Validation plan timeline

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. 

As process validation requires significant additional samples, over and above those required for typical QC in-process and release testing, a comprehensive sampling plan is required. In addition to total numbers of samples, the sample container, the storage temperature, the analytical testing and testing timelines should be agreed and documented. 

This request was necessary due to the unusual nature of the timeline. A delay of a year and three months from sample collection to validated results is unusual, even for the AUES. Another delay of eight more months until the regulators and at least one property owner were notified is another inexplicable circumstance. Finally, the Report states in the first sentence, In accordance with the revised Final Work Management Plan for Follow-on Sampling for OU-4 Residential Lots, Amendment 2 (Parsons, April 2001), Parsons (a leading environmental remediation firm) collected soil samples from four OU-4 residences to assess for the presence of the American University Experiment Station (AUES) list of chemicals. The District must know how samples collected in February 2001 could be in accordance with a plan amended in April 2001. 

This chapter highlights the important aspects of the analytical transfer processes as they relate to process, compliance, analytical data, and documentation. Types of method transfers and the timeline of transfer activities are discussed. The risk assessment prior to initiation of transfer activities is also described. The chapter describes content and utility of the transfer protocol and final report, as well as documents that govern analytical method transfers (i.e., SOPs and master plan). The importance of selecting appropriate method transfer acceptance criteria and use of statistical methods to evaluate results are described. The significance of the inclusion of an adequate level of detail in the methods, protocol(s), and other documents cannot be overly stressed. Last of all, the process for transfer of technical ownership of the analytical methods is discussed. Other chapters in this text should be consulted for elaboration on the various important facets of technical transfer, including method development, method validation, documentation, and stability. 

---