1.0 OBJECTIVE: To design a Standard Operating Procedure that describes the procedure Quality Assurance Program.
2.0 RESPONSIBILITY: It is the responsibility of the Quality Assurance Officer to monitor the facilities, equipment, personnel, methods, practices, records and control in each declared study.
3.0 PROCEDURE:
3.1 The Quality Assurance Unit (QAU) maintains a Master Schedule sheet of all laboratory studies conducted at the testing facility. This master schedule, indexed by test article indicates:
3.1.1 the date study was initiated
3.1.2 nature of the study
3.1.3 test article
3.1.4 test system
3.1.5 anticipated audit dates
3.1.6 current status of each study
3.1.7 identity of the sponsor
3.1.8 name of the study director
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The signed printed paper format of the master schedule is the official version of this record and will be maintained and archived as such.
3.2 The QAU maintains separate copies of all research protocols for which it is responsible.
3.3 The QAU should inspect each non-clinical laboratory study at intervals adequate to assure the integrity of the study and memorialize its inspection. The QAU should:
3.3.1 Prior to the initiation of the study:
3.3.1.1 Inspect all equipment designated for use in the study to determine that it has been adequately inspected, calibrated and maintained.
3.3.1.2 Evaluate personnel to ensure each individual engaged in the conduct of or responsible for the supervision of a non-clinical laboratory study shall have education, training, and experience or combination thereof, to enable that individual to perform the assigned functions.
3.3.1.3 Inspect the testing facility to determine that written SOP’s are in place to ensure the quality and integrity of the data generated in the course of the study.
3.3.1.4 Determine the critical phases of the study and schedule audits at appropriate times for quality assurance.
3.3.1.5 Review and evaluate the study protocol to insure it is complete.
3.3.2 During the course of the study:
3.3.2.1 Conduct study audits at the pre-determined intervals listed on the Master Schedule.
3.3.2.2 Re–inspect equipment at intervals to ensure it remains calibrated/certified throughout the study for studies of long duration.
3.3.2.3 Review personnel to assure anyone added to the study is adequately trained to perform their duties.
3.3.2.4 Periodically submit to the study director and management written status reports of each study, noting any problems and the corrective actions taken.
3.3.2.5 Determine that no deviations from approved protocols or standard operating procedure were made without proper authorization and documentation.
3.3.3 After the conclusion of the study:
Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study.
3.3.3.1 Prepare and sign a statement to be included with the final study report, which shall specify the date inspections were made and the findings reported to management and to the study director.
3.4 Study protocols are evaluated prior to initiation of the study to assess the following components are adequately described, when applicable-
3.4.1 General statements-
3.4.1.1 Study number
3.4.1.2 Study title
3.4.1.3 Study objectives/methods
3.4.1.4 Purpose of study
3.4.1.5 Sponsor and address
3.4.1.6 Testing facility and address
3.4.1.7 Key personnel
3.4.1.8 Signature of the study director
3.4.2 Compliance statement-
3.4.2.1 GLP compliance
3.4.2.2 Facility accreditation
3.4.2.3 Quality assurance monitoring
3.4.2.4 Protocol alteration
3.4.2.5 Amendments procedure
3.4.2.6 Deviations procedures
3.4.3 Test/control articles-
3.4.3.1 Test article name
3.4.3.2 Preparation of test article
3.4.3.3 Source of test article
3.4.3.4 Purity
3.4.3.5 Stability
3.4.3.6 Name of the control article
3.4.3.7 Source of control article
3.4.3.8 Stability
3.4.4 Test system-
3.4.4.1 Source
3.4.4.2 Characteristics(species/strain, sex, body weight, age)
3.4.4.3 Justification of the test system
3.4.4.4 Number
3.4.4.5 Date of arrival
3.4.4.6 Quarantine procedures
3.4.4.7 Acclimatization intervals
3.4.4.8 Method of unique identification
3.4.4.9 Animal husbandry
3.4.4.10 Dates for clinical evaluations
3.4.4.11 Dates of necropsy
3.4.5 Proposed study dates-
3.4.5.1 Study initiation date
3.4.5.2 Receipt of animals
3.4.5.3 Dates of critical phases
3.4.5.4 Study completion dates\
3.4.6 Test/control article administration-
3.4.6.1 Delivery system
3.4.6.2 Route and method
3.4.6.3 Justification of route and method
3.4.6.4 Preparation of administration
3.4.6.5 Concentration test article in carrier
3.4.6.6 Assay of test article
3.4.6.7 Vehicle (if used)
3.4.6.8 Amount of test article required
3.4.6.9 Frequency of administration
3.4.7 Experimental design-
3.4.7.1 Group designation
3.4.7.2 Method of group selection
3.4.7.3 Group characteristics (age, sex/group)
3.4.7.4 Interim sacrifice
3.4.7.5 Terminal sacrifice
3.4.7.6 Types of measurements
3.4.7.7 Specimens to be maintained
3.4.7.8 Pathology facility, address, personnel
3.4.7.9 Archive location and period
3.4.8 Data, records, and specimens retention
4.0 PRECAUTIONS:
4.1 Quality Audits should be made from time to time.
4.2 Formats should be designed with proper codes.
4.3 Training of the technical and non-technical staff should be done from time to time.
4.4 Archive should be maintained.
4.5 Outline of each project should be prepared as per the quality norms.
4.6 Data and records should be maintained.
5.0 REFERENCES:
5.1 Study audits are conducted at intervals to assure the integrity of the study and shall consist of:
5.1.1 In- process reviews of procedures to assess the performance of the study in compliance with the study protocol, standard operating procedures.
5.1.2 Review of animal records such as arrival records, medical records, surgical records and room status sheets etc.
5.1.3 Review of protocol specific records such as laboratory test, surgical records, dosing records, data measurements records, test/ control article records, sacrifice/tissue collection records.
5.2 Final reports are evaluated by the QAU to assure that the report accurately describes the methods of the nonclinical laboratory study, standard operating procedures of the nonclinical laboratory study and reflects the raw data of the nonclinical laboratory study.
5.3 Inspections, audits, and reports are memorialized in writing by indicating the inspection number, date of the inspection, study inspected, phase or segment of the study inspected, person performing the inspection, findings and problems.
5.4 The study director reviews the concerns and deviations found by the QAU and responds in writing back to the QAU, and they are copied to management, addressing each concern and the corrective action taken within 30 days for the inspection report.
5.5 Any problems found during the course of an inspection, which are likely to affect the integrity of the study, shall be brought to the attention of the study director and management immediately.
5.6 All inspections, audits and reports records and their responses should be maintained in the QAU file entitled audit reports and archived.
5.7 All records maintained by the QAU should be in writing, and indexed in the following manner:
5.7.1 Study protocol
5.7.2 Master schedule
5.7.3 Audit reports
5.7.4 Deviations to study protocols
5.7.5 Study equipment
5.7.6 Study personnel
5.7.7 Interim study report
5.7.8 Final study report
END OF DOCUMENT
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