Validation For FDA & ISO 13485

Meeting the requirements put in place by the FDA for validation can be challenging, if not confusing.  Validation, as defined by FDA’s Guideline on General Principles of Process Validation, is “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”  The Code of Federal Regulations (CFR’s) for medical devices require both design and manufacture processes be validated.  This includes the tools used to create the product.  The process consists of three steps: identification, risk assessment and testing.

ControTek has developed a standardized validation process that meets CFR requirements and enhances product value.  The first step for tool or process validation is to identify all items requiring validation.  Validation can include the specific medical device, but is also required for development tools (e.g. – compilers), software (CAD, ERP, etc.), manufacturing processes and production tools (ovens, cleaners, test systems, etc.).  A key factor to consider is how much validation is required for each item.  Validation requirements should be different depending on the risk associated with the item.  A valuable tool to determine risk factors is FMEA (Failure Mode Effect Analysis).  This tool/techniques will quickly highlight areas that require attention and can better focus the validation process.

After identification and risk assessment, the product/process validation test parameters are defined.  Parameters will vary depending on the type of validation, but each test should be focused on addressing potential risks.  A recent validation at Controltek for an in-line cleaner identified the process variables (temperature, pressure, speed and incoming resistivity, etc.) and utilized a Design Of Experiments (DOE) to determine the critical variables.  With this information and system risk analysis, formal controls were established to ensure process compliance as part of the validation.  While this effort took significant time and effort, the validation identified solid controls to insure product quality.

Since validation can take considerable time and effort, being thorough and efficient can be a challenge.  A potential work saving method is to contact a tool, equipment or process provider associated with the product to determine if they have already performed some validation.  Even if formal validation for medical requirements has not been conducted, the vendor is a good resource for risk assessment and prior test data that can save valuable time.

The only caveat to the validation process is that it is never over.  Certain high risk processes may require recurring validation efforts and validation activities need to be re-conducted after design or production process changes.  Even though validation can be a challenge, the end result should be reduced risk and higher quality.

Good resources for validation are:

www.fda.gov/cder/guidance/pv.htm

www.medicaldesign.com/articles/id/12555

www.devicelink.com/pmpn/archive/01/11/022.html

www.cfpie.com/showitem.aspx?productid=089

www.wikibiopharm.com/index.php?title=validation