CFS - GLFC / STANDARD OPERATING PROCEDURE
Study Personnel Responsibilities
SOP Number: M02004/012/002/
TITLE: Study Personnel Responsibilities
APPROVING OFFICIALS:
DD / MM / YY
Approved By:______Management___/___/___
Concurred By:______QAU Manager___/___/___
Prepared By:______/___/___
SIGNIFICANT CHANGES FROM PREVIOUS VERSION:
-this SOP has been revised to include a section for significant changes from the previous version.
-study personnel are now required to include a date whenever signing or initialing a form or document relating to a GLP study.
-study personnel are required to document periodic review of their Staff Records and GLP Training File.
1.0Introduction
1.1Purpose
To set forth the areas of responsibility of CFS-GLFC Study Personnel for GLP compliant studies.
1.2Scope
This administrative SOP is a GLFC management that shall be followed by all personnel engaged in the conduct of GLP compliant studies.
1.3Definitions
Administrative SOP – An SOP developed by the QAU or management describing routine administrative procedures (e.g., writing an SOP) for the organization and functioning of the GLP program according to OECD Principles of Good Laboratory Practice or to GLFC procedures. The QAU is responsible for the validity of this SOP and for ensuring that personnel engaged in GLP activities function in compliance with described procedures.
Amendments - Intended changes to the Study Plan after the Study Initiation Date. Amendments should be approved (signed and dated) by the Study Director and maintained with the Study Plan.
Archivist – The individual specified by test facility management who is responsible for the management of the archive(s).
Deviations – Unintended departures from SOPs or from the Study Plan after the Study Initiation Date. Deviations should be documented by study personnel, approved by the Study Director/PI and maintained with the raw data.
Document Control Official (DCO) - The person specified by management who is responsible for controlling designated documents, including SOPs.
Effective Date - The date from which the procedures given in a SOP are to be implemented.
GLP Monitoring Authority (GLPMA) – The national authority which monitors compliance to the OECD Principles of GLP.
Good Laboratory Practice (GLP) – A quality management system set forth by the Organization for Economic Cooperation and Development (OECD) to assure the quality and integrity of the processes and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
NA - Not Applicable.
Principal Investigator (PI) - An individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study.
Quality Assurance Unit (QAU) - Persons designated by management to ascertain that the study is in compliance with current OECD Principles of Good Laboratory Practice, and who are completely independent from the conduct of the study for which they are performing quality assurance functions.
Raw Data - All original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study.
Sponsor Study Monitor – A person designated by the Sponsor to be the Sponsor’s representative, acting as a contact between the Test Facility Management, the Study Director, and the Sponsor.
Standard Operating Procedures (SOPs) - Management directives describing administrative or technical routine procedures conducted in a laboratory or field operation that are not specified in detail in the study plan or test guidelines.
Study Director (SD)- The individual responsible for the overall conduct of the non-clinical health and environmental safety study.
Study Plan -A document that defines the objectives and experimental design for the conduct of the study, and includes any amendments.
Test Facility Management – The individual who has the authority and formal responsibility for the organization and functioning of the test facility according to current OECD Principles of Good Laboratory Practice.
1.4Safety
NA
1.5Materials
GLP Form No. 0015/002, Deviation Report (Appendix 1).
2.0PROCEDURES
2.1Qualifications
2.1.1All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study.
2.1.2Each individual engaged in the conduct of or responsible for the supervision of a study shall have sufficient education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
2.2Responsibilities
2.2.1Personnel are responsible for ensuring that documentation demonstrating their competence to perform assigned tasks is included in their Staff Records and GLP Training File, as set forth in the current version of SOP No. M02004/003, Staff Records and GLP Training. Periodic review of the file shall be documented as specified in that SOP.
2.2.2Study personnel shall have access to the Study Plan and appropriate SOPs applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions shall be documented as specified below and shall be communicated directly to the Study Director and/or the Principal Investigator(s), if applicable.
2.2.3Deviations from the Study Plan or from SOPs shall be documented by study personnel during the conduct of the study on GLP Form No. 0015/002, Deviation Report (Appendix 1). The Deviation Report shall include a description and explanation of the deviation, an assessment of the significance of the deviation on the quality and integrity of the study, and any corrective actions taken. The Deviation Report shall be approved by the PI, when applicable, and shall be copied to the Study Director, otherwise Deviation Reports must be approved by the Study Director. Deviation Reports must also be signed by the Sponsor Study Monitor.
2.2.4All study personnel are responsible for quality of their data, recording raw data promptly and accurately and in compliance with the Principles of Good Laboratory Practice.
2.2.5Study personnel should exercise health precautions to minimize risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.
2.2.6Study personnel are responsible for maintaining a current file of official SOPs which are applicable to their involvement in a GLP study. The Document Control Official (DCO) is responsible for announcing the availability of new or revised SOPs and for the distribution of official copies. Upon notification by the DCO that new versions of SOPs are available, personnel shall exchange old versions for the new ones. Official copies of SOPs shall only be made by the DCO.
2.2.7During the course of the study, personnel shall make all study records available to the Study Director, and/or if appropriate, the Principal Investigator(s).
2.2.8During the course of the study, study personnel shall make all study records available to the GLFC Quality Assurance Unit (QAU) and to the GLP Monitoring Authority (GLPMA), as requested, for the conduct of a Test Facility or Study Inspection/Audit.
2.3Calculations
NA
2.4Documentation and Reporting
Compliance to this SOP may include completion of GLP Form No. 0015/002, Deviation Report (Appendix 1). Additional documentation is required in the maintenance of the employee’s Staff Records and GLP Training File, as set forth in the current version of SOP No. M02004/003, Staff Records and GLP Training.
3.0DisTRIBUTION AND ARCHIVING
3.1distribution
3.1.1Official copies of this SOP shall be made by the DCO and distributed as follows:
(a)The original SOP and an exact copy shall be retained in the GLFC archive (i.e., copies 001 and 002).
(b)One copy shall be kept by the DCO in the DCO SOP manual (i.e., copy 003).
(c)One copy shall be kept by the QAU manager in the QAU manager SOP manual (i.e., copy 004).
3.1.2The DCO shall distribute additional copies of this SOP to all personnel engaged in the conduct of, or responsible for, the supervision of GLP compliant studies.
3.1.3The DCO shall announce the availability of new versions of this SOP within one week of the effective date, and shall distribute new versions by requiring that old versions be exchanged for the new ones.
3.2Archiving
3.2.1The Archivist shall maintain current and historical versions of this SOP.
3.2.2It is the responsibility of the Archivist to assure that the individual Staff Records and GLP Training Files are maintained in the archive.
3.3Destruction of Outdated SOPs
With the exception of archived historical versions, the DCO shall ensure the destruction of outdated versions of this SOP by shredding.
4.0ASSURING SOP VALIDATION AND COMPLIANCE
4.1SOP Validation
The QAU is responsible for assuring that this SOP is valid.
4.2SOP Compliance
The QAU is responsible for assuring that this SOP is followed.
5.0REVISION of the sop
5.1Responsible Individual
The QAU is responsible for assuring that this SOP is current. If necessary, the QAU manager shall initiate the revision process.
5.2Revision Schedule
5.2.1This SOP shall be revised when its provisions no longer agree with current practices or applicable regulations.
5.2.2If this SOP requires revision, it shall be revised according to current GLFC procedures and approved within 45 calendar days of initiation of the revision process.
6.0CONTINGENCIES
When personnel find circumstances that do not permit compliance with this SOP, they shall consult management or the QAU manager within 24 hours.
7.0CONFIDENTIALITY
All SOPs are considered confidential and shall be handled accordingly. They are not to be copied or made available to outside parties without proper safeguards and the approval of management. Distribution to outside parties shall be conducted by the DCO.
8.0References
SOP No. M02004/003, Staff Records and GLP Training.
9.0APPENDICES
Appendix 1: GLP Form No. 0015/002, Deviation Report.
Appendix 1
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