The food and drug administration plays an important role in production of quality products because it regulates pharmaceutical manufacturing facilities. FDA inspect and evaluate the company’s status with the regulations and identify the issues those can affect the quality of products and harm the patients.
For companies regulated by FDA, preparing for audits is a regular task because these days FDA do surprise audit without any prior information. In this article we will discuss some best practices for FDA inspection compliance that you can implement in your organization to prepare for FDA inspection.
One of the most important requirement is implementation of quality management system (QMS) that means there should be a system to implement the policies and procedures to ensure that the products manufactured by the company are safe and effective. A QMS system must have the system to implement the risk management and corrective and preventive actions.
It is also required to comply wth regulatory guidelines for documentation, record maintenance, area and equipment labeling. Documents must be up to date and error free as per current guidelines. Data integrity must be maintained as per the guidelines. If any company full fill these all requirements, then it provides evidence of regulatory compliance.
For companies regulated by FDA, preparing for audits is a regular task because these days FDA do surprise audit without any prior information. In this article we will discuss some best practices for FDA inspection compliance that you can implement in your organization to prepare for FDA inspection.
Importance of FDA Compliance
Before we move forward to the best practice for compliance it is important to understand the importance of compliance. Compliance with regulations is a guarantee for quality and safety of the drug products. It shows that products are safe and effective. While non-compliance can have serious problems like product recall, regulatory actions, and it can also damage the company reputation. Noncompliance can create serious issues with public health by allowing the substandard products to enter in the market.Regulatory Requirements
There are a lot of FDA regulatory guidelines available to implement in a pharmaceutical company but there are some key requirements those must comply.One of the most important requirement is implementation of quality management system (QMS) that means there should be a system to implement the policies and procedures to ensure that the products manufactured by the company are safe and effective. A QMS system must have the system to implement the risk management and corrective and preventive actions.
It is also required to comply wth regulatory guidelines for documentation, record maintenance, area and equipment labeling. Documents must be up to date and error free as per current guidelines. Data integrity must be maintained as per the guidelines. If any company full fill these all requirements, then it provides evidence of regulatory compliance.
Related: 5 Most Common 483s in FDA Inspections
Improper documentation is the most common finding. Inspectors will review the document to ensure that these are accurate and up to date with the regulatory guidelines. Documents related to the manufacturing, testing and storage must comply with the regulatory norms.
Facility maintenance is another major finding during FDA inspections. Facility must be well maintained including equipment maintenance, cleanliness, pest control and sanitization. Toilets must be cleaned and well sanitized.
Employ training is also a frequently occurring issue during FDA inspections. Inspectors will review training records of employees of all departments to ensure that the employees of the companies are well trained for the work they are doing. All training programs must be documented in the training records.
1. Developing a Quality Management System: As I have mentioned before a good quality management system is primary requirement of the regulatory compliance. Companies should develop a strong quality management system to control the documents risk management, quality policies, CAPA implementation and procedures. And QMS should not only to be developed but it should also be implemented properly.
Common Inspection Findings
During the inspection, FDA inspectors will evaluate the compliance with the FDA regulations and try to find the issues those can affect the quality of the product. The finding of inspection may vary with companies and inspectors but following are the common findings that you should aware.Improper documentation is the most common finding. Inspectors will review the document to ensure that these are accurate and up to date with the regulatory guidelines. Documents related to the manufacturing, testing and storage must comply with the regulatory norms.
Facility maintenance is another major finding during FDA inspections. Facility must be well maintained including equipment maintenance, cleanliness, pest control and sanitization. Toilets must be cleaned and well sanitized.
Employ training is also a frequently occurring issue during FDA inspections. Inspectors will review training records of employees of all departments to ensure that the employees of the companies are well trained for the work they are doing. All training programs must be documented in the training records.
Best Practice for Compliance
Company must follow some key practices for FDA inspection and ongoing compliance with FDA regulations. Following best practices must be implemented to comply with regulatory guidelines.1. Developing a Quality Management System: As I have mentioned before a good quality management system is primary requirement of the regulatory compliance. Companies should develop a strong quality management system to control the documents risk management, quality policies, CAPA implementation and procedures. And QMS should not only to be developed but it should also be implemented properly.
Related: FDA 483 Observations Related to Cleaning in Pharmaceuticals
2. Up to Date Documents: Documents must be accurate and updated with the current regulatory guidelines. Documents related to the manufacturing and testing must be maintained with raw data and it should be readily available on demand.
3. Conducting Internal Audits: Internal audits are self-inspections that company conducts itself. Internal audits must be conducted at regular intervals. Internal audit must be conducted by the experienced employee who can find the issues and should not be from the same department that is being audited. The findings of the internal audits should addressed through the CAPA and problems should be rectified immediately.
4. Employee Training: Training of employees is very important for FDA compliance. Training to the employees must be given for their respective job at the time of joining and at different intervals or any change in procedure or process. Training record must be maintained for every employee and it should be reviewed regularly to ensure that the employees are properly trained for the work they are doing.
5. Conducting Mock FDA Inspection: Companies should conduct mock FDA inspection regularly to give experience of an actual FDA inspection to the employees. It will help the employees to become familiar with the FDA inspections. Moreover, this will help to find the potential non-compliances and issues before the actual FDA inspection.
Compliance with FDA regulations is a challenging task for companies but by implementing these practices for regulatory compliance, companies can prepare for regulatory audits and maintain ongoing compliance to produce safe, effective, and better-quality pharmaceutical products.
2. Up to Date Documents: Documents must be accurate and updated with the current regulatory guidelines. Documents related to the manufacturing and testing must be maintained with raw data and it should be readily available on demand.
3. Conducting Internal Audits: Internal audits are self-inspections that company conducts itself. Internal audits must be conducted at regular intervals. Internal audit must be conducted by the experienced employee who can find the issues and should not be from the same department that is being audited. The findings of the internal audits should addressed through the CAPA and problems should be rectified immediately.
4. Employee Training: Training of employees is very important for FDA compliance. Training to the employees must be given for their respective job at the time of joining and at different intervals or any change in procedure or process. Training record must be maintained for every employee and it should be reviewed regularly to ensure that the employees are properly trained for the work they are doing.
5. Conducting Mock FDA Inspection: Companies should conduct mock FDA inspection regularly to give experience of an actual FDA inspection to the employees. It will help the employees to become familiar with the FDA inspections. Moreover, this will help to find the potential non-compliances and issues before the actual FDA inspection.
Compliance with FDA regulations is a challenging task for companies but by implementing these practices for regulatory compliance, companies can prepare for regulatory audits and maintain ongoing compliance to produce safe, effective, and better-quality pharmaceutical products.
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