Are you taking stress over getting an FDA 483 letter? It’s very common as you are not alone in this. The pressure of Regulatory Compliance in the
Let’s take a look at the top three compliance issues and how you can resolve these issues:
Lack of Written Procedures and SOPs
In a Standard Operating Procedure (SOP), clear stages are outlined for completing specific tasks in the workshop. Proper utilization of SOP improves communication and makes it easier to perform the necessary tasks for the work to move ahead. However, compliance issues tend to arise due to a lack of effective SOPs/Written Procedures. In addition, different issues prevent creating and using SOPs, including complicated language, lack of standardization, and inadequate training.
Poor Maintenance Facilities
Most of the FDA observations were for inadequate cleaning, sanitizing, and maintenance; they must have to comply with the FDA Code of Federal Regulations appropriately. The company should clearly outline the methods for cleaning and maintaining hygienic conditions. For example:
- Providing clear instructions for cleaning.
- Indicating who is responsible.
- Planning your cleaning schedule.
- Providing the guidelines for maintaining the equipment properly.
- Ensuring regular inspections and protective measures for equipment.
In addition, it is important to maintain cleaning activities logs and update them as often as other operational logs.
Improper Use of Data
Real-time access to data allows pharmaceutical companies to stay in the direction of changes in compliance and improve performance. With proper data, an organization can minimize the effects of non-compliance effectively. Unfortunately, one of the key reasons that organizations cannot utilize the available data is old technology.
By implementing Pharmaceutical ERP, pharma companies can track and trace real-time data and can reduce the effect of non-compliance. Implementing
Pharma ERP Partner,