Validation report

Pharmaceutical sites will usually create a dedicated team of validation specialists to coordinate all validation activities. They should operate according to a validation master plan that has been developed using risk analysis to identify the most critical systems requiring validation/re-validation. Before validating a system or process, a written protocol should be prepared that describes the system, the critical aspects, the objectives, the test methods and the acceptance criteria that will be applied. A validation report should be prepared on completion of each protocol. 

The pair set out to write up the first section of the validation report but their triumph was short-lived. A dispassionate colleague pointed out one fallacy and two GMP violations ... 

To demonstrate the validity of an analytical method, data regarding working range/ calibration, recovery, repeatability, specificity and LOQ have to be provided for each relevant sample matrix. Most often these data have to be collected from several studies, e.g., from several validation reports of the developer of the method, the independent laboratory validation or the confirmatory method trials. If the intended use of a pesticide is not restricted to one matrix type and if residues are transferred via feedstuffs to animals and finally to foodstuffs of animal origin, up to 30 sets of the quality parameters described above are necessary for each analyte of the residue definition. Table 2 can be used as a checklist to monitor the completeness of required data. 

B. Richter, J. EzzeU, and D. Felix, Single Laboratory Method Validation Report Extraction of Organo-phosphorus Agrochemicals, Chlorinated Herbicides and Polychlorinated Biphenyls Using Accelerated Solvent Extraction (ASE) with Analytical Validation by GC/NPD and GC/ECD, Document 101124, Dionex Sunnyvale, CA (1994). 

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

QA SQPs should specify the amount of data to be audited and how the data points are chosen for audit. An auditor may choose to perform more thorough and more frequent audits on a recently validated system. The validation report can be used to assist in determining what and how much to audit. For example, if data summary printouts from the chromatographic computer system are used in the report, the validation report should be reviewed to verify that this summary function was tested during validation. If this portion of the computer software was successfully validated, verifying a few values from each table in the report may be sufficient. 

The facility inspection should include a review of the computer systems and software to ensure they have been validated. There may be differences between how network systems are validated in contrast to stand-alone systems. The records, procedures, and SOPs for the different systems should be reviewed as part of the facility inspection. If validation reports have not previously been reviewed by the QA unit, the facility inspection may provide an opportunity to review these reports and data. 

C. Kotts, E. Gilkerson, D. Trinh, G. Hawker, A. Chen, H. Gazzano-Santoro, Assay validation report Cell proliferation test for human growth hormone, Pharmacopeial Forum, 25(3), 8313 (1999). 

The method(s), supporting validation reports, related knowledge and target specifications are critical inputs into risk assessment process. A review is performed jointly by a transfer team from both sites. There is an assessment of complexity (simple vs. complex) and prior knowledge (similar methods/API/products already transferred vs. no experience), method robustness (low vs. high concern), which can affect quality post transfer (low vs. high risk). 

Knowledge based only Method, method validation report related knowledge and target specifications None None Updated training record... 

A number of empirical relationships have been published which could be used to predict partition coefficients from solubility data [19-29, 65, 72, 78-97]. Comparisons among these relationships may be confusing since different sets of compounds and different solubility terms are used. A theoretical analysis of partition coefficient with reference to aqueous solubility is important because it illustrates the thermodynamic principles underlying the partitioning process. The objective of that relationship is its utility for both predicting and validating reported values for partition coefficients. 

Chapter 6 describes the desired improvement of method parameters from the robustness point of view, not from the analyte or the specific analysis point of view. Illustrative examples are provided to help the reader develop methods with the currently available equipment. It is important that the method be described explicitly and unequivocally and that the validation report does not raise expectations that cannot be met in daily use. 

In addition to these newly proposed test guidehnes, suggestions are being considered for new parameters to be included in the present repeated dose oral toxicity test (OECD TG 407) with more emphasis to be placed on detection of endocrine effects. The vahdation of the enhanced OECD TG 407 is now being reviewed by an international panel of reviewers. The peer review package, submitted to the panel and available at the OECD Web site for endocrine dismpters (OECD 2007b), includes the validation report, the draft and the current test guidelines, and a Secretariat document to support the peer review panel. 

Could regulators conduct their own audits, not depending upon validation by laboratories In theory that strategy could be successful, but two problems stand in the way. First, resources, including time and expertise, permit only a very cursory spot check on compliance. Those limited resources are much better spent in reviewing comprehensive validation reports than in conducting very limited tests of system performance and compliance. 

Reviewing and approving validation reports. The validation process is a program that provides a high degree of assurance that a process will consistently produce a result meeting predetermined acceptance criteria. 

Therefore, an economic analysis must measure the quality of life of the patient to ensure that the value of the drug incorporates the patient s perspective. Quality of life is a concept that usually incorporates the physical, mental and social well-being of the patient. Initial doubts concerning the ability of schizophrenic patients to provide reliable and valid reports of their own quality of life led to the use of proxies for patient interviews. Caregivers and clinicians were consulted most often. However, recent research has shown that the use of proxies can produce very different results to those derived directly from the patient s responses. In addition, research now indicates that schizophrenic patients are able to provide stable, reliable and valid self-reports of their psychological well-being, health status and subjective evaluation of drug therapies (Awad et al., 1995). 

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. 

Once the validation report is completed and approved, a qualification run should be made with the system to verify that validations will be duplicated in normal operation. 

ABC Pharmaceutical Industries information. A copy of the filter retention validation report for (product name) USP is included in (reference... 

Sterilization validation reports are provided in validated archives. 

Dry heat sterilization validation. The tunnel operations conform to the master validation plan employed at ABC Pharmaceutical Industries. The sterilizing tunnel has undergone installation qualification, operational qualification, and performance qualification. The sterilizing tunnel is revalidated on an annual basis. The sterilization/depyrogenation cycle revalidation data for the tunnel are provided in validation archives. Sterilization validation reports are provided in validation archives. 

A concurrent intensive monitoring of air, surface, and personnel hygiene should be performed during all validation procedures within the aseptic area. For documentation use Attachment No. 1700.100(A). For template validation/ report refer to Attachment No. 1700.100(B). 

MICROBIOLOGY VALIDATION REPORT STERILITY TEST OF (PRODUCT NAME) COMPLEMENTARY TEST... 

---