Pharmaceutical manufacturers have to make sure their validation program covers all the important areas of pharmaceutical processing. The major areas include:
- Equipment validation (also called qualification).
- Facilities and utility validation (water system, air handling unit, compressed gas system, computer systems).
- Process validation.
- Cleaning validation.
- Analytical method validation.
- Instrument calibration.
Validation needs to be carried out for any new equipment,
premises, utilities, systems, procedures, or processes. It must also be
performed when any major change has occurred in any of these. Validation is
different from in-process tests – the latter only helps in monitoring that a
process runs as expected, whereas validation aims at demonstrating that a given
process is suitable for routine use because it consistently yields a product of
desired quality. In this sense, validation activities will focus on the most
critical aspects of processes, and these are arrived at through a risk
assessment approach.
Advantages of Validation
- Optimized processes.
- Assured quality of products.
- Reduced cost of maintaining quality.
- Increased output.
- Reduced complaints, rejections, batch failure, mix-ups, and cross-contamination.
- Faster scale-up from pilot level to manufacturing level.
- Better compliance with regulatory requirements.