Concerned about receiving an FDA 483 letter? It is very common because you are not alone in this. Regulatory compliance pressure in
Let’s look at the top three compliance issues and how you can solve them:
Lack of written procedures and standard operating procedures
In the Standard Operating Procedure (SOP), clear stages are defined for completing specific tasks in the workshop. Proper use of standard operating procedures improves communication and facilitates the performance of tasks necessary to move the business forward. However, compliance issues tend to arise due to the lack of effective written standard operating procedures/procedures. In addition, various problems prevent the creation and use of standard operating procedures, including complex language, lack of standardization, and insufficient training.
Poor maintenance facilities
Most of the FDA’s observations were regarding inadequate cleaning, sterilization, and maintenance; They must comply with FDA law for federal regulations appropriately. The company must clearly define the methods of cleaning and maintaining sanitary conditions. For example:
- Give clear instructions for cleaning.
- Indicating who is responsible.
- Plan your cleaning schedule.
- Provide instructions for proper maintenance of equipment.
- Ensure regular inspections and preventive measures for equipment.
In addition, it is important to keep records of cleaning activities and update them as often as other operating records.
Improper use of data
Real-time access to data allows pharmaceutical companies to stay on top of changes in compliance and improve performance. By using appropriate data, an organization can effectively reduce the effects of non-compliance. Unfortunately, one of the main reasons organizations cannot use the available data is outdated technology.
By implementing a pharmaceutical ERP system, pharmaceutical companies can track and trace data in real time and can reduce the impact of non-compliance. to implement
Pharma ERP Partner,
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