System validation timeline

System validation is actually a process that includes a number of tasks along a specific timeline. This is best shown via the flow chart in Figure I. 

Following risk assessment, the next step is to draft a formal validation plan. This is a written plan that includes all the specific validation procedures, installation tasks, acceptance testing, documentation requirements, reviews and verification tasks that need to be followed for proper system validation. The plan should also define individual responsibilities for these tasks and include an expected timeline. The plan should be designed around the URS and take into account the risk assessment determinations performed earlier. 

Instrument qualification is an important element of laboratory validation. Suppliers s (retrospective) validation plans help with the equipment qualification process. Nowadays the regulatory compliance needs of industry on a global basis are well understood by the instrument vendors. For example, Duncan et al. [118] have illustrated the validation chain for benchtop LC-MS systems and Maxwell et al. [119] have applied the validation timeline to HPLC system validation. Both FDA and USP require that the proper operation of an HPLC system must be validated through a formal calibration program. The components of an HPLC that require calibration include pumps, pump mixing elements, auto-injector, detector, and column heater. 

Following successful completion of the pre-installation process, it is time for the system to be installed and to implement the core of the validation protocol—the IQ/OQ/PQ. Based on the overall timeline, these procedures have been grouped into two task groups upon installation and pre-installation. Focusing on the upon installation tasks, these include both the IQ and OQ protocol, implemented in respective order. They can be generally defined as follows ... 

The main disadvantage of a continuous system is the long time required for validation and timely submission of produet applieation to the appropriate regulatory agency. This timeline is drastieally redueed with the use of a batch system of equivalent volumetric productivity. 

We continue to find proposed timeline to complete validation of the XXXX system to be unacceptable. The XXXX system should not be in use unless they have been completely validated to current standards. [FDA Warning Letter, 2002]... 

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