Assists sponsors, such as automation, management of personnel, the study director and Qaus comply with good laboratory practices
A system of quality management in accordance with GLP requirements of FDA regulations will require the collaboration of four groups and / or individuals. The GLP regulations specify these groups as follows:
• Study Sponsors
• Facility Management staff
• Study Directors (usually only one per student)
• QAU (Quality AssuranceUnit)
Global Responsibility
Each of these groups or individuals should be 1) part of the behavior of each non-allocated to maintain the clinical study of safety and 2) the respective responsibilities of the FDA. Since these tasks are extensive, and automate the management of GLP-strong for the life sciences industry, already struggling against the product at break-neck-to-market time intervals recommended.
Study Sponsors
Sponsors oftennot bear the burden of ultimate responsibility for all non-clinical study. Finally, is to show the sponsor, the success, if a study is fertile with weight or trauma (ie, in general), financial losses, if not successful.
It 'easy to understand why the sponsors are not committed by many clinical studies, the maximum speed and accuracy in testing procedures to ensure, especially when one considers that the GLP-related "requirements and documentationIncreased operating costs by up to 30% compared to [not]-GLP-operation. '1
Study sponsors have a responsibility for action
Under the legislation GLP, is a sponsor for records management processes is responsible (even if he or she must provide a copy of the records that are technically already in office) and the storage of materials that do not support clinical trials. These processes could (of course) with GLP-management solutions for streamlining planned, but first, twoQuestions:
• Records management and archiving of the document is useful for automating processes with a system of quality?
• Document management is a fairly simple task?
The answer to these questions are YES and absolutely no! Sponsor careful follow, he or she believes is probably the huge benefits of investing in the notes to consider management / document control solutions.
Consider this
If you consider that the demand for paperdelivered by the truckload (which a lot of paper) for the FDA and the material for all U.S. FDA application to be saved and archived for 2 years and after FDA approval for 5 years after submission of the FDA, and is easy see that the entire archive period may extend beyond 10 years and involved millions of documents. Who wants to meet this responsibility, either manually or via e-mail, computers and cabinets?
A system of quality assurance GAP, which contains recordsManagement functions and document management for more effective compliance responsibilities sponsor of the study is essential.
Facilities management staff
Facility management personnel are also responsibilities of GLP involved. These tasks are:
• The description of the study director;
• Study monitoring;
• Setting a new principal, if the current manager does not perform wellgood;
• Ensure that a QAU is available;
• Characterize examinees / articles of control;
• Ensure that sufficient qualified personnel to conduct the study.
Ownership of the quality system
The facility management staff would benefit from 1) a quality system that has the same central control document access to be able to access a sponsor and supplied 2) proof of ability to trend, the ability to form working (automatic ), data analysis, trainingSkills, etc.
Studio Director
The director of the study can be compared to the CEO of a successful company. He or she is the head of the non-clinical study, the vessel and may have more responsibility than any other person associated with non-clinical trial work. This responsibility, according to the FDA go website2 loans, will ensure a director of the study, that:
• "The protocol, including any amendments, approved and made available through 58.120 shall be followed."
• Allexperimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. "
• "unforeseen circumstances that the quality and integrity can occur pre-study clinical laboratory are listed when they occur, and corrective actions taken and documented."
• Test systems are as specified in the protocol. "
• "to follow all applicable regulations of good laboratory practice".
• "All the raw data, documentation,Protocols, samples and the final transfer to the archives during or at the end of the study. "
Quality System Requirements
For a study director, a quality system that includes a system of document control of SOPs and protocols would be appropriate, and have the ability to change control, automatic routing / approval, deviations / ability to detect non-compliance functions CAPA, etc.
Quality Assurance Unit (QAU)
QualityUnallocated insurance unit to a clinical trial, to participate (as a separate group), the primary responsibility for compliance with the GLP-insurance. QAU responsibilities are:
• Management of the Laboratory Master Schedule
• Keep copies of the study protocol
• conduct inspections of the various studies at appropriate intervals
• Ensure that audit logs, data displayed (ie the identity of the study, the date of inspection, the problems,etc.)
• Update management and study director in relation to any problems found during an inspection
• Reporting on the state of the same (regular)
• If the determinant of the deviations that are made of essential documents.
A system of quality assurance for the quality control unit
A quality system for quality assurance unit would also be of great value if the quality system provides the following information:
• Document controlfor the captain of the program of laboratory protocol documentation, progress reports, etc.
• Functions of management control for inspections
• Analysis and reporting tools for more effective presentations made easy
• deviations and noncompliance skills
• Automatic routing and collaboration for documents that are not released and worked on a variety of groups or individuals.
Conclusion
GLP-management is based on people andIn exchange, people rely on technology to streamline the routine. Many of the procedures of GLP, not only become routine, but also huge in proportion. These groups or individuals that GLP-clinical study, responsibility and accountability requirements BPL would do well to consider this technology with the supply of which the contents of this article.
1) labcompliance.com / tutorial / GLP / default.aspx? Sm = # d_a Introduction
2)accessdata.fda. gov / scripts / CDRH / cfdocs / cfcfr / CFRSearch.cfm? CFRPart = 58 & showFR = 1 & subpartNode = 21:1.0.1.1.22.2
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