Report documents quality assurance

The Study Director is the pivotal person in any GLP study. The sponsor initiates the study and assigns a Study Director to act as the primary control point for all aspects of the study. The Processing Principle Investigator (PPI) acts as an agent of the Study Director and handles the processing phase of the study. The PPI reports directly to the Study Director, and quality assurance (QA) documents resulting from the processing phase are sent to the Study Director for approval. The Study Director has final say in all questions of compliance with GLP and interpretations of the protocol. The... 

Quality Assurance personnel is required by the GLP Principles to promptly report any inspection results in writing to management and to the Study Director,. .. . Since it is also required that records of such inspections should be retained , the work of the Quality Assurance personnel exhibits in many aspects the resemblance of a study There is a plan (exacted by the master schedule), there are raw data (the inspection results, e.g. the filled-in check- lists, see as an example figure 14), and there will be a final report on the findings which has to be submitted to the relevant authorities, in this case the Study Director and the responsible management. However, since the Quality Assurance reports serve an important function, the attention of the addressees of these reports should not be blunted through continuous inundation by reports full of irrelevant details. Therefore, in the case of the Quality Assurance inspection report, this document should describe only the deficien-... 

Organization and reporting structure for inspection personnel Documenting and maintaining inspection and quality assurance procedures Documenting and reporting inspection and test results Corrective action for inspection and test results... 

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. 

All surveyors need a database of technical information, which should include reports of accidents or of defects that could lead to accidents derived from other sources. He also needs a regular supply of technical documentation from his head office that keeps him abreast of technical developments. If his company operates an effective quality assurance system, they will periodically check that he is keeping these data properly and they may control the indexing of them. 

All formulas are to be written out by hand with the specific numbers in the right places on a sheet provided for the purpose, and the calculations are to be done by calculator. Caution Write the numbers exactly as printed, do not round any digits, or the quality assurance unit (a sort of corporate vice squad) will not approve the report out of fear that someone could have cheated. A validated program can be used. While an Excel spreadsheet as such needs no validation, a simple cell-formula calls for extensive tests and documentation and proof that the sheet is password protected against fraudulent manipulation. On top of that, the analyst s supervisor is required to confirm the calculation and sign off on... 

The revised database holds over 23 000 analyte values for 660 measurands and 1670 reference materials produced by 56 different producers, from 22 countries. The database is restricted to natural matrix materials (i.e. made from naturally occurring materials, excluding calibration standards manufactured from pure chemicals). Information has been extracted from the relevant certificates of analysis, information sheets, and other reports provided by the reference material producers. As a general rule, the authors have only included in the compilation reference materials for which a certificate of analysis or similar documentation is on file. Information included in the survey is on values for measurands determined in reference materials, producers, suppliers, the cost of the materials, the unit size supplied, and the recommended minimum weight of material for analysis, if available. The new searchable database has been designed to help analysts to select reference materials for quality assurance purposes that match as closely as possible, with respect to matrix type and concentrations of the measurands of interest and their samples to be analyzed see Table 8.3. 

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

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. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

Although a thorough validation cannot rule out all potential problems, the process of method development and validation would address the most common ones. Examples of typical problems that can be minimized or avoided include interferences that coelute with the analyte in liquid chromatography (LC), a particular type of column that no longer produces the separation needed because the supplier of the column has changed the manufacturing process, an assay method that is unable to achieve the same detection limit after a few weeks, or a quality assurance audit of a validation report that finds no documentation on how the validation was performed. 

The PQ is the phase in which either a technical system is tested over a long period of time (e.g., water system), or a complex technical system is tested overall (connected filling line). For many systems OQ is the last phase performed during qualification. If there are only a few performance tests needed, it might be more practical to include them during OQ or process validation. Combining OQ and PQ decreases the number of documents (less documentation work in the future) and cuts approval time and effort. Again, the procedure for PQ is the same as for IQ and OQ ([develop PQ protocols, approve PQ protocols (by the quality assurance, production, and technical departments), perform PQ, work out the PQ report, and approve the PQ report (by the quality assurance, production, and technical departments)]. The documentation and test description are identical to those in the OQ phase. 

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. 

At the completion of the documentation, a final report should be drafted to indicate the conclusion and acceptability of the installation. The final report must be approved by the departments that approved the protocol. These are likely to be engineering/technology, production quality assurance/quality control and operations, and the validation manager. Approval of the final report by the relevant departments makes the way clear for proceeding with operational testing. 

Quality assurance—organizational independence, staff qualifications, self-inspection program, AQL, change control procedures, documentation and reports, complaint files, awareness of current regulations, statistical concept employed, batch record turnaround time, etc. 

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. 

When a protocol is issued, the study is put on the Master Schedule. The Master Schedule is a computer-generated document that can be formatted and sorted to accommodate the needs of various participants in the study as well as the Quality Assurance Section. It contains the protocol number, the trial numbers, the study title, the proposed start and finish dates of field and analytical segments of the study, the proposed reporting date, the names of field participants, the name of the study director, and other information that may be useful to the users of the master schedule. As a study... 

The approved summary report and associated validation documentation are submitted for retention to the National Quality Assurance Document Control Center or site documentation retention center... 

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 ... 

For each nonclinical laboratory study, testing facility management shall...(c) assure that there is a quality assurance unit. (e) ensure that personnel, resources, equipment, materials, and methodologies are available as scheduled, (f) assure that personnel clearly understand the functions they are to perform, (g) assure that any deviations from these regulations reported by the quality assurance unit are communicated.. . and corrective actions are taken and documented. 

Data screening and quality assurance checking were conducted at initial information retrieval and all data entries cross-checked during subsequent data compilation. Production/activity levels were verified against different information sources including annual records, selfmonitoring reports and ad hoc study reports. There was inadequate documentation of local industrial/commercial/urban activities and/or limited analytical data on the level of POPs contamination in some classes of emission sources. These were identified as inventory data gaps for followup actions. 

---