FDA Validation

ISO 9001- the series was the most common method up through the 90s and was used to create customer confidence. Confidence from customers is still the most important, but today companies focus on 0-failures philosophy, process optimization and minimization of wastage expressed through LEAN, Six Sigma or FDA validation (0-failures production).

Validation is to avoid failures opposite sorting.

When a company such as exporting food, dietary supplements, cosmetics, medical devices, pharmaceuticals or blood products to the United States, it is a requirement that the manufacturer validates the process to ensure flawless products.

NOTE that this is a legal requirement!

If the manufacturer not complies with this requirement, the FDA (Food and Drug Administration) can go to courts and demand the product removed from the market.

How to set up production to produce without failures?

Any failure freedom begins with product development, because failures and delays can be expected. Parallel to the development of a new product, validation can be carried out to ensure that the initial start-up results in a flawless issue, and the minimum cycle time. Troubleshooting avoided and the subsequent production results in lowest unit cost.

How to realize 0-failures production through FDA-validation?

A plan for process validation consists of 5 basic elements, see the table below:

1 IQ Installation Qualification Prove that production equipment, and other equipment are connected as prescribed and that alle supplies meet specifications. Note that it is not enough to refer to the supplier’s own testing equipment!
2 OQ Operationel Qualification Establish limits for process control that ensures production of approved products.
3 PQ Production Qualification Prove that the process is reproducible, as documented by completing 3 productions. These 3 productions shall be carried out in normally occurring production conditions. (eg. shiftwork). Statistics evidence within 95% confidence
4 PC Process Control (control and monitoring) Process Control, a key part of process validation “process monitoring and real-time process control”. The company must prove that the process is monitored and that there is a valid method to control when monitoring indicates a change. To respond in “real time”, ie. The current production. Collecting data is processed and presented to the operator who   can intervene immediately. Corrections can similarly be automatic when monitoring data are stored as evidence that the process has been in control.
5 ReVal Repetition of Validation Saved data from monitoring should be archived, as evidence that the process produces within specified limits. This will be sufficient evidence for a “renewal” of validation.