Validation Reports overview

On satisfactory completion of the computer system qualifications, with PQ conducted in conjunction with a successful process validation, a final report must be prepared by the pharmaceutical manufacturer s validation team. This is normally referred to as the validation report. The objective of the report is to give an overview of the results of the execution of the validation program for the computerized operation and to draw a conclusion as to the suitability of the computerized operation for pharmaceutical manufacturing. This may be unconditional use or there may be restrictions. In the latter case the proposed remedial ac-tion(s) must be approved and, as applicable, considered under change control. A schedule to complete any outstanding actions must be documented and progress formally reported. 

The Validation Report must include an overview of all documentation, including appendices. 

It should be possible for a regulator to get a complete picture of the validation exercise from the Validation Plan, Validation Report and overview documents. The Validation Report should be reviewed to ensure that any changes not already documented during the project are detailed so as to give a consistent picture from planning to reporting. 

In Table 1, the typical validation parameters required for the different types of analytical procedures are listed. For all these analytical procedures CE might be an appropriate analytical technique. In fact numerous validated CE methods for pharmaceutical analysis have been described in literature during the last decade.In Table 2, an overview is listed of the ICH validation parameters included in several reported CE validation studies. Since chiral purity determination is an important application area of CE methods, this test is listed separately as a specific analytical procedure. In addition, the determination of drug counterions has been included as a separate application. This overview illustrates that in general the required validation parameters are addressed in reported CE validation studies. It should be noted, however, that the validation parameters included in Table 2 are not necessarily evaluated exactly according ICH requirements in the reported references. Many pharmaceutical companies apply a phase-related validation approach in which the depth of validation depends on the clinical phase of development of the product involved. 

Figure 6.5 shows the structures of tra 5-cinnamic acid and four cinnamic acid derivatives (phenolic compounds) reported to be present in potatoes. Because potatoes are one of our major food plants, we validated with the aid of HPLC and LC/MS the content and distribution of antioxidative phenolic compounds in parts of the potato plant, in potato tubers, in the peel and flesh of tubers, in potatoes sold commercially in Korea and the United States, and in home-processed potatoes. The following discussion, based on our own studies, is followed by a brief overview of analytical methods for potato phenolic compounds by other investigators. 

A VMP should be divided into chapters covering different subjects. First, an introduction should state the manufacture s validation policy, general description of the scope of those validation activities covered by the VMP, and their objectives, derivation, location, and schedule. Then, it must declare all validation activities and their organizational structure in terms of personnel responsibility for the VMP, validation protocols, validation work, report and document preparation projects, approval of the same validation protocols, reports in all stages of validation processes, and the training needs in support of validation. Other requirements of the VMP are cross references to other documents and to specific characteristics of the processes that are critical for yielding a quality product. Next, all validation activities comprised in the VMP should be summarized and compiled in a matrix format. Such a matrix should provide an overview and contain all items covered by the VMP that... 

The overall project itself requires formally structured planning and control in addition to the validation plans for the computerized operation. To provide this, a project and quality plan from the pharmaceutical manufacturer (or its nominated main contractor) is normally developed as a separate and complimentary document and needs to overview all activities, resources, standards, and procedures required for the project. The plan should define project-execution procedures, quality management procedures, engineering standards, project program, and project organization (with authorities and reporting responsibilities), and reference the project validation plan. There are instances in which the project and quality plan and the project validation plan can be combined into one document. 

Tietge, J.E., Mount, D.R. and Gulley, D.D. (1994) The Gas Research Institute freshwater salinity toxicity relationship model and computer program overview, validation and application, Topical Report, Gas Research Institute, Chicago, IL, USA. 

Standards that are derived using SSDs for the soil ecosystem can in some cases be validated in the held. The overview by Posthuma et al. (2002) reported on some validation studies in which it was shown that the HC5 was lower than the no-effect concentration of studied ecosystems (i.e., in mesocosm or held conditions). An array of further studies has been published since that time. However, held studies are often difhcult to interpret in terms of dose-response relationships. This difficulty in interpreting held data is sometimes due to soil heterogeneity and a highly variable soil ecosystem. Nevertheless, held soils are relevant test systems and represent a more realistic environment. Although causality may be difhcult to assess, the use of pragmatic methods, derived from an expert judgment process, can improve the overall accuracy of standards. 

System requirements and overviews Development methodology Validation Plans and Reports Testing records... 

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

A scientific method is a systematic approach used in scientific study, whether it is chemistry, biology, physics, or other sciences. It is an organized process used by scientists to do research, and it provides a method for scientists to verify the work of others. An overview of the typical steps of a scientific method is shown in Figure 1-9. The steps are not used as a checklist to be done in the same order each time. Therefore, all scientists must describe their methods when they publish their results. If other scientists cannot confirm the results after repeating the method, then doubt arises over the validity of the reported results. 

The initial broad effort established basic foundations and served for further expansion while the principal tenets have remained valid to date. When reported in the open literature, the new large pore materials immediately attracted attention of the scientific community, especially in catalysis and adsorption fields. Subsequent effort by many groups led to unforeseen expansion not only in terms of the overall effort and abundance of materials and phenomena but also new directions pursued. There is probably close to 10,000 publications on the subject [1], This presentation will focus primarily on fundamental concepts and ideas related to synthesis. For detailed and comprehensive treatments one is referred to the review publications that have been appearing regularly [13-20], For up-to-date overview of state of the art several recent reviews are especially recommended [17-20]. 

With the majority of ERP projects in the pharmaceutical industry, only relatively small changes in project direction are necessary to produce the required evidence for a validated system. The production of specifications, test plans and overview documents are all activities that appear on the standard ERP project plan. In many cases, the issue appears to be in organizing the documentation to ensure specifications are categorized into the V model categories, overview documents and summary reports are written, test evidence is collated and comprehensive Source Code Reviews are retained. 

Harrison, L. (1997) The validity of self-reported drug use in survey research an overview and critique of research methods. NIDA Res. Monogr. 167,17-36. 

The formation of constant property drops has been studied extensively and is reported in many textbooks and journal papers. Several text books are available on the subject Eggers has been a leading researcher in jets and drops over the past decade and has published a number of papers The reader is encouraged to review fliese resources for a more in-depth look at jets, drops, and sprays of common fluids extending to breakup. A brief overview of one method of predicting the maximum diameter of a static pendant drop is presented here for context and to compare with experimental results obtained with common fluids that are used to validate the experimental procedures and the numerical simulations, thereby providing a foundation lor the extension of the concepts to non-isothermal fluids with varying properties. 

The chemical and ionic-size similarity governs also here. For the YBa2(Cui 2Mz)306+ -type substitution, an overview of candidates for substituents is presented in table 29, together with the phases involved in the equilibrium at the solid-solution limits. Despite the comprehensive literature on these substitution phases, such key data are not frequently reported, simply because the extra labour has not been undertaken to perform the tedious experimental work on poly-phase materials to ensure equilibrium. This statement is particularly valid for the investigations on substituents with very low limits of solid solubility (Andresen et al. 1991), where also the detection threshold for the adopted analytical method should be taken into consideration. With the high sensitivity PXD instrumentation used by Andresen et al. (1991), the detection limit is some 0.5 and 1 wt%... 

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