Good laboratory practice regulations

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At many institutions such services are outsourced to private enterprises whose policies and reporting structures may not interface with those of the University. This in turn can precipitate serious safety issues. Budget Operations University and Grant Expenditures.

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While this component of the modified GLP shown in Table 2 is not addressed in industrial models, it needs to be included in academic models since laboratory equipment and reagents may fall into different budget designations. Before developing SOP and SSOP, decision trees can help identify governance and responsibilities pertaining to common use items and those belonging to individual labs. In the case of the latter, the principal investigator PI could exercise his or her discretion for shared use of grant-acquired equipment.

Such monies can be used to purchase equipment. It is the responsibility of the University to establish policies regarding shared equipment acquired through grant awards or use of indirect costs to build infrastructure. There is a tendency for universities to appropriate equipment from grant-funded laboratories and to place such equipment into common use. If equipment is acquired through grant funding, the PI may have the final word in how such equipment is used by faculty, staff, and students regardless of the wishes of administrators.

Under some circumstances e. To support GLP budgets, as shown in Table 2 , purchase orders, routing, receiving, and use and disposal of equipment and reagents all require clarification. This is particularly important if equipment and reagents are shared by multiple users. Policies that safeguard end-user access help thwart collegial friction. For example, if two cases of pipettes are ordered and designated for a specific class or research activity, under a sound academic GLP plan a non-designated end user could not appropriate these items for a different class or activity. Similarly, SOPs that apply to use of equipment, shared or not, provide instructions regarding who can use the equipment, how the equipment is used, usage logs, and equipment failures.

When usage logs are properly employed, shared access is orderly and culpability for breakage and misuse is clear. It is essential that members of the department, including students, understand how equipment and reagents are used SOP , in addition to safety checkpoints, equipment failure reporting, accident reporting, sanitary standard operating procedure SSOP , and other related laboratory activities. An example of an SOP can be found in Appendix 1. The SOP template adopted by an institution organizes information in a consistent and reproducible manner.

Most sections are short with the exception of the Procedure, which is often written in cookbook fashion. A footer denotes the version and author and may include approval routing. Technical and safety information, company contacts, references, and supporting documents can be attached in appendices. Each section is precise. The safety of operations and longevity of equipment is linked to this understanding. Proper training of students reflects academic excellence and sets the stage for retention, increased enrollment, improved academic performance, and a competitive advantage for graduating students in the professional workplace.

Reporting of Results, and 6. These components of GLP do more than validate the model. In academic institutions, good record keeping is reflective of efficient and sound educational practice.

Good laboratory practice regulations

Accreditation, grant acquisition, and placement of students in post-graduation career paths all parallel the guidelines established for GLP. It is incumbent upon each department to scaffold how and where reporting logs are kept and archived. These records allow new faculty and staff to modify and maintain GLP as the University evolves. Handbooks and manuals can also include routing and reporting structures. When necessary, these documents should be translated into multiple languages as needed at individual institutions.

In the long run, application of these practices vastly improves laboratory efficiency and safety. Understanding that accepted policies apply to everyone in the hierarchy removes the basis for incorrect assumptions. Most importantly, modeling GLP for students provides pre-professional training and fosters collegial respect. National Center for Biotechnology Information , U. J Microbiol Biol Educ. Published online Apr Susan M. Author information Article notes Copyright and License information Disclaimer.

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Corresponding author. Mailing address: Marian University, 45 S. National Ave. Phone: Fax: E-mail: ude. Received Aug 10; Accepted Dec Published by the American Society for Microbiology. This article has been cited by other articles in PMC. Quality Assurance QA Quality Control QC Educational Applications Definition A set of activities for ensuring quality in the processes during which products are developed A set of activities for ensuring quality in products ready for market.

The activities focus on identifying defects in the actual products produced. QA processes are the formative educational practices that address lab skill sets and course objectives. Conversely, QC would reflect summative review of benchmark achievement for learner outcomes.

Focus Proactive: Aims to prevent defects with a focus on the process used to make a product. Reactive QC activities address correcting failures to adhere to protocols and policies or to improving practices as part of the evolution of education. Goal To improve development and test processes so that defects do not arise when the product is being developed. During formative assessment of learner outcomes, educators can identify what skill sets require improvement.

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Departmental review of GLP supports revision of procedures and policies during summative assessment. Developing Plans Establish a good quality management system and the assessment of its adequacy. Periodic conformance audits of the operations of the system. Find and eliminate sources of quality problems through tools and equipment so that [customer] requirements are continually met. Many universities offer shared access to handbooks, policies, and procedures on internal networks. QA as applied to GLP seeks to advise and train everyone involved in teaching lab activities; QC identifies gaps in information distribution and application conformity and guides modification and corrective actions.

Methods Prevent quality-related problems through planned and systematic activities, including documentation. Apply activities or techniques to achieve and maintain the product quality, process, and service. QC follows through the verification procedures that document how GLP is practiced and reviewed. Responsibility Everyone on the team involved in developing the product is responsible.

What is Good Laboratory Practice (GLP)?

Usually the responsibility of a specific team that tests the product for defects. Open in a separate window. Organization and Personnel Student Faculty Support Staff Chairperson Dean Administration Delineation and segregation of duties and responsibilities, handbooks, policies, SOP, and other guidelines In the course of Instruction Reporting Monitoring Audits Reviews Oversight structures are clear and guidelines transparent and easily accessible Throughout the infrastructure, classroom, laboratories, and online 2.

Facilities Trained staff and end users instructors, students, lab personnel Sanitation Maintenance Calibration Repair and Replacement Needs Assessment On a regularly scheduled basis According to best GLP; FDA, and other regulatory agencies; and the University On-site, with records of actions taken archived in a secure location in hard copy or electronically 3. Archival All oversight reporting authorities including staff, supervisors, faculty, administrators and technicians Reports, Copies of SOP, Certifications, Validations, Corrections, and related documents are stored hardcopy or electronically.

Weekly, monthly, yearly as needed In hardcopy or electronically with file identifiers as used in SOP As in 5. Schneider K. Ruark J. Texas regents fire tenured professor at San Antonio campus for creating safety hazard. Chron Higher Educ. University of California. Irvine independent accident investigation: Injury and fire resulting from benzene vapor explosion in a chemistry laboratory, Frederick Reines Hall, University of California, Irvine.

Good laboratory practice compliance | European Medicines Agency

July 21, Final Report. Robinson K. GLPs and the importance of standard operating procedures.