Documentation quality assurance review

You should consider obtaining internal and external quality assurance reviews of the study (to ferret out errors in modeling, data, etc.). Independent peer reviews of the QRA results can be helpful by presenting alternate viewpoints, and you should include outside experts (either consultants or personnel from another plant) on the QRA review panel. You should also set up a mechanism wherein disputes between QRA team members (e.g., technical arguments about safety issues) can be voiced and reconciled. All of these factors play an essential role in producing a defendable, high-quality QRA. Once the QRA is complete, you must formally document your response to the project team s final report and any recommendations it contains. 

The integrated IND team brings three important advantages. First, many sections of the IND, while defined in FDA guidance documents as self-standing descriptions, actually represent interactive results of input from different organizational subunits. The connection between CMC stability results and Quality Assurance review of the manufacturing site and procedures is a prime example. 

All regulatory documents presumably are subject to a tripartite review process. The submission is reviewed by the corporate Regulatory group, which proofs, considers issues of conformity to internal policy and to FDA guidance and checks the factual statements. A Quality Assurance review then rechecks all the previous items and independently confirms all facts and statements. Finally, a corporate review (at or near the top of the organization) precedes the final signatures and confirms conclusions and plans. 

An active program of surveillance of the quality of the immunos-tains produced must be defined. The primary elements of such a QA program include procedures and policies for patient test management, quality control, proficiency testing, comparison of test results, relationship of clinical information to patient test results, personnel assessment, communications, complaint investigations, quality assurance review with staff, and quality assurance records. The documentation and review by the laboratory director of all QA procedures are imperative and cannot be overstressed. A brief explanation of each of the QA elements is as follows ... 

I C Energo s Quality Control was defined in the I C Energo document Quality Assurance Programme prepared as part of the subcontract work. This programme deals with the whole process from the general company quality system, subcontract review to quality assurance and control during the project realisation. 

In the Cochrane Reviews database 81 protocols and reviews are available (Cochrane Reviews database). This includes continuing education and quality assurance (16 documents), financial interventions (7), organisational interventions (26), and reviews of interventions to improve specific types of practices (28). Several of the documents involve practices with elderly and medications focus. Specific focus can be found in four of the protocols... 

The management system for process definition documentation should ensure that the contents of the process documentation package are accurate and complete. A suitable review and quality assurance program should be implemented for the process documentation. This may involve a hierarchical review process, and/or using external experts in a review capacity. 

Normally only mixed explosive standards should be taken into, or used in, a trace laboratory this has the advantage that in the unlikely event of an error the presence of multiple species matching the mixed standard will clearly show what has happened. If circumstances dictate the use of a single standard, it is important to document any extra precautions taken to prevent confusion between samples and standards. It may also be wise to review the cleaning and quality assurance... 

Preparation In preparing for an audit, all data and documentation for the study are assembled for the inspectors to view (Figure 8.3). The study director, or other designated technical contact, should review the files and prepare to answer any questions. The master schedule and all files assembled by the quality assurance unit should be reviewed. An agenda, a work space, and a test facility floor plan should be prepared for the inspectors. The staff should be fully briefed and prepared for the visit. 

Each process owner is required to work closely with his or her QA counterpart. This ensures design and operational issues are clearly reviewed and approved by a representative from the quality assurance function, a regulatory expectation. The quality assurance counterpart must be familiar with the process, understand documentation supporting the process, and able to convey what approval the Quality... 

Validation Team A well-defined validation team with a well-written description of responsibilities is required and assures the adequate realization of the validation tasks. A validation team should be composed by different responsibilities responsible-of-validation team, team leader, archive manager, test coordinator, quality assurance member, tester, and witness. The responsible-for-validation team elaborates and approves the VMP, protocols, and reports. The team leader should be responsible for the computer system validation and utilization. An archive manager is responsible for the management of all computer system validation documents. The test coordinator is responsible for the computer system test and coordinates the elaboration and operation of tests for evaluating the performance of the computer system. A quality assurance member is required to periodically inspect and train the personnel and review all the validation documents. The tester is responsible for the execution of the tests required to perform the validation protocol. The witness is responsible for observing and reviewing the operations of the tester. 

According to cGXP requirements, this plan should be reviewed and approved. Quality assurance involvement is recommended. It would be possible to generate a combined plan/protocol document that includes all information described in this chapter. The actual results generated during validation have to be added to complete the protocol. 

The review and approval (system acceptance) will include information about the approvers. All validation documents have to be reviewed and approved with involvement of the quality assurance unit. Figure 18.12 is an example. 

A decision not to perform the review (e.g., evidence that code is developed under a quality system and formal reviews have already been conducted and reported) should be documented in the project validation plan, complete with the rationale. It is recognized that under its software quality assurance program the supplier may conduct similar examination of the software using only internal resource. Considering GMP implications, the pharmaceutical manufacturer would normally require that the software designer or programmer does not carry out any software review in isolation. 

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

Qualification protocols are written documents prepared before conducting the qualification, describing the features of a particular application or item and how it should be tested. Qualification protocols identify the objectives, methods, and acceptance criteria for each test function contained in the applicable specification deliverable and identifies who is responsible for conducting the tests. In addition, the protocols should also specify how the data is to be collected, reported, and analyzed to determine if the acceptance criteria were met. The protocol should be reviewed by personnel with an appropriate understanding of computer systems and the functionality of the indicated system. Following the review, qualified personnel must approve each protocol in accordance with the company quality assurance procedures. In the software engineering world, qualification protocols are equivalent to test procedures. Traditionally the scope of the qualification protocols encompasses the following ... 

The EPA prefers that the planning document be prepared in the format of the EPA QAPP. Projects, conducted with the direct involvement of the EPA require that the QAPP be reviewed and approved by an EPA QA manager. The QAPP elements, described in EPA Requirements for Quality Assurance Project Plans, QA/R-5 (EPA,... 

Shorten approval processes—The time required to secure approvals of validation documents should be kept to a minimum. One way to accomplish this is to minimize the number of review and approval signatures required. Typically no more than five or six should be necessary. All reviewers must have sufficient technical background to understand the documents they are reviewing. In every instance, the quality assurance unit must be a part of the formal approval process. 

The successful IND is most likely a result of cooperative work with an integrated team represented by Regulatory, Quality Assurance, Clinical, CMC, and others. Quality Assurance, for example, is likely to have valuable input into the design of the Investigator s Brochure Clinical can contribute important direction and focus to the literature review Regulatory may have CMC input of value and so forth. The integrated team is more likely to both produce a smoothly integrated document and assure that the content of that document represents a cohesive and systematic assurance of public safety, which is the primary FDA focus. 

Original baseline configuration documentation generated on June xx, 1997 as part of the configuration management plan was not reviewed/approved by Quality Assurance. 

A Source Code Review must be performed on application software unless there is evidence from the Supplier Audit that the source code has been, or will be, developed in a quality assured manner and subjected to review as part of its development life cycle. The decision and justification not to perform a review must be documented within the Validation Plan. 

Design Review is a formally documented and structured process of confirming that the LIMS design is both fit for purpose in terms of the requirements of the users/business and also meets regulatory expectations. This is all part of the process of building Quality Assurance into the design. 

The determination of system impact as direct or indirect, and the result of criticality assessment, should be documented. Review and approval by Quality Assurance personnel are expected. 

The review should be formally documented and the system then made subject to ongoing change control. There must be no uncontrolled creep in the original quality assurance role of the BMS. 

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