of drugs are required to ensure that they follow specific rules and methodologies for consumer safety purposes. The Food and Drug Administration solely regulates them. FDA ensures that all the manufacturers follow the current good manufacturing practices that are the least standards that should be met in the production of drugs (Kaliaev, & Malikova, (2019). The current good manufacturing practices are meant to ensure that the information the manufacturers give to the consumers of their products is accurate.
The company is a start-up that should ensure that it meets all the essential regulations by FDA concerning cGMP so that they are not involved in conflicts with the authorities. When planning to manufacture a drug, one should put in place the following key steps: first, the company should ensure that the manufacturing process has been well stated and other vital means are not left out. The above is to ensure that there is always consistency in drugs produced (Lamb, (2019). The records of the produced batches must be well controlled. For any changes that can be made to the production process, they have to get evaluated to ensure that they will not affect the quality of the drugs.
The production instructions must be written and in a language that is easily understood by the employees taking part in the production process. The company must hire employees that have the relevant skills. The employees should be well trained for quality control and documentation. The company must consider a well-defined drug distribution process. There must be a well-laid procedure for recalling products from the market, and the quality of products should be tested before sending them to the market (Bowser, T. J. (2019). The consumer complaints are very crucial for the company should document them well and ensure they are well catered. To come up with a plan that complies with cGMP, I will put into account the above steps and procedures.
References
Lamb, C. C. (2019). How Should Start-Up Biotechnology Companies Manage Learning and Generate the Necessary Knowledge to Achieve an Alliance-Based Stage of Growth?. Journal of Commercial Biotechnology, 25(1).
Kaliaev, A. O., & Malikova, M. A. (2019). Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products in Changing Global Regulatory Environment. Therapeutic Innovation & Regulatory Science, 1-11.
Food Processing Facility Design. In Handbook of Farm, Dairy and Food Machinery Engineering (pp. 623-649). Academic Press.