Revalidation

Revalidation is essential to ensure that any changes made to the process or its environment have not adversely affected product quality or process characteristics. It can be divided into two sub-types:

✔ Review after changes – Whenever you introduce any new material into the production process, they need to be reviewed to ensure their effects. There can be many changes in manufacturing or standard operating procedures that affect product quality. These can be:

✔ Changes in starting materials – Changes in physical properties can alter the mechanical properties of compounds and materials, which in turn can adversely affect the product or process.

✔ Change in packaging material – If you change the packaging material, you may be forced to change the procedure followed during packaging, which may affect the product’s durability.

✔ Changes in Process – Any time you change the manufacturing process, subsequent steps can be affected and thereby the quality of the product.

Equipment changes – Repair, maintenance and replacement of key components are inevitable, but be sure to assess whether and to what extent quality is affected.

✔ Changes in support systems or production areas – Reconfiguration of support systems or production areas can also affect product quality, especially critical systems such as ventilation.

Periodic recalibration Similar to routine maintenance, calibration, and other key requirements, recalibration at scheduled intervals helps you ensure that your system and tests are performing within required standards.

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