Three Simple FDA CAPA Tips to Assure Compliance

Three Simple FDA CAPA Tips to Assure Compliance

September 10th, 2013 // 3:38 pm @

Latest FDA and cGMP Compliance News

FDA investigators often focus on CAPA (corrective and preventive actions) procedures during a quality inspection because it is a good road map to ID existing problems at your company. Your firm’s CAPA documentation gives investigators and managers a way to go over and review problems. So, effective CAPA management is essential to your organization’s overall FDA compliance. If you follow our five simple tips below, your company will be more likely to be fully CAPA compliant in the eyes of FDA.

1. Implement a Strong CAPA System and Document

You might think this is obvious, but you really need to be sure that you do properly establish your CAPA system and fully document all procedures. After all, one of the most common FDA 483 observations is failing to have a CAPA system or not having CAPAs documented. In fact, not having a documented CAPA system was the #2 most common observation for FDA auditors in 2010. And, CAPA was noted in more than 50% of all warning letters in 2009.

Not having a CAPA system can be because the company does not know FDA or EU requirements, or due to the regulatory status of the product. Or sometimes not having a CAPA system happens in a mature quality system. This might happen when you are relying on a contracting company, or you did not properly integrate a company recently acquired into your quality system. If you are acquiring a company, you need to be sure that any lack of CAPA procedures in that company have been identified.

2. Analyze Data on Quality With Statistical Methodology to Find Quality Issues

You should review all of this quality data:

  • Process
  • Work operations
  • Quality audit reports
  • Quality records
  • Service records
  • Complaints
  • Returned product

You should choose data sources that are both inside and outside the company. You also should watch to ensure that attention is paid to quality data on your manufacturing processes and any nonconformances. These types of data show up on FDA warning letters.

You really should pay close attention to product complaints, as they are a very direct sign of problems with products on the market. They should be analyzed through your CAPA system as needed. FDA makes it clear that it sees complaints as a source of CAPA data, and not addressing customer complaints and problems can often get you an FDA warning letter.

Note that FDA auditors often will judge your quality system based upon a CAPA log review. So, you need to implement and then do a recording of all changes in your procedures and methods in your CAPA log. The sheer number of CAPAs can be a bit misleading, but you should note the important role that the log will play during an investigation. You will need to think about addressing small quality problems through a separate process, or to elevate that issue and implement the CAPA process.

3. Investigate and Pin Point Causes of Quality Problems

It is important to quickly investigate the causes of quality problems. FDA notes if your firm did find a problem but did not do a good investigation to see what the root cause was. You should conduct a meaningful investigation by using a highly systematic and orderly process. For example, you should set up an investigation procedure that must be implemented every tie there is a problem. This investigation needs to be done by a trained investigator. You also should use a target dating method for CAPA closure that does triaging which is based upon risk. Any CAPAs that are tied to any nonconforming finished product need to be a top priority.

Be sure to avoid the mistakes that lead to a non-complete investigation. Many firms will use ‘training’ as a cure all and as a scapegoat. FDA will not be pleased if there is not a full investigation that supports your training only solution. Also, jumping to a quick conclusion on what caused a problem without a full investigation also will get FDA looking more closely.

For more information on setting up a proper CAPA system, please refer to our upcoming webinar, How to Design an Effective CAPA Program.





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