Good Laboratory Practices

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Good Laboratory Practices (GLP)

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Good Laboratory Practices In the 1970s, FDA inspections of nonclinical laboratories revealed that some studies submitted in support of the safety of regulated products had not been conducted in accord with acceptable practice, and that accordingly data from such studies was not always of the quality and integrity to assure product safety. As a result of these findings, FDA promulgated the Good Laboratory Practice (GLP) Regulations, 21 CFR part 58, on December 22, 1978 (43 FR 59986). The regulations became effective June 1979. Assure the quality and integrity of safety Nonclinical laboratory studies

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FDA has implemented this program of regular inspections and data audits to monitor laboratory compliance with the GLP requirements. The objective of this program is to verify the quality and integrity of data submitted in a research or marketing application, to inspect (approximately every 2 years) nonclinical laboratories conducting safety studies that are intended to support applications for research or marketing of regulated products, to audit safety studies and determine the degree of compliance with GLP regulations

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Types of Inspections 1. Surveillance Inspections . These inspections include a facility inspection and audits of on-going and/or recently completed studies. 2. Directed Inspections. Verifying the reliability, integrity, and compliance of critical safety studies being reviewed in support of pending applications. Investigating issues involving potentially unreliable safety data and/or violative conditions brought to FDA’s attention. Reinspecting laboratories previously classified OAI (usually within 6 months after the firm responds to a Warning Letter). Verifying the results from third party audits or sponsor audits submitted to FDA for consideration in determining whether to accept or reject questionable or suspect studies.

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Inspections Evaluating the laboratory facilities, operations, and study performance. Organization Chart—If the facility maintains an organization chart, obtain a current version of the chart for use during the inspection. Facility Floor-plan Diagram—Obtain a diagram of the facility. The diagram may identify areas that are not used for GLP activities. Master Schedule Sheet—Obtain a copy of the firm’s master schedule sheet for all studies listed since the last GLP inspection or last 2 years and select studies as defined in 21 CFR 58.3(d)

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Identification of Studies a. Directed Inspections—Inspection assignments will identify studies to be audited. b. Surveillance inspections—Inspection assignments may identify one or more studies to be audited. 5.Ongoing Studies : Obtain a copy of the study protocol and determine the schedule of activities that will be underway during the inspection. This information should be used to schedule inspections of on-going laboratory operations, as well as equipment and facilities associated with the study 6. Completed Studies: If possible, accompany laboratory personnel when they retrieve the study data to assess the adequacy of data retention, storage, and retrieval as described in part III, C 10.

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The following areas should be evaluated and described as appropriate. Organization and Personnel a. Purpose: To determine whether the organizational structure is appropriate to ensure that studies are conducted in compliance with GLP regulations, and to determine whether management, study directors, and laboratory personnel are fulfilling their responsibilities under the GLPs b. Management Responsibilities Identify the various organizational units, their role in carrying out GLP study activities, and the management responsible for these organizational units. who are performing duties at locations other than the test facility and identifying their line of authority.

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2. Determine if management has procedures for assuring that the responsibilities in 58.31 Assigning and replacing study directors Control of study director workload c) Establishment and support of the Quality Assurance Unit (QAU), d) Assuring that test and control articles or mixtures are appropriately tested for identity, strength, purity, stability, and uniformity. e) Assuring that all study personnel are informed of and follow any special test and control article handling and storage procedures. f) Providing required study personnel, resources, facilities, equipment, and materials. g) Reviewing and approving protocols and standard operating procedures (SOPs).

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3. Personnel a. Summaries of training and position descriptions are maintained and are current for selected employees. b. Personnel have been adequately trained to carry out the study functions that they perform. c. Personnel have been trained in GLPs. d. Practices are in place to ensure that employees take necessary health precautions, wear appropriate clothing, and report illnesses to avoid contamination of the test and control articles and test systems . 4.computerized operations a. Who was involved in the design, development, and validation of the computer system? b. Who is responsible for the operation of the computer system

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C.Whether computer system personnel have training in GLPs? d. Whether some computer system personnel are contractors who are present on-site full-time, or nearly full-time. e. Interview and observe personnel using the computerized systems to assess their training and performance of assigned duties. 5. Study director: a. Assess the extent of the study director’s actual involvement and participation in the study b. Assess the procedures by which the study director

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assures the protocol and any amendments have been properly approved and are followed, ii. assures that all data are accurately recorded and verified, iii. assures that data are collected according to the protocol and SOPs, iv. documents unforeseen circumstances that may affect the quality and integrity of the study and implements corrective action v. assures that study personnel are familiar with and adhere to the study protocol and SOPs vi. assures that study data are transferred to the archives at the close of the study.

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6. EIR Documentation and Reporting SOPs, organizational charts, position descriptions, and curriculum vitae (CVs), as well as study-related memos, records 7. Quality Assurance Unit

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Maintenance of a master schedule sheet. Maintenance of copies of all protocols and amendments. Scheduling of its in-process inspections and audits. Inspection of each nonclinical laboratory study at intervals adequate to assure the integrity of the study, and maintenance of records of each inspection. Immediately notify the study director and management of any problems that are likely to affect the integrity of the study. Submission of periodic status reports on each study to the study director and management. Review of the final study report. Preparation of a statement to be included in the final report that specifies the dates inspections were made and findings reported to management and to the study director.

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8.Facilities Review environmental controls and monitoring procedures for critical areas (i.e., animal rooms, test article storage areas, laboratory areas, handling of bio-hazardous material, etc.) cleaning critical areas and equipment, and assess the facility’s current cleanliness. Appropriate areas for the receipt, storage, mixing, and handling of the test and control articles. separation is maintained in rooms where two or more functions requiring separation are performed. computer data are housed under appropriate environmental conditions (e.g., protected from heat, water, and electromagnetic forces).

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9.Equipment condition, cleanliness, and ease of maintenance of equipment The heating, ventilation, and air conditioning system design and maintenance, including documentation of filter changes and temperature/humidity monitoring in critical areas. Whether equipment is located where it is used and that it is located in a controlled environment, when required. Nondedicated equipment for preparation of test and control article carrier mixtures is cleaned and decontaminated to prevent cross-contamination.

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For representative pieces of equipment check the availability of the following: i ) SOPs and/or operating manuals. ii) Maintenance schedule and log. iii) Standardization/calibration procedure, schedule, and log. iv) Standards used for calibration and standardization 10.Testing Facility Operations Review the SOP index and representative samples of SOPs Verify that only current SOPs are available Verify that changes to SOPs are properly authorized and dated Verify that SOPs are periodically reviewed for current Applicability Review selected SOPs and observe employees performing the operation to evaluate SOP adherence and familiarity

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11.Reagents and Solutions Verify that reagents and solutions are labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Verify that for automated analytical equipment To determine that the facility ensures the quality of reagents at the time of receipt and subsequent use 12.Test and Control Articles the identity, strength, purity, and composition, the stability of test and control articles is documented; the transfer of samples from the point of collection to the analytical laboratory is documented; storage containers are appropriately labeled and assigned for the duration of the study; and reserve samples of test and control articles for each batch are retained for studies lasting more than 4 weeks.

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13.Protocol and Conduct of Nonclinical Laboratory Study a) Review SOPs for protocol preparation and approval and verify they are followed. b) Review the protocol to determine if it contains required elements. c) Review all changes, revisions, or amendments to the protocol to ensure that they are authorized, signed, and dated by the study director. d) Verify that all copies of the approved protocol contain all changes, revisions, or amendments. 14.Records and Reports Purpose: To assess how the test facility stores and retrieves raw data, documentation, protocols, final reports, and specimens.

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Storage and Retrieval of Records and Data Verify that raw data, documentation, protocols, final reports, and specimens have been retained. Data Audit Protocol Versus Final Report Final Report Versus Raw Data Inspectional Observations The findings are problems that have been observed and corrected by the firm through its internal procedures. The findings are minor and are one-time occurrences that have no impact on the firm’s operations, study conduct, or data integrity.

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