In general, validation is confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled.
The FDA’s Definition of Process Validation it is
The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
The key point in both of these definitions is consistently as a process that cannot deliver a product meeting predetermined specifications is not a validated process.
If you are experiencing more that 3 to 4 percent product failures, you should be questioning whether you are in control of all the critical parameters.
Patient Safety and Product Quality
There are a number of areas that need to be validated, as a general rule of thumb anything that can affect patient safety or product quality should be validated including the following.
- Processes such as manufacturing processes that produce a product.
- Manufacturing Steps each step may be validated separately for long processes.
- Analytical test methods for raw materials, intermediates, active pharmaceutical ingredients and finished pharmaceutical products. In addition, method used for stability studies, which need to be stability indication, and those methods used in Quality Control.
- Systems and programs including those that support GMP process, such as, the facility (building specifications), utilities, programs such as pest control, software, hardware such Enterprise Resource Platform and Laboratory Information Management Systems and Water for Injection.
- Facilities in particular the rooms, facilities and equipment that used for processing products that are sterile must adhere to strict criteria and be validated before use.
- Cleaning processes including sterilize in place and clean in place.