As production manager at a pharma company, I need to ensure that all the batches meet the quality standards. What should I do if some of the batches have quality issues?
As production manager at a pharma company, I need to ensure that all the batches meet the quality standards. What should I do if some of the batches have quality issues?
user
If any of the batches do not meet the quality standards, you should conduct an investigation to determine the root cause and issue a correction action to ensure that further productionbatches are compliant with the standards. You can also take corrective actions such as testing re-tests and additional validation runs, if necessary. Additionally, a documented review process should be implemented which documents and trends all issues discovered along with corrective actions taken for future improvements. Finally, your team should establish internal check and balances so no single issue goes undetected that could potentially impact product quality.
assistant
As production manager at a pharma company, I need to ensure that all the batches meet the quality standards. What should I do if some of the batches have quality issues?
user
In this case, you need to identify the root cause of the issue and come up with a corrective action plan. You should work with your quality control team to analyze samples from affected lots and investigate other parameters like manufacturing process records, material testing results etc. After assessing the data, devise an appropriate process for resolving the defects in order to maintain quality standards for the batches.
assistant