Validation Reviews

If systems are inappropriately used, the results of those systems are questionable at best. Validation review of a system must include an analysis of proper use and an evaluation of the degree to which normal user behavior falls within those proper use norms. 

Validation estabhshes the credibility of laboratory data and automated procedures. Without a credible validation review it is certainly possible to foUow the GALP guidelines or equivalent industry consensus vahdation provides the proof that those guidehnes are incorporated in daily and ongoing activities. TTie GALPs serve two important proposes they es-tabhsh the agenda for managing an automated laboratory... 

A validation review procedure must be formally defined. Any validation review must be documented in detail and the results of any test should be compared to the original validation results. If the results are satisfactory, the facility or operation may continue to be used. If the results are not satisfactory, operations must be suspended. The facility or operation must be validated before further use. 

The frequency of the validation review should be addressed in the final validation report and may be determined against elapsed time or the number of batches processed, anomalies in results of in-process and end-product testing, and questions arising from internal or external audits. 

A formal validation review should be carried out periodically to determine the necessity for revalidation. 

Have production procedures been validated (Review... 

These resources limitations leave the FDA with some difficult choices. The Agency can, in effect, outsource by increasingly relying on outside expert consultants who provide client companies with reports of compliance audits, validation reviews, chemistry, manufacturing, and control analyses, and the... 

Supporting documentation requirements must be defined for validation reviews. [FDA Warning Letter, 1999]... 

Finally, utility and equipment revalidation or validation review may be structured differently than techniques typically used in the manufacturing environment. Unlike the production facility, the pilot plant may not use every piece of equipment or system on a routine basis. In fact, some equipment may remain idle for significant periods of time. Revalidation may need to be scheduled based on hours in use rather than a program designed for periodic review. It should be pointed out that some equipment or systems might need more frequent revalidation activities because of lack of use. No matter what basis is chosen, it is imperative that a formal revalidation program be established in the pilot plant environment. 

Based on the experience gained during the pilot scale-up effort, a process flow chart should be constructed. It helps identify steps and issues in need of process-validation review. In addition, the timing of activities toward the scheduling of manpower needs. 

Validation project management Validation responsibilities Design and validability review... 

Periodic Review. Periodic validation reviews should be conducted at approximately 12-month intervals. The periodic review has a number of objectives ... 

AR437 1.168 Verification, validation, reviews and audits for digital computer software used in safety... 

Although several reports have appeared on the validation of LC methods for specific pharmaceuticals, one particularly comprehensive study discussed system suitability, peak purity, system resolution, system selectivity, and stability-indicating properties. The example used in this work was the method developed for pipecuronium bromide. A final comprehensive method validation review has also shown the importance of each facet specificity, accuracy, precision, sensitivity, and robustness. 

The overall process of EOP validation and its documentation should be reviewed according to the recommendations in Section 3.6. The review should focus on whether the validation guide has been properly developed and applied. A detailed validation review should be carried out for a representative sample of procedures based on the validation report. It is convenient to select those procedures which have been reviewed in-depth as described in Section 4.5.4. 

Verification and validation reviews requirements shall be developed and implemented by WSRC in compliance with ANSI/ASME NQA-2 (Reference 2). Deviations from these requirements shall be documented, justified with compensatory actions, and submitted to DOE for review. 

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