Validation Reviews reporting

In those countries where reports are evaluated and recorded, specialized bodies have been set up to review ADR reports. Each country has a different set of operating procedures for this body. In Australia, Malaysia and Zimbabwe, a specialized committee is employed as part of the DRA to carry out the review task. The Adverse Dmg Reactions Advisory Committee in Australia, for example, has a system for following up and validating the reports, classifying the reported incidents as possible , probable or certain and then referring them to the appropriate patties for further action. 

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. 

Following a successful periodic review, acceptance of the evaluation should be clearly stated in the periodic review report and approved by the system owner and signed by designated members of the validation team. 

The periodic review report(s) should be retained in the validation file as a record of the computer system validation of the validation status and the validation plan should be updated with a date for the next 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... 

The concept of a Validation Summary Report can be taken a step further in the form of a Validation Certificate. This merely states that a computer system is validated, and it specifies a review date against this validated status. While a Validation Certificate could be presented to a regulatory inspector as evidence of validation, this would probably just prompt the inspector to request more detailed information. The effort to produce and maintain Validation Certificates must be carefully weighed. 

Inventory of systems System/project overviews Validation plans/reports and reviews Presentation slides Internal briefing papers Document map Trained persoimel... 

To complete the project life cycle, the Project Team should produce a Validation Report that aligns with the site Validation Plan. In addition to conhrming site validation activities, Validation Reports should conhrm the adequacy of all relevant central activities. A central Validation Snmmary Report (Quality Report) should be developed reviewing the adeqnacy and release of each appUcation/prod-... 

When the project comes to the end, and all Validation Reports have been completed, each report must be reviewed to ensure nothing is ontstanding and that all parts of the project are satisfactory for use. This information is covered by the Validation Snmmary Report, which shonld be the last validation document of the validation suite to be written. 

The approach to DQ may be in the form of a DQ Protocol which is formally completed to record the assessment of the various design activities, or as a process which will produce a set of review reports that are then collated as a record. Which of these two approaches is taken is not important what is essential is that a formally documented approach is followed. A DQ Protocol has been successfully used many times by the author and provides a condensed formal record to support the qualification process, but it does not remove the need for producing reports for software code reviews (SCRs), GLP assessments and so on. It is important to note that the VMP or Validation Plan must clearly document the method to be used and, therefore, the documentation to be produced to support validation. 

Following the completion of the Source Code Review, a review report or a number of review reports will be produced to summarize the review findings. These reports may identify actions to be taken by the LIMS supplier, the analytical manufacturer, or the personnel responsible for performing the validation of the LIMS. These actions may range from identifying specific testing that will need to be included in the testing process to revisions of the source code due to deviations from GPP or to correct errors. 

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. 

Despite the above discussions, the study is bounded with the involved uncertainties. Use of specific databases as AIB and ForeSea to extract the reports may introduce some level of uncertainty that roots to the way that the databases are formulated. Thus, the study needs to be repeated using reports prepared by other authorities and data providers. The main uncertainty in the result, however, comes from the small used datasets as only 22 accident reports are reviewed. In that respect, increasing the number of reviewed reports can increase the validity of such studies. 

Such approximation is valid when the thickness of the polymeric layer is small compared to die thickness of die crystal, and the measured frequency change is small with respect to the resonant frequency of the unloaded crystal. Mass changes up to 0.05% of die crystal mass commonly meet this approximation. In die absence of molecular specificity, EQCM cannot be used for molecular-level characterization of surfaces. Electrochemical quartz crystal microbalance devices also hold promise for the task of affinity-based chemical sensing, as they allow simultaneous measurements of both tile mass and die current. The principles and capabilities of EQCM have been reviewed (67,68). The combination of EQCM widi scanning electrochemical microscopy has also been reported recently for studying die dissolution and etching of various thin films (69). The recent development of a multichannel quartz crystal microbalance (70), based on arrays of resonators, should further enhance die scope and power of EQCM. 

The applicant must submit complete copies of dossier to the EMEA, and directly to each of the rapporteurs. The EMEA are allowed 14 days to validate the application to ensure that it is complete and in accordance with the regulations, after which the rapporteurs can commence the scientific evaluation. The review process involves considerable feedback between the rapporteurs, the CHMP and the applicant, central to which can be achieving agreement on the final text of the SPC, labels and leaflet. The rapporteurs are required to deliver preliminary assessment reports to the CHMP within 80 days of the start of the review process. The applicant is also copied on the report. Over the next 40 days issues raised in... 

The decentralised procedure can be used in cases where the product has never been authorised in any of the Member States, and the applicant wishes to obtain a license in a number of states simultaneously. The applicant must submit applications with the complete dossier to the Competent Authorities of each of the Member States where authorisation is desired. A single Member State should be chosen as the reference state to undertake the scientific assessment ofthe complete dossier, while the other states are designated as concerned states. The review process has many parallels vhth the centralised procedure, in that similar time lines exist, the reference State plays the role ofthe rapporteur, and the concerned States replace the CHMP. Once all States have validated that the dossiers are complete, the reference State is allowed 70 days to review the dossier and prepare a preliminary assessment report, which is circulated to the concerned Member States and the applicant. Comments from the concerned Member States and applicant responses are collected so that by day 120 the reference State may issue a draft assessment report together vhth draft SPC, label and leaflet texts. The clock may be stopped until requested responses from the applicant are received. The application then enters the second step in the assessment process, during which all the concerned Member States consider the... 

The review of MRL applications is similar to that for centralised marketing authorisations conducted by the EMEA, in that rapporteurs are responsible for the hands-on evaluation, which is then reported back to the CVMP for consideration. If there are outstanding issues, a list of questions is forwarded to the applicant for his or her response. Otherwise, a formal opinion is prepared and presented to the Commission for legal implementation as a decision. The maximum time allowed to deliver a CVM P opinion is 120 days, excluding the time taken for an initial validation of the application and review of responses form the applicant where necessary. 

This system assures overall compliance with cGMPs and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (e.g. change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). It includes all product defect evaluations and evaluation of returned and salvaged drug products. 

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