Study Personnel Responsibilities
1.0 Introduction
1.1 Purpose
To delineate the responsibilities of Study Personnel in conducting
GLP-compliant studies.
1.2 Scope
This administrative SOP, managed by applies to all personnel
involved in GLP-compliant studies.
1.3 Definitions
Administrative SOP: Developed by QAU or management for
routine administrative procedures under OECD Principles.
Amendments: Changes to the Study Plan after the Study
Initiation Date, approved by the Study Director.
Archivist: Individual responsible for managing archives.
Deviations: Unintended departures from SOPs or the Study
Plan, documented and approved by the Study Director/PI.
Document Control Official (DCO): A person responsible for
controlling designated documents, including SOPs.
Effective Date: The date from which the procedures in an SOP
are implemented.
GLP Monitoring Authority (GLPMA): National authority
monitoring compliance to OECD Principles of GLP.
Good Laboratory Practice (GLP): A quality management system
ensuring the quality and integrity of non-clinical health and environmental
safety studies.
NA: Not Applicable.
Principal Investigator (PI): An individual acting on behalf of
the Study Director, with defined responsibilities in multi-site studies.
Quality Assurance Unit (QAU): Independent persons ensuring
compliance with current OECD Principles of GLP.
Raw Data: Original test facility records or verified copies,
the result of original observations in a study.
Sponsor Study Monitor: Representative designated by the
Sponsor to liaise between Test Facility Management, the Study Director, and the Sponsor.
Standard Operating Procedures (SOPs): Management directives
describing routine procedures in a laboratory or field operation.
Study Director (SD): The individual responsible for the overall
conduct of non-clinical health and environmental safety studies.
Study Plan: Document defining objectives and experimental
design for the study, including amendments.
Test Facility Management: Individuals with authority and
formal responsibility for the organization and functioning of the test
facility.
1.4 Safety
NA
1.5 Materials
GLP Form No. 0015/002, Deviation Report (Appendix 1).
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2.0 Procedures
2.1 Qualifications
2.1.1: All personnel involved in the study must be
knowledgeable in relevant parts of the Principles of Good Laboratory Practice.
2.1.2: Individuals engaged in or supervising a study must
have sufficient education, training, and experience.
2.2 Responsibilities
2.2.1: Personnel must ensure documentation of their
competence in Staff Records and GLP Training File.
2.2.2: Study personnel should have access to the Study Plan
and relevant SOPs, complying with instructions. Deviations must be documented
and communicated to the Study Director and/or Principal Investigator(s).
2.2.3: Deviations shall be documented using GLP Form No.
0015/002, approved by the PI or Study Director, and signed by the Sponsor Study
Monitor.
2.2.4: All study personnel are responsible for the quality
of their data and must record raw data promptly and accurately.
2.2.5: Study personnel must exercise health precautions and
communicate relevant health conditions affecting the study.
2.2.6: Study personnel should maintain a current file of
official SOPs applicable to their involvement.
2.2.7: Study records must be made available to the Study
Director and/or Principal Investigator(s) during the study.
2.2.8: Study records must be made available to QAU and GLP
Monitoring Authority as required.
2.3 Calculations
NA
2.4 Documentation and Reporting
Compliance may include completing GLP Form No. 0015/002.
Additional documentation is required for Staff Records and GLP Training File.
3.0 Distribution and Archiving
3.1 Distribution
3.1.1: Official copies distributed and archived as
specified.
3.1.2: DCO shall distribute additional copies to personnel
engaged in GLP-compliant studies.
3.1.3: DCO shall announce new versions and distribute them accordingly.
3.2 Archiving
3.2.1: The Archivist shall maintain current and historical
versions of this SOP.
3.2.2: The archivist is responsible for maintaining individual
Staff Records and GLP Training Files.
3.3 Destruction of Outdated SOPs
DCO shall ensure the destruction of outdated versions,
excluding archived historical versions, by shredding.
4.0 Assuring SOP Validation and Compliance
4.1 SOP Validation
QAU is responsible for ensuring SOP validity.
4.2 SOP Compliance
QAU is responsible for ensuring SOP compliance.
5.0 Revision of the SOP
5.1 Responsible Individual
QAU is responsible for ensuring SOP currency, and initiating the
revision process if necessary.
5.2 Revision Schedule
5.2.1: SOP shall be revised if provisions no longer align
with current practices or regulations.
5.2.2: SOP revisions must adhere to GLP procedures and be
approved within 45 calendar days of initiation.
6.0 Contingencies
Personnel encountering circumstances preventing SOP
compliance should consult management or the QAU manager within 24 hours.
7.0 Confidentiality
All SOPs are confidential and shall not be copied or made
available to outside parties without proper safeguards and management approval.
Distribution to outside parties is managed by the DCO.
8.0 References
SOP No. M02004/003, Staff Records and GLP Training.
9.0 Appendices
Appendix 1: GLP Form No. 0015/002, Deviation Report.
END OF THE DOCUMENT
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